Most Recently Posted News

BioClinica to Present at BMO Capital Markets Focus on Healthcare Conference August 5

Wed, 28 Jul 2010 10:51:16 -0400

NEWTOWN, PA, July 28, 2010 – BioClinica, Inc. (NASDAQ: BIOC), a global provider of clinical trial management services, will be presenting at the BMO Capital Markets Focus on Healthcare Conference on August 5, 2010 at 4:00 p.m. EDT at the Sheraton New York Hotel & Towers in New York City.

Mark L. Weinstein, President and CEO will be discussing an overview of BioClinica, Inc., its business strategy and financial performance. The presentation will be simultaneously webcast and can be accessed at the following link:

http://www.bmocm.com/conferences/2010healthcare/webcast

Once you have accessed the link you will be provided specific instructions on how to connect to the BioClinica presentation.

BioClinica to Release Second Quarter 2010 Financial Results on August 4, 2010

Tue, 20 Jul 2010 08:57:26 -0400

-Conference Call to be Held at 11:00 a.m.-

NEWTOWN, PA, July 20, 2010 -- BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the second quarter ended June 30, 2010 on Wednesday, August 4, 2010.

Management of BioClinica, Inc. will host a conference call on the same day at 11:00 a.m. EDT. Those who wish to participate in the conference call may telephone 877-869-3847 from the U.S.; international callers may telephone 201-689-8261, approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call’s completion for two weeks, and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, Acct# 360; Replay ID# 353964. The replay will also be on the website under “Investor Relations” at www.bioclinica.com for two weeks.

BioClinica Introduces New Reporting Solution that Supports Metrics Champion Consortium

Tue, 15 Jun 2010 10:59:13 -0400

- Extends Standardized Performance Reporting Across Clinical Trials –

-To Be Demonstrated at DIA Annual Meeting Through June 16 in Washington, D.C.-

NEWTOWN, PA, June 15, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, is the first clinical technology provider to offer a reporting solution that incorporates the industry-standard performance metrics for clinical trials as defined by the Metrics Champion Consortium (MCC).

BioClinica is a Corporate Sponsor of the Metrics Champion Consortium (MCC), an open, collaborative organization dedicated to fostering the development of performance metrics for both Sponsors and Service Providers in support of an improved drug development process. BioClinica has supported the definition of both Imaging and Clinical Trials metrics through its participation in the MCC. “BioClinica is a vigorous supporter of standards initiatives such as the MCC and CDISC. Standards help the industry drive efficiency and facilitate transparency of the data associated with clinical trials,” said Peter Benton, President of BioClinica’s eClinical Division.

BioClinica Unveils Platform for Integrated Clinical Operations Based on Microsoft Technologies

Mon, 14 Jun 2010 09:15:37 -0400

- Will Demonstrate eClinical Technology Innovation at 46thDIA Annual Meeting, June 13-17 -

NEWTOWN, PA, June 14, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, will exhibit at the 46th Drug Information Association (DIA) Annual Meeting from June 13- 17, 2010 in Washington, D.C., where it will showcase the BioClinica eClinical Technology Suite as well as introduce the BioClinica Integrated Operations Platform (BIOP). This advancement in clinical support technology leverages the power, the familiarity, and the ubiquity of Microsoft Office and SharePoint platforms to deliver a real world window on clinical operations -- across studies and across clinical technologies.

This far-reaching development will enable BioClinica to make mission-critical operational data accessible in Microsoft Office and SharePoint applications that most customers already use.

BioClinica to Present at Sidoti Companys Semiannual New York Micro Cap Conference

Thu, 10 Jun 2010 10:13:25 -0400

NEWTOWN, PA, June 10, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, will be presenting at the Sidoti & Company’s Semiannual New York Micro-Cap Conference on June 25, 2010 at 8:40 a.m. EDT at the Grand Hyatt Hotel in New York City.

Mark L. Weinstein, President and CEO of BioClinica will review the company’s robust suite of clinical trial services and provide an update on its business.

BioClinica to Participate in Upcoming Leading Healthcare Conferences

Thu, 27 May 2010 16:27:50 -0400

NEWTOWN, PA, May 27, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced it will exhibit and present at several key, upcoming healthcare conferences scheduled during June and July.

June 2-3, 2010
Clinical Trials Supply West Coast 2010
San Francisco, CA
Booth #2

Ed Tourtellotte, Vice President of Product Innovation, will present on Optimizing and Simulation in Order to Ensure ROI Throughout Your Supply Chain on June 2 at 2:30 p.m. During this presentation he will discuss how to analyze the clinical supply chain before and during the trial, assessing the different effects and impacts of a supply chain, and trimming costs through the examination of overages, supply parameters and enrollment. BioClinica will also showcase its Optimizer clinical supply simulation solution.

Click here to view the complete list of conferences scheduled through July »

BioClinica Announces First Quarter 2010 Financial Results

Wed, 05 May 2010 09:55:07 -0400

-- Conference Call Today at 11:00 A.M. EST --

NEWTOWN, PA, May 5, 2010 – BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial management services, today announced its financial results for the first quarter ended March 31, 2010. Financial highlights for the quarter ended March 31, 2010 include:

Service revenues were $14,746,000 as compared with $14,475,000 for the same period 2009.
Backlog was $99.7 million as of March 31, 2010, as compared with $93.3 million as of March 31, 2009.
Non-GAAP income from operations was $1,748,000 as compared with $1,577,000 for the same period 2009.
GAAP income from operations was $1,167,000 as compared with $1,222,000 for the same period 2009.
Non-GAAP net income was $1,065,000, or $0.07 per fully diluted share, as compared with $1,010,000, or $0.07 per fully diluted share, for the same period 2009.
GAAP net income was $711,000, or $0.05 per fully diluted share, as compared with $786,000, or $0.05 per fully diluted share, for the same period 2009.

In addition, the Company reported several milestones in its growth strategy, including:

The acquisition of TranSenda International, including its Office-Smart Clinical Trial Manager (“CTMS”) and Office-Smart Clinical Payment Manager, each designed to take full advantage of the powerful Microsoft Office tools and based on native interoperability with the Microsoft SharePoint System.
The launch of BioClinica WebSend and WebView which provide best-in-class regulatory compliant electronic image transport solutions for its medical image management clients worldwide.
The signing of a multi-year “end-to-end” clinical data management outsourcing agreement with Cephalon, Inc.
The launch of BioClinica Optimizer, a leading product in the field of clinical supply chain forecasting and optimization, with four of the top ten pharmaceutical companies among its clients.
Reaching the final development stages of its Trident IVR/IWR, the next generation of Interactive Voice Response/ Interactive Web Response (“IVR/IWR”) software.

BioClinica to Release First Quarter 2010 Financial Results on May 5, 2010

Tue, 20 Apr 2010 09:48:39 -0400

NEWTOWN, PA, April 20, 2010 -- BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the first quarter ended March 31, 2010 on Wednesday, May 5, 2010.

Management of BioClinica, Inc. will host a conference call on the same day at 11:00 a.m. EDT. Those who wish to participate in the conference call may telephone 877-869-3847 from the U.S.; international callers may telephone 201-689-8261, approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call’s completion for two weeks, and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, Acct# 360; Replay ID# 349492. The replay will also be on the website under “Investor Relations” at www.bioclinica.com for two weeks.

BioClinica Acquires Cephalon's U.S. Data Management Team

Mon, 26 Apr 2010 12:16:29 -0400

As Posted on ecliniqua.com

By Deb Borfitz

April 19, 2010 | International biopharmaceutical firm Cephalon, Inc. has transferred its U.S.-based data management staff to BioClinica, Inc. as part of a multi-year outsourcing deal with the electronic data capture (EDC) provider. The unprecedented move gives BioClinica the lion’s share of Cephalon’s data management work as well as an enriched human resource pool deployable to other projects and customers, says BioClinica President and CEO Mark Weinstein. The deal also makes BioClinica’s web-based Express^TM the default EDC system for Cephalon-sponsored clinical trials.

Specific tasks being outsourced to BioClinica include data management planning, clinical study set-up for EDC, medical coding, adverse event reconciliation, clinical data management, and training of clinical sites and investigators.

BioClinica (formerly Bio-Imaging Technologies) acquired EDC capabilities with its March 2008 acquisition of Phoenix Data Systems, with whom Cephalon began working five years earlier. Data management services have increasingly been coupled with Express^TM per the preference of sponsor firms, says Peter Benton, president of BioClinica’s eClinical Services Division. The company currently provides some level of data management for more than half of its EDC clients. Their other alternatives are to outsource the work to a full-service clinical research organization (CRO), “staff above expectations” internally, or work overtime to deal with periodic but inevitable data surges.

“Certainly no one knows EDC and our Express^TM platform better than BioClinica’s data management team,” says Benton. “They work with [Express^TM] all day long and know all they can about what can go wrong and right with the design of a clinical study. There is little they’ve not seen.”

For Cephalon’s data management team, the transition to BioClinica was seamless. The same people are doing the same work on the same studies, just in a different location, and they’re “excited” by the prospect of working on projects beyond Cephalon, says Weinstein.

BioClinica will essentially be an “extension” of Cephalon’s standardized drug development process and work with other functional service providers to optimize operational efficiencies, says Benton. “Cephalon is one of the companies that ‘gets’ it and has embraced a better way of running clinical trials.”

More data management deals, with or without the employee transfer feature, might be on the horizon for BioClinica. “Many of the key decision makers at small- and mid-size pharma companies formerly worked for larger firms that owned and managed non-core services like data management and the associated IT infrastructure,” says Weinstein. “They know that’s what they don’t want.” In fact, most would prefer to be “virtual” and only contract for the work as needed.

The “full service” strategy is a differentiator for BioClinica, as both the smaller and the larger EDC players are generally technology-only vendors. CROs are the traditional purveyors of data management services, but sponsors are forced to switch platforms every time they switch CRO partners, says Benton. “Can you imagine switching your finance system every time you outsourced another trial? The benefit of using BioClinica is…[that sponsors] can run their trials their way, the same way, every time. That’s the secret to running an effective development organization.”

Sponsors want to standardize to a single clinical business process and platform, even if they use different CRO partners, continues Benton. To do otherwise breeds inefficiency and can significantly, but unnecessarily, increase study start-up times. “If you keep changing [technologies and processes] trial to trial and compound to compound, you have to keep re-learning the same things over and over.”

Read the complete story

BioClinica Showcases Global Capabilities at Upcoming Industry Conferences

Mon, 12 Apr 2010 08:54:27 -0400

NEWTOWN, PA, April 12, 2010 – BioClinica, Inc. (NASDAQ: BIOC), a leading provider of clinical trial management services will participate in, and present at, key industry conferences during April and May. Principal members of the BioClinica team will participate as expert panelists as well as demonstrate the value of the Company’s expanded suite of services at these conferences.

BioClinica Launches WebSend and Creates Efficiencies for Clinical Trial Imaging Delivery

Thu, 08 Apr 2010 08:51:24 -0400

NEWTOWN, PA, April 8, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced the release of BioClinica WebSend, a system that simplifies and accelerates image collection for clinical studies. WebSend transfers and tracks medical images in real-time, offering key benefits over the standard manual transport methods commonly used in imaging trials, including faster delivery of image data, enhanced data quality with fewer site queries, and reduced cost.

BioClinica WebSend is complemented by BioClinica WebView, the proven and established solution for managing the electronic sharing, blinding, tracking, archiving and analysis of medical images for clinical trials worldwide. Originally developed over 10 years ago by CardioNow, a business acquired by BioClinica from Agfa HealthCare in August 2009, BioClinica WebSend and WebView have evolved into a best-in-class solution for delivering true electronic clinical trial image management.

BioClinica Acquires Transenda International, LLC

Fri, 26 Mar 2010 07:21:31 -0400

NEWTOWN, PA, March 26, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced its acquisition of substantially all of the assets of privately held TranSenda International, LLC (“TranSenda”). Headquartered in Bellevue, WA, TranSenda is a provider of clinical trial management software (CTMS) solutions and is a Microsoft Gold Certified Partner.

TranSenda’s innovative suite of web-based, Office-Smart CTMS solutions and patent-pending integration technologies create efficiencies for trial operations through interoperability with Microsoft Office tools. With this acquisition, BioClinica enhances its ability to serve customers throughout the clinical research process with technologies that include improved efficiencies by reducing study durations and costs through integrated operational management.

BioClinica Partners with Health Sciences International and PRL Central Laboratory Services

Thu, 04 Mar 2010 08:52:53 -0500

NEWTOWN, PA, March 4, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced it has created strategic partnerships with two clinical research organizations (CROs), Health Sciences International, Inc., and PRL Central Laboratory Services. Both alliances strengthen the BioClinica Certified Partner Program, a group of VIP CRO partners chosen based on therapeutic expertise and customer satisfaction.

BioClinica Launches Optimizer to Improve Clinical Trial Supply Planning

Thu, 25 Feb 2010 08:43:02 -0500

NEWTOWN, PA, February 25, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced the launch of BioClinica Optimizer, a breakthrough for clinical supply planning and management that it believes has the potential to transform clinical trial supply forecasting and management. BioClinica Optimizer is a new product that combines and enhances the features of tcVisualize and tcOptimizer developed by Tourtellotte Solutions, which was acquired by BioClinica in September 2009. Allowing a customer to move beyond the current environment of spreadsheets and manual tools to plan and analyze clinical supply chains programmatically, BioClinica Optimizer integrates planning and feedback loops with other eClinical technologies.

“BioClinica now offers the premiere eClinical solution available to help our customers plan, forecast and optimize their clinical trials,” said Mark Weinstein, CEO of BioClinica, Inc. “Optimizer provides customers the ability to streamline this vital process, potentially saving them hundreds of thousands of dollars per trial. This enhanced product is indicative of the types of services BioClinica strives to offer our customers, providing access to the highest quality tools and experience to help them maximize productivity and results. We believe BioClinica Optimizer sets a new benchmark for the planning of clinical studies.”

BioClinica Optimizer, including the original versions, has achieved successful results in hundreds of clinical trials across the globe, with four of the top ten pharmaceutical companies already using BioClinica’s clinical supply forecasting solutions. For example, in a recent trial involving 10 countries and 150 sites, Optimizer enabled the customer to save over $1.2M in supplies.

BioClinica Will Be Showcased at Upcoming Industry Conferences

Tue, 23 Feb 2010 09:01:05 -0500

NEWTOWN, PA, February 23, 2010 – BioClinica, Inc. (NASDAQ: BIOC), a global provider of clinical trial management services will participate in, and present at, key industry conferences during February and March. Key members of the BioClinica team will participate as expert panelists as well as demonstrate the value of the Company’s expanded suite of services at these conferences.

TranSenda To Participate At CHI's SCOPE Conference

Fri, 02 Apr 2010 12:01:54 -0400

Cambridge Healthtech Institute’s Summit for Clinical Ops Executives

Bellevue, WA – February 15, 2010

TranSenda International, LLC, today announced its chief executive officer and president, Robert Webber, will facilitate a discussion group and present a topic at Cambridge Healthtech Institute’s (CHI) Summit for Clinical Ops Executives (SCOPE) at the Crowne Plaza in Philadelphia, Pennsylvania. SCOPE is a four day event taking place March 8-11, 2010 in conjunction with the second annual Electronic Data in Clinical Trials: Collecting and Leveraging Data to Optimize Clinical Trials. The gathering also features a one-day seminar, eCTD 2010, co-hosted with Bio-IT World and eCliniqua.

TranSenda’s CEO will guide a discussion on Overcoming Challenges in Integrating Systems (EDC, IVRS, CTMS) and Clinical Operations Data at 4:15pm ET on March 8, 2010. The session will cover topics such as major obstacles for integration of clinical systems, the role of standards in achieving integration goals, experiences that have and have not worked, and what technologies and techniques are on the horizon. On Day Two, March 9th at 9:45am ET, TranSenda’s CEO will also present Increasing Clinical Trial Efficiency through Operational Data Management. This session will include real-world examples and solutions to help clinical trial professionals faced with attempting to manage studies that involve a myriad of disconnected software applications.

CHI’s conference is a multi-faceted event intended “to cover the challenges related to which technologies and systems to use, measuring the ROI of technology investment, and how best to overcome the common problems with implementation”. For more information about SCOPE and CHI’s Electronic Data in Clinical Trials conference visit the Events section on TranSenda’s website.

BioClinica Announces Fourth Quarter and Year End 2009 Financial Results

Wed, 10 Feb 2010 10:28:42 -0500

NEWTOWN, PA, February 10, 2010 – BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, today announced its financial results for the quarter and year ended December 31, 2009. The operating results of Phoenix Data Systems (“PDS”) are included in the financial results following the acquisition of PDS that was completed March 24, 2008. The CapMed division, which was sold on January 6, 2009, was reclassified as a discontinued operation for all periods presented.

BioClinica Inks Multi Year Outsourcing Deal with Leading Biopharmaceutical Company

Thu, 04 Feb 2010 10:36:38 -0500

NEWTOWN, PA, February 4, 2010 – BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, has signed a three-year, multi-million dollar deal with Cephalon, Inc. for clinical trial technology and support services. As part of the Service Agreement, US-based data management staff at Cephalon will be hired by BioClinica to support clinical efforts of Cephalon.

BioClinica will provide end-to-end clinical data management services to Cephalon global clinical trial operations. Specific tasks include data management planning, clinical study set-up for electronic data capture (EDC), medical coding, adverse event reconciliation, clinical data management, and training for the clinical sites and investigators. The deal also expands plans by Cephalon to use BioClinica’s ExpressTM electronic data capture (EDC) product as the default data capture system across clinical trial phases, from Phases I through IV. BioClinica will work with other functional service providers selected as part of Cephalon’s initiative to optimize operational efficiency. BioClinica said it will see its role with Cephalon extended from one of a technology provider to that of a “key services partner”.

BioClinica to Host Fourth Quarter and Year End 2009 Financial Results Conference Call on 10 Feb 2010

Wed, 03 Feb 2010 10:03:32 -0500

NEWTOWN, PA, February 3, 2010 -- BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the fourth quarter and full year ended December 31, 2009 on Wednesday, February 10, 2010.

Management of BioClinica, Inc. will host a conference call on the same day at 11:00 a.m. EST. Those who wish to participate in the conference call may telephone 877-869-3847 from the U.S.; international callers may telephone 201-689-8261, approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call’s completion for two weeks, and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, Acct# 360; Replay ID# 342457. The replay will also be on the website under “Investor Relations” at www.bioclinica.com for two weeks.

Robert Sammis Joins BioClinica as VP of Finance for eClinical Division

Tue, 02 Feb 2010 09:39:37 -0500

NEWTOWN, PA, February 2, 2010 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced the addition of Robert Sammis as the new vice president of finance for the company’s eClinical Division.

Reporting to Peter Benton, President of the eClinical Division, Sammis will oversee the finance and human resources functions for the eClinical Division. He will be responsible for developing plans, budgets, forecasts and financial results to guide management decisions. In addition, he will drive initiatives to develop, implement, analyze and monitor standardized costing methodologies, and approaches for operations and service delivery. His skills include financial analysis, controls and reporting, profitability restructuring and acquisition assimilation, as well as healthcare experience. As part of the BioClinica team, he will help shape and guide the company’s eClinical strategic direction and execution.

BioClinica to Present at Jefferies 2010 Global Healthcare Conference 27 January 2010

Wed, 20 Jan 2010 09:08:42 -0500

NEWTOWN, PA, January 20, 2010 – BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, will be presenting at the Jefferies Inaugural Global Healthcare Services Conference on January 27, 2010 at 4:30 p.m. EST in New York City.

Mark L. Weinstein, President and CEO of BioClinica will be reviewing the company’s robust suite of clinical trial services and will provide an update on its business. A simultaneous webcast of the presentation can be accessed through the following link, and will be available for 90 days.

BioClinica To Present At Sidoti & Company's First 2010 Micro Cap Conference On January 11, 2010

Tue, 05 Jan 2010 10:58:26 -0500

NEWTOWN, PA, January 5, 2010 – BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services,, will be presenting at the Sidoti & Company’s First 2010 Micro Cap Conference on January 11, 2010 at 9:50 a.m. EST at the Grand Hyatt Hotel in New York City.

Mark L. Weinstein, President and CEO of BioClinica will be reviewing the company’s robust suite of clinical trial services and provide an update on its business.

BioClinica Honored as Technology Company of the Year at Eastern Tech Councils Enterprise Awards

Tue, 08 Dec 2009 13:09:16 -0500

NEWTOWN, PA, December 8, 2009 – BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, today announced it has been named the Technology Company of the Year at the Eastern Technology Council Enterprise Awards. The Philadelphia region's most prestigious business honor for technology and life sciences companies, leaders and entrepreneurs, the award recognizes a company for its leadership, product and service innovations, significant company milestones, and community and industry involvement. The award was received at the Eastern Technology Council’s 17th annual Enterprise Awards gala on December 3, 2009.

BioClinica Adds Image Transport to its Integrated Product Suite

Mon, 16 Nov 2009 16:00:12 -0500

As posted on eCliniqua's website:

By Deb Borfitz

November 16, 2009 | Medical device companies will be the most immediate beneficiaries of the expanded capabilities of BioClinica, the result of its recent acquisition of electronic image transport specialist CardioNow. In particular, device makers are interested in the integration of BioClinica Express electronic data capture (EDC) with BioClinica’s new ability to securely deliver trial-related images over the Internet from clinical sites to imaging core labs, says president and CEO Mark Weinstein.

The CardioNow purchase brings BioClinica a strong reputation in the cardiovascular medical device field, dominated by tech-savvy academic medical centers that have been transmitting images electronically since 2000, says Weinstein. Trial efficiency is critical with devices, given that they may have only a two-year shelf life before an improved version hits the market. Subject recruitment for trials can’t turn into the two-year ordeal it often is for drugs. Recruitment more typically happens in a concentrated time period, all but requiring digitalization to process the bolus of information accruing over two or three months.

To date, BioClinica has coupled EDC and image management services for five studies, says Weinstein. The CardioNow acquisition gives BioClinica a “total turnkey offering” for device companies that will likely grow business volume in that sector, which historically represented a less than 10% slice of overall revenues.

CardioNow, a unit of Agfa HealthCare, has successfully managed more than 8.8 million DICOM (Digital Imaging and Communications in Medicine) cardiac images on behalf of about 500 institutions worldwide since 1999, says Weinstein. That should make it sufficiently vetted even for the notoriously risk-averse pharmaceutical sector.

Together with its bio-imaging, EDC, and interactive voice/web response capabilities (from its most recent acquisition of Tourtellotte Solutions), BioClinica has a “comprehensive offering truly unmatched in the industry,” says Weinstein. An integrated, end-to-end product suite holds increasing appeal to pharmaceutical companies that want to leverage their hefty investments in data management.

BioClinica will be extending CardioNow’s capabilities to its other areas of therapeutic expertise—notably oncology, neurology, and musculoskeletal—and offering it as an option on the more than 200 studies on which it is currently managing medical images, says Weinstein. The company receives medical images and data from approximately 11,000 independent imaging centers in 83 countries. “We’ve been in this space a long time [since 1990] and more than 90% of the time we still receive electronic images…on a disk in an envelope.”

Study sponsors could see transmission fees shrink by 15% to 20% for every imaging center that opts to send images electronically rather than by FedEx or courier service, says Weinstein. But the transition could take awhile. Not all imaging sites have the Internet connectivity necessary to handle such large files and they’re not financially motivated to make the switch to broadband. Scans related to clinical research account for less than 1% of overall revenues at most sites.

Trial sponsors generally don’t mandate electronic image transmission, fearing it will limit patient recruitment wherever bandwidth is limited. BioClinica, for its part, is happy to receive patient data by whatever means necessary, says Weinstein, adding that it still has the same number of employees opening FedEx envelopes. But the efficiency and quality gains of sending images electronically has growing appeal to sponsors, and vendors are emerging that cater to this newfound interest. Offering “one-stop shopping” for image transmission and EDC thus keeps BioClinica preemptively ahead of the competition.

The CardioNow acquisition came with less than $1 million in annual revenues, says Weinstein, but not for want of greater potential. It was the property of Heartlab, Inc. before being acquired by Agfa HealthCare in 2005 and “couldn’t get [sufficient] corporate attention to build the business.”

Whether or not the CardioNow moniker is retained, the business it represents should be invigorated under BioClinica’s corporate umbrella. The publicly traded company, created from the acquisition of Phoenix Data Systems by Bio-Imaging Technologies, has money in the bank and no debt. “It’s what differentiates us among small players” providing clinical trials services, Weinstein says, “especially when sponsors are embarking on a three- to-five-year study.”

Click here to read the full article >>

BioClinica to Host Medical Imaging Symposium for Rheumatoid Arthritis Clinical Trials on November 18 2009

Mon, 09 Nov 2009 21:57:06 -0500

NEWTOWN, PA, November 10, 2009 – BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced it will be hosting a seminar on November 18, 2009 highlighting new research, trends and updates from industry experts in rheumatoid arthritis. This event, which will be held in Lafayette, PA, is part of the continuing series of symposia hosted by the company for pharmaceutical and medical imaging executives over the past four years that addresses the challenges and approaches in conducting clinical trials.

Rheumatoid arthritis studies in Phase III trials generally rely on radiographs to determine the imaging endpoints. In addition, MRI has become an essential imaging modality for the assessment of rheumatoid arthritis patients, particularly in the Phase II setting. BioClinica has helped support image collection and central reads in clinical trials for five separate FDA-approved therapeutic agents for the treatment of rheumatoid arthritis, all of which are currently being marketed and used worldwide.

BioClinica Announces Third Quarter 2009 Financial Results

Wed, 04 Nov 2009 13:56:41 -0500

NEWTOWN, PA, November 4, 2009 – BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, today announced its financial results for the quarter and nine months ended September 30, 2009. The operating results of Phoenix Data Systems (“PDS”) are included in the financial results following the acquisition of PDS that was completed March 24, 2008. The CapMed division, which was sold on January 6, 2009, was reclassified as a discontinued operation for all periods presented.

We are commencing the presentation of certain non-GAAP financial information that we believe is useful in assessing our core operating performance, evaluating our ongoing business operations and comparing our results of operations on a consistent basis from period to period. We are providing information for 2009 and 2008 non-GAAP income from continuing operations before interest and taxes, non-GAAP income from continuing operations net of taxes, and non-GAAP diluted earnings per share. The non-GAAP information excludes the impact of stock-based compensation, amortization of intangible assets related to acquisitions, restructuring charges and merger and acquisition costs. See further discussion and information in “non-GAAP financial information” paragraph and “GAAP to non-GAAP Reconciliation” table below.

To listen to the conference call please go to www.bioclinica.com/investors

Company Interview Excerpt BioClinica, Inc. - Mark L. Weinstein

Tue, 15 Dec 2009 17:08:29 -0500

As posted in The Wall Street Transcript:

The Wall Street Transcript. Connecting Market Leaders with Investors

MARK L. WEINSTEIN has led BioClinica — formerly Bio-Imaging Technologies, Inc. — as the President and Chief Executive Officer since February 1998. He has also been a member of the board of directors since March 1998. Mr. Weinstein joined Bio-Imaging Technologies, Inc., in June 1997 as Senior Vice President of Sales and Marketing. Prior to joining Bio-Imaging Technologies, Inc., he was the Chief Operating Officer of Internet Tradeline, Inc., an Internet-based electronic solutions provider. From July 1991 to August 1996, Mr. Weinstein worked for Medical Economics Company, an international health care information company and wholly owned division of The Thomson Corporation. He held several senior management positions at Medical Economics Company, serving finally as President and Chief Operating Officer of the International Group. Mr. Weinstein received his bachelor’s degree in economics from the University of Virginia and his MBA from the College of William and Mary.

Click here to read the full article >>

eClinical for Today and Tomorrow

Wed, 25 Nov 2009 15:58:49 -0500

As posted in DIA's Global Forum:

Jonathan Andrus

As eClinical concepts continue to emerge throughout the drug discovery and development spectrum, they become more important and frequent topics for discussion among industry professionals of every function and discipline. Jonathan Andrus, MS, CQA, CCDM (BioClinica, Inc.), who serves as Chair of the DIA eClinical SIAC and also on the Board of the Society for Clinical Data Management, shared these thoughts on the importance of eClinical initiatives to industry, and the value of the eClinical SIAC to the DIA member and volunteer community.

There has been much discussion but seems to be precious little consensus: Like the word “interface,” is “eClinical” a noun (a thing) or is it a verb (an action or process)?

eClinical is a thing, or a series/collection of things. It constitutes the process or conduct of clinical trials in an electronic manner. It is the application of a thing or things (a noun or nouns) to a verb (action or process) to enable the management of a clinical trial. eClinical tools are a noun, but their application to our processes is a verb. How you use it within the clinical trial environment is what’s important.

If most experts agree that “eClinical” and “electronic data capture” are related but are not synonymous terms, then why do they seem to be so often used interchangeably?

They are absolutely related, but they are not the same. EDC, electronic data capture, is one of many eClinical tools that are used by clinical research professionals to complete clinically oriented tasks (data collection, monitoring, site payments, randomization, study drug management and patient-reported data collection, to name a few). eClinical allows for data to be collected in a less arduous and manual manner. In talking about eClinical, people often refer to EDC because that is the most commonly recognized, and had been used probably the longest and most widely, of eClinical tools.

How can eClinical initiatives help advance the pharmaceutical industry’s current emphases on transparency and drug safety?

Through the use of these eClinical tools, stakeholders (professionals in clinical, data, and statistics departments, plus senior management) can have access to their data in a more real-time and in theory, better quality way. Data can be quickly accessed and presented to a wide variety of audiences to provide early detection of trends in safety, enrollment/recruitment, data quality and study design. These tools can be used to improve overall data quality and lead to quicker, more assured study decisions. This also leads to the transparency you suggest in your question. Through the use of eClinical tools, one can gauge data quality and data integrity by looking for query trends, data changes, study design changes, etc.

Further, using web-based reporting tools provides the transparency needed to keep an eye on all eClinical data. All parties involved can gain insight into the data and determine how personnel are performing. Are they conducting their site visits when expected? How much work are they getting done when they are onsite? What additional/refresher training might be needed to address observed trends? How are the data managers doing? Are queries being cleaned up and addressed in a timely manner? How is coding moving along? Judging from the way that AE and ConMed terms are being reported, is additional training needed? What are the type and significance of adverse events that are being reported? These are just some examples of the transparency and drug safety items that can be addressed through eClinical!

It’s not just about data management or validation or ePRO: It’s about all the different eClinical tools and processes. We’re all clinical research professionals. Maybe a subject matter expert who’s a data manager shares insight or guidance with a CRA to help them better perform their role during monitoring; conversely, the CRA can say, “While I’m monitoring, it would be really helpful if you were doing these things from a study design perspective or the way that you word your queries.” How can you use these tools to make the clinical trial process – the verb – much more effective by using the tools – the noun – to improve data quality, transparency, and safety. How are we doing from a query management perspective? Are my monitors performing in accordance with timelines? Are there areas of the study design that are confusing the sites, which we’re seeing through an increased number of data discrepancies? Maybe it requires refresher training – you know, actually use eClinical tools to help affect study outcomes.

What needs of the clinical research/drug development community can the eClinical SIAC help meet?

We are looking to tackle topics related to the successful implementation and use of eClinical tools in the conduct of clinical trials, and how to properly deploy and utilize these tools to further advance issues previously discussed: How do we integrate and interface more effectively with existing tools to help reduce redundant data collection? How do we utilize standards within eClinical to help speed and improve the quality of planning, designing, and developing clinical trials? What areas are people within industry struggling with? How can we work more effectively across all of clinical research? We want to get away from best practices for the data manager, or best practices for the CRA, but rather embrace more of a model of best practices for the Clinical Research Professional. How can the functional, specific roles within the clinical research profession work more effectively together? What can a data manager share with a CRA that would make their job more effective and more fulfilling, and in turn, what can a CRA share with a data manager that would help to improve the processes that they employ in eClinical? Getting all clinical research parties working toward a more common and cohesive goal is a big goal of the eClinical SIAC: We are looking to tackle topics related to the profession in a way that brings together different subject matter experts to arrive at cohesive conclusions.

One of the reasons I was drawn to the eClinical SIAC is that eClinical is kind of a “clearing house” of all these different tools, processes, people, and resources that need to come closer together. These eClinical tools are forcing us to work more closely together, but people are still kind of pushing back. I really feel strongly that the eClinical SIAC is a great place to start to break down some of those industry “silos.” eClinical embodies and covers all these different areas. I cannot emphasize this enough: We’re not data managers, not CRAs, not statisticians, but we’re all “CRPs,” clinical research professionals. And if you view it that way, this eClinical SIAC should really be geared to serving these needs and developing best practices and guidance that benefit all of us, not just one single group. That’s the area that can be bridged with this SIAC and what will be of most interest to our association.

What did we not ask you that you would like to share about eClinical initiatives?

It is important to note that anyone can get involved and be a part of this change. Don’t just sit back and wait for a society, association, or consortium to bring standards and guidance to you. Be a part of its development. Have a say in the future. Be on the cutting edge of industry changes. Be a participant, not a spectator! To get involved, share ideas or brainstorm, feel free to contact me directly at jonathan.andrus@bioclinica.com

Click here to read the full article >>

BioClinica, Inc. to Release Third Quarter 2009 Financial Results and Host Conference Call on November 4, 2009

Wed, 28 Oct 2009 14:06:23 -0400

NEWTOWN, PA, October 28, 2009 -- BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the third quarter ended September 30, 2009 on Wednesday, November 4, 2009.

Management of BioClinica, Inc. will host a conference call on the same day at 11 a.m. EST. Those who wish to participate in the conference call may telephone 888-335-6674 from the U.S.; international callers may telephone 973-321-1100, approximately 15 minutes before the call. The conference ID# for both numbers is 36541392. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call’s completion for two weeks, and may be accessed by dialing 800-642-1687 from the U.S. or 706-645-9291 for international callers, conference ID# 36541392. The replay will also be on the website under “Investor Relations” at www.bioclinica.com for two weeks.

Bioclinica Showcases Clinical Data Management at SCDM Annual Conference

Tue, 29 Sep 2009 15:53:42 -0400

NEWTOWN, PA, September 29, 2009 - BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, is helping to advance the discipline of clinical data management and will demonstrate integrated eClinical and imaging data management technology and expertise at the 2009 Society of Clinical Data Management (SCDM) Annual Conference, October 4-6, 2009 in Seattle, WA (Booth # 401). Company experts will share their knowledge of the industry and case studies illustrating the results of improved clinical data management practices. BioClinica is the Diamond Sponsor of the SCDM 2009 Annual Conference.

BioClinica Acquires Tourtellotte Solutions

Tue, 22 Sep 2009 15:48:21 -0400

As posted on eCliniqua's website:

By Kevin Davies

September 21, 2009 | BioClinica, a publicly traded e-clinical service provider, has acquired Tourtellotte Solutions, a Massachusetts software firm founded by Ed Tourtellotte, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software. BioClinica, which was forged when Bio-Imaging Technologies acquired Phoenix Data Systems 18 months ago, offers medical image management, electronic data capture (EDC), and other services to maximize manageability.

Peter Benton, executive VP and president of the eClinical division at BioClinica, says the firm was attracted to many aspects of Tourtellotte's technology. "We're looking for enhancements, anything that helps speed up and improve both the design and execution of clinical trials," Benton told eCliniqua. "Whether it's imaging, EDC, IVR... there's a huge opportunity to bring radical improvements in the drug development process and in how products are brought to market."

Tourtellotte says his overriding priority was to bring his small firm's groundbreaking products to the clinical trial market. "There are many reasons why I'm thrilled with the BioClinica acquisition, but the most prominent is that we're significantly accelerating our path into the world with what I think are next-gen clinical trial innovations," he said.

BioClinica paid $2.1 million in cash, with additional payments up to $3.2 million and 350,000 BioClinica shares contingent upon achieving certain milestones. Tourtellotte Solutions generated nearly $4 million in revenue last year, a figure that is expected to approach $5 million in 2009. Tourtellotte joins BioClinica as vice president of product innovation.

Tech Targets
Back in 2004, Tourtellotte's firm developed a novel piece of simulation software called tcVisualize, which enabled pharma companies to simulate the clinical supply chain, ensuring that sufficient drug supplies reached the sites. Launched in 2006, Benton calls tcVisualize, currently in use by four of the top ten big pharma companies, "a very cool technology. If it's not bleeding edge, then it's definitely leading edge compared to the alternatives, he says. "The competition is spreadsheets and manual calculations."

Tourtellotte says his software helps pharma companies save 40-60% of the amount of a drug compared to what might have been packaged. However, "There are other times you have to package more drug to make the trial run right-the savings there is you've saved the trial. You've saved the emergency mitigations, which is very expensive."

Listening to Tourtellotte reminds me of the old MasterCard commercial: Value of drug saved in a single clinical trial: $800,000. Cost of saving the trial: priceless.

Tourtellotte's novel IVR/IWR solution, packaged as a product called Trident, is parameter-driven, built specifically for the web, and able to support rapid customization. The software is currently in use in more than 150 clinical trials, and has been used in some 300 trials overall.

"The optimization/simulation market may be smaller," says Benton, "but the ability of that combined with the Tourtellotte team's expertise in managing the drug supply business, makes the technology developed in the Trident platform a huge opportunity."

The IVR/IWR market may be growing quickly, but Benton charges there hasn't been any new technology in the space for several years. "We think [Trident] is absolutely the latest and greatest technology of everything that's out there. To some degree, the existing vendors and services are really suffering from an inability to quickly scale. With the private IVR we've built, and some of the principles underlying Trident, it's all about quick building and scalability."

BioClinica had a sizable IVR/IWR business, says Benton, but now plans to fully integrate Trident technology. From now on, says Benton, "If you have an IVR, you have an EDC; if you have an EDC, you have an IVR.... Customers may not buy all those technologies and services, but [we are] building a truly integrated solution that does not exist elsewhere on the marketplace."

"We're vehement in our passion for integration of those technologies," says Benton.

Most of BioClinica's clients also want the services to support the range of technologies on offer. Benton says that customers aren't interested in juggling multiple datasets from an EDC vendor, their IVR vendor, their imaging vendor, their CRO, and so on. Integrating the Tourtellotte technology, coupled with BioClinica's reach to most of the top pharma companies provides "a huge opportunity for cross selling."

BioClinica and Tourtellotte had been talking for a long time before the deal was consummated. Tourtellotte says it was the "shared vision and shared goals" that persuaded him this was the right time. Benton says, "It's the people, really," which sounds like a cliché, but Benton pursues the point. BioClinica now adds the expertise of the Tourtellotte team to former Phoenix Data Systems and Bio-Imaging employees. "That's what our customers are hiring," Benton insists. "‘How can I get a study up and going as fast as possible?' ... and our ability to react to the things that neither the sponsor nor us realize are going to go wrong."

I asked Benton if this was BioClinica's last acquisition for a while. "I don't think so," he said. "We announced CardioNow last week, Tourtellotte this week. At this point, we don't have any plans for next week!" He adds that BioClinica has been run very conservatively, with no debt and plenty of cash in reserve. "We have a track record of doing smart acquisitions and culturally integrating these companies into a bigger stronger team."

As for Tourtellotte, he first plans to finish and integrate Trident. And then? "Now we've got a real R&D organization and a real budget, not just a shoestring. You might see some more innovation from us!"

Click here to read the full article >>

BioClinica: Why Supplies Matter

Tue, 19 Jan 2010 09:51:01 -0500

As posted on ClinPage's website:

What are the indispensable elements of an eclinical suite? What are the obligatory applications that any well-managed clinical trial will depend upon? Yes, electronic data capture (EDC). What about imaging? And ... drum roll, please ... drug supplies?

Such questions are a bit more urgent in the wake of BioClinica buying two companies this month.

One purchased firm, CardioNow, extends BioClinica's existing offerings as an imaging core lab, adding the ability to move large numbers of medical images. CardioNow specializes in transporting huge DICOM files.

BioClinica expects CardioNow to let it sell a more complete, end-to-end control of radiology studies for research, from the acquisition of the picture to its archiving. "We can start saving people money and giving them better response times in the next two months," BioClinica president and CEO Mark Weinstein says.

Supplies = Sexy?

Indeed, when the imaging files are hundreds of megabytes in size, and it's necessary to move thousands of them a week, email attachments won't cut it. Serious systems and networking are needed, especially since CardioNow had 500 institutions using its technology for cardiovascular research.

The other acquired firm, Tourtellotte Consulting, randomizes patients over the phone and the internet. It can handle the tasks of any interactive voice response system (IVR). But the company can also simulate and manage drug supplies. That's more unusual. (ClinPage wrote about Tourtellotte in this story last year.)

While many vendors and contract research organizations offer randomization, it is rare to have deep expertise in automating mid-study supply changes. One needs biostatistical chops and logistical knowledge to ensure that trials don't run out of medicine or bankrupt their sponsors by manufacturing vastly more drug than is actually needed.

Adaptive Angle

Advanced drug supply management, in short, could be a major differentiating factor—something that puts BioClinica in contention for eclinical projects of every level of scale and difficulty. Weinstein and his systems are ready for adaptive trial designs, but he believes most firms in the industry will first explore approaches with less regulatory risk.

Medical device trials, because of compressed time lines and large numbers of patients, may present a more immediate and significant opportunity for BioClinica, given its prowess in imaging and a more seamless eclinical suite than competitors. It sounds like a new device-oriented product could be in development at BioClinica.

One unknown complication, at this stage, is the speed and skill with which BioClinica will be able to combine its recent purchases (which include Phoenix Data Systems). The race to build bigger, more comprehensive systems is on, and it is no longer one in which small companies can prevail.

One of Weinstein's competitors (Phase Forward) recently bought not one but two IVR systems. Another rival (the IT unit of Parexel) has deep experience in imaging, IVR and data integration. The contract research organization inside United Health Group, finally, just built an eclinical system from scratch. When sauropods like these bump their chests together, smaller beings should simply take cover and wait for the ground to stop moving.

Weinstein is not cowed by his fellow mega-dinosaurs. After all, one of them lacks both an IVR and an imaging solution. "We can accelerate the growth of these various pieces," he says. "We are very, very interested in interesting technologies and even more interested in the people that come with them and the clients they serve."

Attaining Scale

Weinstein says that with almost 500 employees and $70 million in annual revenues, BioClinica is now large enough to shoulder the call desks, data centers and other infrastructure that is critical to support a demanding sponsor community. "As we add pieces, we can get more efficient," he says. "If I was a small player, I would be concerned about getting the critical mass to be competitive."

Some of BioClinica's resources may have been useful in this week's acquisition of Tourtellotte Consulting. Tourtellotte had several big pharma customers, but one goliath owned an IVR system that Tourtellottte built and serviced. That strategy, says founder Ed Tourtellotte, left him with fewer resources—especially to develop software—than he might have liked.

Even so, the company managed to support 150 trials a year and to develop unique technology to both simulate supply needs in virtual trials—and manage randomization and drug supplies in actual studies. As far as we know, no other firm offers a similar product suite that can be given to customers for both simulating and managing randomization and drug supplies. Similar services exist in an outsourcing mode, but are typically run by academics or biostatisticians outside the sponsor's environment.

Real ROI

BioClinica, in contrast, will continue to refine the Tourtellotte products. Then it will offer them to sponsor firms of all sizes and budgets. What seems to have caught Weinstein's eye about Tourtellotte is its potential to reach a much broader swath of the industry, which currently may not have affordable, easy-to-implement drug-supply management tools.

Such software, Weinstein says, can provide an excellent return on a sponsor's investment—one larger than just using systems for the mundane collection of clinical data.

The possible savings, Weinstein says, may be as high as 20-30 percent of the budget allotted for drug supplies. "It's hard to find another part of research where you can save that kind of money for your clients," he says of drug supply management. "That is worth an amazing amount of money to the sponsor."

Avoiding Outages

Ed Tourtellotte agrees: "It's not so much saving the money, which you surely do, but saving the trial. Boy, is it worth it not to have the trial halt or an emergency mitigation in the middle of the trial."

Tourtellotte recalls that as recently as 2006, simulation was still novel, still unusual. "Now, people come up and say, 'We need that,' " he says. Asked to guess the extent of trial and drug supply simulation in 2016, Tourtellotte ventures that it may be ubiquitous by then.

For now, elsewhere in the landscape of technology and outsourcing suppliers, some telephone-based randomization systems are hard to connect to the systems that assign and track shipments of drugs to depots and sites. It will be interesting to see if technology firms, service firms or both develop similar capabilities.

Integrated Offering

One of Tourtellotte's most prized systems—Trident—allows ordinary humans, not programmers, to set up randomization. Avoiding programmers, he says, saves money and adds speed and flexibility to the trial start-up process. Once a Trident simulation is complete, the randomization is ready in minutes, not the weeks or months that other IVR suppliers may need.

The new IVR technology from the Tourtellotte purchase, Weinstein says, will slowly supplant the company's existing technology in new projects. Ongoing trials, needless to say, will be fully supported on older systems.

But in general, BioClinica is hoping that its old and new bits of software will help it offer something rare under the clinical sun: agility. In theory, agility could be especially irresistible to cash-constrained small and mid-sized pharmas that, unlike the most mammoth firms in the industry, live within tight budgets.

Small- and mid-sized sponsors, Weinstein says, already grasp the value of integrated solutions like BioClinica's, especially when the package includes a few cutting-edge tools of the type that Tourtellotte and CardioNow have been offering. Says Weinstein: "More and more development will be done by the small and medium-sized guys. We have the advantage to be able to give the small to medium-size guy something he has not had access to. We think that will be well received."

Click here to read the full article >>

BioClinica Buys Tourtellotte in Busy Acquisition Month

Wed, 30 Sep 2009 18:02:52 -0400

As posted on Outsourcing-Pharma.com:

By Nick Taylor, 17-Sep-2009

BioClinica is continuing to acquire companies in the wake of the collapse of its etrials bid, buying software and services provider Tourtellotte Solutions just over two weeks after its last takeover.

In May BioClinica was poised to buy etrials but its bid collapsed and in June Merge Healthcare made the acquisition. Since then BioClinica has moved quickly to expand its business, buying CardioNow at the start of September and now acquiring Tourtellotte.

The purchase of US-based Tourtellotte expands BioClinica's eClinical offering by adding tcVisualise, supply chain simulation software, and interactive voice and web response technology (IXR).

By making these additions BioClinica believes it can "improve the overall clinical trial process" of its clients by adding products that can increase efficiencies. One of these products is tcVisualise which helps study managers "develop the perfect clinical supply plan".

The software is used by four of the top 10 global pharma companies, according to BioClinica, which use it to reduce product waste, trial delays and lost patient enrollment due to product stockouts.

In addition BioClinica adds Trident to its portfolio by acquiring Tourtellotte. Trident is an IXR that can help clients remotely manage all aspects of trials including patient screening, enrollment, randomisation and distribution.

BioClinica believes this is the next-generation of IXR and that it redefines how the technology can be used by the biotech industry. The system has been built specifically for the web and consequently is free from the issues that are present in retrofitted software.

Earlier buy

The acquisition of Tourtellotte by BioClinica follows on from its takeover of CardioNow. BioClinica acquired CardioNow from Agfa HealthCare to improve its ability to share, track and archive medical images from multi-centre clinical trials.

Following the acquisition BioClinica has begun integrating CardioNow's technology into its electronic data capture (EDC) system, a process that the company said would take up to 45 days from September 1.

Once this process is complete BioClinica said it will offer clients immediate cost savings on each of the 200 clinical trials it is currently supporting.

Click here to read the full article >>

BioClinica Acquires Tourtellotte Solutions

Wed, 16 Sep 2009 09:51:23 -0400

NEWTOWN, PA, September 16, 2009 – BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced that it has acquired privately-held Tourtellotte Solutions, Inc. (Tourtellotte), a leader in software and services for the bio-pharmaceutical industry.

BioClinica Acquires CardioNow from AGFA Healthcare

Tue, 01 Sep 2009 10:19:51 -0400

NEWTOWN, PA, September 1, 2009 - BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced that it has acquired the CardioNow unit of Agfa HealthCare. With this addition, BioClinica now offers streamlined electronic transport solutions to facilitate the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as part of its suite of imaging services. Imaging information will also be integrated with BioClinica Express electronic data capture to further simplify and enhance the clinical trial process for life science companies.

In Search of Paperless Clinical Trials

Mon, 10 Aug 2009 14:48:32 -0400

As published in the AIIM > Infonomics Magazine

These Critical Scientific Endeavors Bring Us Better, Safer Drugs. But Are We Close to Killing Their Mad Lust for Trees?

The use of formal clinical trials for testing medical drugs was first documented by the Persian physician and scientist Avicenna in 1025 AD, but he would probably not recognize his invention today. The modern clinical trial involves the careful coordination of activities among the study sponsor, clinical investigators, Internal Review Boards (IRBs), Contract Research Organizations (CROs) and possibly others; the collection of enormous amounts of data; and of course, paper...lots of it.

The mountains of paper involved represent more than a cost to the environment; for the drug companies that sponsor the studies, they represent enormous expenses associated with managing it. The records management team at one pharmaceutical company estimates their cost just to manage and maintain paper records at $1.25 per page. And that does not include the initial printing, copying, and distributing costs, just the management of the record after the trial. With many studies generating more than 10,000 documents, the potential savings from paper reduction is substantial.

Over the last 20 years, all kinds of computer technology has been incorporated into the clinical study process, often accompanied by a vision of a "paperless" clinical trial at some future date. Clearly, that future date has not arrived yet. But technology clearly has changed the study process dramatically, and in fact has replaced many paper-based processes. So where are we in the quest for the mythical paperless trial? Have there been any sightings? Are there any encouraging signs that we may be closing in?

Clinical trial management systems address the process-not the paper

Clinical Trial Management Systems (CTMS) have been one focal point for the use of computer technology in clinical trials. These systems are used to plan and manage the entire clinical trial, including site identification, patient recruitment, project budgeting, and tracking due dates and activities.

But while clinical trial management systems enable study managers to better address the enormous complexity of the clinical trial process, they do little to reduce the amount of paper actually generated by the study activities. You could even make the case that clinical trial management systems make it possible to manage more complex studies, which result in ever more paper.

To really replace paper, you need to automate the activities that are at the center of the trial process. And nothing is more at the heart of a clinical trial than collecting information about how each patient participating in the trial is reacting to the medication being tested.

The impact of electronic data capture and acquisition

Electronic Data Capture (known in the industry as EDC) solutions have had the biggest impact on the way paper is used in clinical trials. EDC solutions focus on the assembly, organization, and verification of clinical data and the preparation of case report forms. Along with "Electronic Data Acquisition" technologies such as interactive voice response (telephone-based collection of information from patients) and wearable monitors, the growth in adoption of EDC technologies has had a dramatic impact on how clinical studies are done, and how much paper is involved.

According to Carol Smith, director of Clinical Documentation at Cephalon (see related story on page 26), one of the world's top 10 biopharmaceutical companies headquartered in Frazer, Pa., "of all the technologies we have adopted, EDC technologies have had by far the biggest impact on reducing the amount of paper involved in clinical trials. And it is not just the collection of the data; it is the compilation and preparation of Case Report Forms, which includes all the data on each participating patient at each site."

So, with the widespread and growing use of EDC, are we on the brink of the paperless trial? Not even close, as it turns out. That's because, according to Smith and her colleague Mark Carroll, a director in the IT organization at Cephalon, the gains from EDC have been significantly offset by increases in reporting requirements mandated by the FDA.

Two steps forward, one step back

Between the two of them, Smith and Carroll have well over 20 years of experience supporting clinical research. And in that time, they have seen substantial increases in the regulatory requirements for documentation throughout the trial process. The area where reporting requirements have expanded the most is in the area of adverse drug reactions, also known as pharmacovigilence. Reporting requirements relating to adverse affects have increased substantially in the past decade, with more reports and forms driving an increase in paper. And according to Carroll at Cephalon, "two steps forward, one step back has been the pattern when it comes to reducing paper in the clinical trial process through paper. I feel like we have been playing "Whack-a-Mole" in that, for example, when we went after case report forms, other areas ballooned."

So there is still a lot of paper involved today. One reason for that, in addition to increasing regulatory requirements, is that most of the technology applied to the clinical trial process has bypassed one of the biggest tree-killers of all, the Trial Master File (TMF).

Next up: the Trial Master File-what does it accomplish?

The Trial Master File (TMF) includes all the regulatory documents required for a clinical trial, including what are sometimes called the "essential study documents". Traditionally kept as a set of binders, they include a wide range of document types ranging from medical and scientific curricula vitae to investigator brochures, study protocols, and informed consent forms. And there can be many, many documents of each type, resulting in a total collection of thousands and thousands of documents in each TMF.

Despite all the technology applied to automating various aspects of clinical trials, the TMF is not often a target of these efforts. The focus to date has been more on the data than on the documents, probably because automating data-intensive processes is far easier than document-based processes. But it could be that moving to an electronic Trial Master File (eTMF) will be the key to the goal of reducing paper.

According to Carroll at Cephalon, there is "huge potential for paper reduction by moving to an electronic trial master file. And huge savings." The biggest reason for that is that by having a single electronic copy that all the study participants can access, there is a dramatic reduction in the need to print, distribute, and store multiple copies at different sites.

For example, any time there are multiple copies of a document in existence, they need to be carefully managed and reviewed to ensure perfect accuracy between them. And at most companies, study documents are burned to CDs or flash devices along the way as part of their standard operating procedures.

Clearly, if there could be a single electronic copy of the clinical trial master file available to all study participants across all sites, the savings in paper and money would be substantial. So why aren't we there yet?

Challenges to implementing Electronic Trial Master Files

According to Peter Benton, president of the eClinical Services Division of BioClinica (formerly Phoenix Data Systems), based in Newtown, Pa., the challenges relate to processes more than technology. His company provides the pharmaceutical and biotechnology industries with a comprehensive array of clinical data solutions, including full-service EDC.

In regard to the impact of EDCs, the preparation of clinical report forms and data analysis, Benton agrees with Carroll and Smith that there has been a dramatic impact from technology. He notes that these technologies all focus on the data, not the documents. When it comes to essential study documents, however, Benton feels that "going electronic requires getting control of your processes. You can't use your paper processes to operate an automated system."

Smith at Cephalon agrees that the challenge to implementing an electronic trial master file relates to people and processes, not technology. "The key obstacle is the resistance to change among individuals, especially in the actual clinics and doctors' offices. Getting the technology into those settings and driving adoption requires a serious focus on change management and training to ensure effective adoption."

While changing processes surrounding study documents may be the biggest challenge to moving to an automated trial master file, addressing that challenge may provide the biggest payoff of all. According to Benton at BioClinica, "The move to electronic documents will pay off in a big way, because the documents in a clinical study act as the punctuation marks to the whole process. If we can accelerate the production, review, approval, and submission of those documents, we accelerate the entire process."

Whither extinction of the pulpwood vampire?

So despite the challenges, both Cephalon and BioClinica are pressing forward with initiatives focused on deploying automated systems for managing essential study documents and connecting study sites, investigators and managers. Both companies are in the process of implementing NextDocs' Clinical Documents Module and related solutions, with a focus on using them to manage the regulated clinical study documents.

The NextDocs solution includes a complete set of document types, taxonomies, and metadata collections for managing eTMF documents as well as a portal to facilitate collaboration of study participants working from multiple environments in a secure extranet collaboration environment. And, more importantly for any drug development company, it includes all the features necessary to address the U.S. Food and Drug Administration's (FDA) requirements for managing controlled content, referred to in the industry as FDA 21 CFR Part 11.

Given the history of automating efforts in clinical studies, it may seem like this next effort to reduce paper is just another battle in a war that cannot be won. After all, according to Carroll at Cephalon, "The question is, if we get this under control, what else will come up?"

His perspective indicates that no one is expecting a truly paperless clinical trial any time soon. Nonetheless, companies like Cephalon and BioClinica are committed to moving forward with their initiative, connecting study sites and participants to a single, central, clinical trial master file. While it may not eliminate all the paper, the benefits in terms of dollar savings, reduced risks related to documentation errors, and-most importantly-accelerating the time-to-market for new drugs simply demand it.

Ken Lownie is vice president of Life Sciences at NextDocs Corporation. He is a frequent speaker and author on the adoption of content management technologies in life sciences companies. Visit www.nextdocs.com for more information.

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BioClinica™ Announces Second Quarter 2009 Financial Results

Tue, 04 Aug 2009 22:32:54 -0400

NEWTOWN, PA, August 4, 2009 - BioClinica, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, today announced its financial results for the quarter and six months ended June 30, 2009. The operating results of Phoenix Data Systems ("PDS"), as a result of the acquisition completed March 24, 2008, are included in the second quarter 2008 financial results but are excluded from the first quarter 2008 financial results. The CapMed division, which was sold on January 6, 2009, was reclassified as a discontinued operation for all periods presented.

BioClinica, Inc. to Present at BMO Capital Markets Focus on Healthcare Conference on August 5, 2009

Thu, 30 Jul 2009 13:23:44 -0400

NEWTOWN, PA, July 30, 2009 - BioClinica, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, will be presenting at the BMO Capital Markets Focus on Healthcare Conference on August 5, 2009 at 3:30 p.m. EDT at the Millennium Broadway Hotel in New York City.

Mark L. Weinstein, President and CEO will be discussing an overview of BioClinica, Inc., its recent rebranding and strengthening of its robust suite of clinical trial services. BioClinica's shareholders earlier this month approved the Company's name change from Bio-Imaging Technologies, Inc.

The presentation will be simultaneously webcast and can be accessed at the following link: http://www.bmocm.com/conferences/2009healthcare/webcast/. Once you have accessed the link you will be provided specific instructions on how to connect to the BioClinica presentation.

BioClinica, Inc. to Release Second Quarter 2009 Financial Results on August 4, 2009

Tue, 28 Jul 2009 14:31:41 -0400

NEWTOWN, PA, July 28, 2009 -- BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the second quarter 2009 ended June 30, 2009, on August 4, 2009 after the close of the market, and will host a conference call on Wednesday, August 5, 2009 at 8:30 a.m. EDT to discuss the results of the quarter.

Those who wish to participate in the conference call may telephone 888-335-6674 from the U.S.; international callers may telephone 973-321-1100, approximately 15 minutes before the call. The conference ID# for both numbers is 21827243. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call's completion for two weeks, and may be accessed by dialing 800-642-1687 from the U.S. or 706-645-9291 for international callers, conference ID# 21827243. The replay will also be on the website under "Investor Relations" at www.bioclinica.com/investors for two weeks.

Bio-Imaging Technologies, Inc. Shareholders Approve Company's Name Change to BioClinica, Inc.

Wed, 08 Jul 2009 16:08:34 -0400

NEWTOWN, PA, July 8, 2009 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI), a global provider of clinical trial services, has received shareholder approval to change its name to BioClinica, Inc., effective immediately. In conjunction with this name change, the Company's stock symbol will change to "BIOC" at the commencement of trading on Monday, July 13, 2009, and will continue to trade on the NASDAQ Global Market and its CUSIP number will change to 09071B 100.

-Stock Symbol to Change to "BIOC" Effective July 13, 2009-

Best DIA Exhibitors

Mon, 06 Jul 2009 12:19:00 -0400

As posted on ClinPage's website:

Brad Pitt and Angelina Jolie care about drug development? They suddenly hunger to learn more about sponsor-CRO partnerships, PDUFA and Critical Path, and thus they showed up at the Drug Information Association's (DIA) 45th annual meeting to drink it all in? They are curious about science in addition to being gorgeous, rich and fertile?

Wait-those were actually Brad and Angelina impersonators at the BioClinica booth at DIA. But they looked so authentic! He sported glossy, tan skin and a tweed cap. She had big lips, long brown tresses cinched back tight, and huge sunglasses. Facial features on both were almost dead on. Brad (actually Ryan) and Angie (actually Tatiana) were Hollywood aloof yet exhibit-floor accommodating as they hung out in the BioClinica booth letting "paparazzi" take pictures of them with giggling passersby.

Brangelina Buzz

Ersatz Brangelina created the biggest scene we saw on the exhibitor floor at DIA, and thus BioClinica gets top prize from us this year: Best Exhibit Floor Buzz Generator.

Jim Dorsey, BioClinica's VP of marketing, was delighted with the attention at the booth. The theme, he told us, was Hollywood Premiere, and intended to reflect the April debut of BioClinica, the company's new brand name after the purchase of electronic data capture firm Phoenix Data Systems by Bio-Imaging Technologies. Photos of the attendees with Brad and Angelina are on the company's website, where a contest is also under way.

Click here to read the full article >>

BioClinica’S Jonathan Andrus Named Chair of DIA’S eClinical SIAC

Tue, 23 Jun 2009 19:29:03 -0400

SAN DIEGO, CA, June 23, 2009 - Bio-Imaging Technologies, Inc., (NASDAQ: BITI) d/b/a BioClinica a leading global provider of clinical trial services, announced today that Jonathan Andrus, Vice President, Clinical Data Management & Regulatory Operations at BioClinica's eClinical Service Division, has been elected as the Drug Information Association (DIA) North American Special Interest Area Communities (SIAC) eClinical Chair. Jonathan Andrus'

BioClinica’s Express Platform Receives CDISC Certification

Mon, 22 Jun 2009 20:55:30 -0400

SAN DIEGO, CA, June 22, 2009 - Bio-Imaging Technologies, Inc., (NASDAQ: BITI) d/b/a BioClinica, a leading global provider of clinical trial services, today announced that its Express EDC platform has been certified by the Clinical Data Interchange Standard Consortium (CDISC) as complying with the Operational Data Model (ODM) standard.

Microsoft Announces Winners of the 2009 Pharmaceutical and Life Sciences Innovation Awards

Fri, 02 Apr 2010 11:59:00 -0400

Awards recognize best-in-class, Microsoft-based solutions in discovery and product innovation, sales and marketing, and clinical development.

San Diego, CA - June 22, 2009

Microsoft Corp. today announced winners of the 2009 Microsoft Pharmaceutical and Life Sciences Innovation Awards, honoring companies that have made the most innovative use of Microsoft-based solutions for breakthroughs in business processes and practices throughout the pharmaceutical and life sciences industry.

Announced at the Drug Information Association’s (DIA) 45th annual meeting in San Diego, the awards were presented in the categories of discovery and product innovation, sales and marketing, and clinical development.

“The companies recognized are examples of innovators who have developed technology solutions to address the major issues impacting the pharmaceutical and life sciences industry today,” said Michael Naimoli, director of U.S. life sciences industry solutions at Microsoft. “By building upon the existing Microsoft software platform, this year’s winners demonstrated solutions that help streamline clinical trial and discovery processes to facilitate research and discovery, as well as improve the end user’s experience.”

Award Winners

Submissions for this year’s awards came from global life sciences corporations specializing in biotechnology, diagnostics, medical equipment and devices, pharmaceuticals, animal health, nutritional products, and consumer health products. The winners are the following:

Discovery and Product Innovation: HUNT Research Centre and Biobank

Norway-based HUNT Research Centre and Biobank hosts one of the largest population-based health studies ever performed, consisting of three separate studies that span nearly 25 years and evaluate the same patient population. The studies, initiated to support epidemiological, clinical and preventive medical research, offer valuable insight into disease status and progression, particularly in relation to quality-of-life measures such as one’s environment, education and occupation. In preparation for the third study, HUNT Research Centre and Biobank recognized the need to deploy a technology to better manage and analyze real-time data.

HUNT Research Centre and Biobank implemented Thermo Scientific Nautilus Laboratory Information Management Systems (LIMS) to facilitate their ability to gather, store, manage, track and retrieve data securely, and yield real-time, dependable analysis and reports. Built on the Microsoft.NET Framework, Thermo Scientific Nautilus LIMS™ with the use of Visual Studio has enabled HUNT Research Centre and Biobank to improve its efficiency and data reliability to better serve the research community.

Sales and Marketing: Bristol-Myers Squibb

Bristol-Myers Squibb Co. is a leading global biopharmaceutical company that develops innovative medicines to combat serious diseases, with the end goal of extending and improving human life. In order to address the increasing complexity of business and customer changes, Bristol-Myers Squibb UK realized that its old technology would no longer suffice.

Bristol-Myers Squibb UK deployed Data Intelligence’s Business Intelligence Solution, PharmaANALYTICS™, to manage all of the sales and marketing data sources for the entire U.K. organization. As a result, the Data Intelligence SQL Server-based solution has enabled the staff to quickly respond to new business challenges and opportunities. In addition, over 200 sales representatives now have immediate access to their sales performance by account.

Clinical Development: Harvard Clinical Research Institute

The Harvard Clinical Research Institute advances research by facilitating more efficient collaboration between the industry and academia. A highly respected academic research organization (ARO) the Harvard Clinical Research Institute needed to aggregate data from multiple sources into one to generate increased efficiency and productivity. The Harvard Clinical Research Institute will make more information available to study constituents and respond more capably to a growing number of research centers around the world.

The Harvard Clinical Research Institute deployed TranSenda’s Office-Smart Clinical Trial Manager (OSCTM) in order to access critical operational data from disparate systems and multiple clinical trials, and manage it into a single source. The deployment of OSCTM, with its native interoperability with the Microsoft Office SharePoint System, resulted in a streamlined processing of operational data management, significantly reducing the amount of time and effort involved in each study. The Harvard Clinical Research Institute has also reduced overall costs for the overhead of data collection and retrieval.

The 2009 Pharmaceutical and Life Sciences Innovation Award winners were selected by an esteemed panel of industry experts:

Scott Lundstrom, research vice president, Health Industry Insights, an IDC Company
James Averback, president, Life Science Integration Partners
Benjamin Rooks, principal, ST Advisors LLC
Salvatore Salamone, senior contributing editor, Bio-IT World

More information about the 2009 Pharmaceutical and Life Science Innovation Awards can be found at http://www.microsoft.com/industry/healthcare/lifesciences/innovationawards.mspx.

About Microsoft in Health

Microsoft is committed to improving health around the world through software innovation. Over the past 12 years, Microsoft has steadily increased its investments in health, with a focus on addressing the challenges of health providers, health and social services organizations, payers, consumers, and life sciences companies worldwide. Microsoft closely collaborates with a broad ecosystem of partners and develops its own powerful health solutions, such as Amalga and HealthVault. Together, Microsoft and its industry partners are working to advance a vision of unifying health information and making it more readily available, ensuring the best quality of life and affordable care for everyone.

About Microsoft

Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.

For more information, press only:
Ted Ladd, Microsoft, (646) 225-4722, tedladd@microsoft.com

Caitlin McCabe, Ruder Finn, (212) 593-5812, mccabec@ruderfinn.com

Note to editors: If you are interested in viewing additional information on Microsoft, please visit the Microsoft Web page at http://www.microsoft.com/presspass on Microsoft’s corporate information pages. Web links, telephone numbers and titles were correct at time of publication, but may since have changed. For additional assistance, journalists and analysts may contact Microsoft’s Rapid Response Team or other appropriate contacts listed at http://www.microsoft.com/presspass/contactpr.mspx.

BioClinica Advances Standards Support at DIA 2009

Fri, 19 Jun 2009 18:32:35 -0400

NEWTOWN, PA, June 19, 2009 - Bio-Imaging Technologies, Inc., (NASDAQ: BITI) d/b/a BioClinica, a global provider of clinical trial services with more than two decades of experience and a thorough understanding of standards, is challenging the industry to increase standards implementation for clinical trials at the Drug Information Association (DIA) 45th Annual Meeting on June 21-25 in San Diego (booth #315). Standards support has quickly become a key focus for the life science industry to streamline the clinical trial process and reduce costs. However, the complexity of the task and the resource requirements put implementing standards on the ‘someday list' for many companies.

New Software to Improve Clinical Trial Performance

Fri, 02 Apr 2010 11:53:19 -0400

TranSenda developing "Cortex" performance management system

Bellevue, WA - June 18, 2009

TranSenda International, LLC announced today that it is developing a new solution, Cortex, designed to improve an organization's ability to manage a clinical trial's performance. Based upon patent-pending ClinBUS® data interchange technology already in use in TranSenda's Office-Smart solutions, Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies. For years the industry has struggled with an increasingly fragmented environment of disconnected clinical applications, sites and partners. TranSenda's Cortex, with its proven ClinBUS technology, represents a breakthrough in managing and controlling studies within a common environment-independent of study data formats and clinical trial applications.

With the Cortex clinical trial management performance system, sponsors and Clinical Research Organizations (CROs) will benefit from real-time connectivity across complex partner networks and enterprise environments, delivering superior performance visibility for improved decision support and trial management. With this data now centralized, analysis is greatly enhanced because ClinBUS technology is optimized to make data available in Microsoft® Office SharePoint Server (MOSS). Previously hard-to-get-to operational data can now be easily controlled, communicated and coordinated between people and applications using MOSS.

Current industry practice relies on costly custom data connections between applications which are specific to each trial. By connecting all applications and all trials in a single information system, Cortex creates more efficient, cost-effective and sustainable access to important operational data. Cortex accomplishes this by standardizing the exchange of clinical trial management data and its semantics in a centralized server. Standardizing common operational data also facilitates interoperability between various clinical trial applications, including legacy Clinical Trial Management Systems (CTMS). Using ClinBUS data interchange technology, Cortex is also compatible with CDISC ODM data types.

Cortex is also designed to facilitate codeless customization by users with SharePoint® experience and by Microsoft Independent Software Vendors (ISVs). This feature enables the extension and customization of clinical processes at a fraction of the cost and time of conventional development environments. Cortex basically unleashes access to operational information across applications and trials and allows it to be used in Microsoft's powerful Office System for the creation of configurable dashboards, specialized reports, custom workflow and much more.

Not only does Cortex unleash operational information to allow organizations to transform it into valuable knowledge, Cortex also enables a new level of "centralized" study management. For example, imagine being able to create custom workflow that generates user alerts based upon any combination of changes in data from interconnected systems. This would greatly improve a sponsor's ability to respond quickly to prevent delays, unnecessary spending or regulatory non-compliance. An example of a centralized application that can take advantage of the Cortex environment is TranSenda's Office-Smart Clinical Payment Manager. Site payment information that works on operational data maintained in ClinBUS from diverse CTMS and EDC systems could be managed centrally, helping ensure bottom-line study cost accuracy and meeting upcoming regulatory requirements for disclosure of items of value to healthcare professionals. Site payment and alert management are just two of many centralized solutions that Cortex can support to help fine tune an organization's ability to effectively manage trials.

"Cortex is a unique solution that will address the challenges faced by clinical business partners who are trying to increase efficiency while working within an increasingly complex environment of geographical dispersion and disconnected software", said Robert Webber, TranSenda's President and CEO. "Working closely with Microsoft on our ClinBUS technology has given TranSenda the very latest software capabilities to uniquely address these challenges."

Value-added SharePoint web parts to assist with reporting study enrollment, subject completion, Case Report Form (CRF) progress, and clinical site payment tracking are also planned for the upcoming release. Commercial availability will be announced at a later date.

TranSenda & Harvard Clinical Research Institute Announce Office-Smart Deployment

Fri, 02 Apr 2010 11:47:41 -0400

HCRI Expands TranSenda Relationship

Bellevue, WA - June 16, 2009

TranSenda International, LLC, today announced the deployment of a clinical trial software solution for Harvard Clinical Research Institute (HCRI) that expands the products and services already under contract between the two parties. HCRI was seeking to continue the process of simplifying its existing systems to manage and monitor various spreadsheets, information and documents related to their clinical trials. To accomplish this, HCRI has migrated from initially using TranSenda's Clinical Trial Manager product to Office-Smart Clinical Trial ManagerTM and Office-Smart Clinical Payment ManagerTM. This subsequent deployment also included the purchase of ClinBUS ConnectorTM along with professional services to consolidate existing data sets into a single repository for clinical trial management and related operational data.

By adding Office-Smart solutions to its organization, HCRI can now take advantage of advanced capabilities that allow integration between Clinical Trial Manager and the Microsoft® Office System. Office-Smart solutions also use TranSenda's innovative ClinBUS® data interchange technology to make data available through Microsoft SharePoint Server. Among other advantages, ClinBUS enables the use of SharePoint data grids to connect Microsoft Excel spreadsheets and databases, including Microsoft Access, to Office-Smart solutions for data import or integration. With this new level of connectivity, HCRI can now use previously hard-to-get-to data for the creation of SharePoint websites and dashboards-and to make better use of their existing Microsoft Office tools, including Excel, Access, Outlook and Word.

In addition to consolidating Microsoft Excel spreadsheet data, HCRI will also be integrating Office-Smart Clinical Trial Manager with a number of Clinical Trial Data Management Systems, including industry-leading Electronic Data Capture (EDC) system(s) as well as their web-based learning management system. "Creating a single repository within Office-Smart Clinical Trial Manager will significantly help with the managing of what are now three independent processes supported by multiple systems," said Robert Leonard, Chief Information Officer at HCRI. "We also look forward to the fundamental improvements TranSenda's Office-Smart solutions can help bring to our clinical operations. Connecting our Microsoft Office tools to work in conjunction with our study software represents an important step toward simplifying our environment. Given the success we have had with TranSenda so far, we are confident that we are on the right path to a more advanced and efficient way to assist our sponsors and researchers managing clinical trials."

About TranSenda

TranSenda is committed to transforming the clinical trial software environment by delivering solutions that address the underserved need to improve the "business-process" side of clinical trial operations. With innovative Office-Smart clinical trial solutions, study professionals can take full advantage of the Microsoft Office System to create a more efficient workplace that unifies study software with the practical usefulness of Office productivity tools. TranSenda International, LLC is a Microsoft Gold Certified Partner headquartered in Bellevue, Washington, USA.

About Harvard Clinical Research Institute

HCRI is an academic research organization, established by the Harvard Medical School, Beth Israel Deaconess Medical Center and Partners HealthCare. The Institute provides an efficient integration of industry and academic resources for clinical research and development. It collaborates with associated academic researchers to offer expertise in a broad range of therapeutic areas including interventional cardiology in which it is a recognized leader. HCRI provides industry as well as academic researchers with a center for data collection, management and analysis that is fully compliant with regulatory standards. HCRI is a respected academic research organization (ARO) that also offers sponsors expert trial design, safety management and independent centralized clinical endpoint event adjudication.

HITSP Begins Harmonization Process for Use of Electronic Health Records in Clinical Research

Fri, 19 Jun 2009 18:52:22 -0400

HITSP Begins Harmonization Process for Use of Electronic Health Records in Clinical Research. Thirty-five leading organizations from the clinical research community have pledged support for new initiative.

Washington, DC, June 15, 2009: The Healthcare Information Technology Standards Panel (HITSP), a cooperative partnership between the public and private sectors that works to ensure the interoperability of electronic health records (EHRs) in the United States, has begun work to identify global standards to support "core research data element exchange," specifically, a common set of information that can readily be exchanged between EHRs and clinical research systems.

As administrator of HITSP, the American National Standards Institute (ANSI) appreciatively acknowledges thirty-five organizations that have contributed their financial support to make this work effort possible including BioClinica.

TranSenda Releases Office-Smart Clinical Trial Manager Version 2.0

Fri, 02 Apr 2010 11:31:20 -0400

New release expands functionality of industry's only Office-Smart CTMS

Bellevue, WA - June 11, 2009

TranSenda International, LLC, today announced the release of Office-Smart Clinical Trial Manager v2.0, the latest addition to TranSenda's line of Office-Smart clinical trial solutions designed to help organizations take full advantage of their familiar Microsoft® Office tools. The new version substantially expands the unique functionality offered by Office-Smart Clinical Trial Manager (OSCTM), providing study professionals with enhanced interconnectivity between a comprehensive Clinical Trial Management System (CTMS) and the Microsoft Office System environment.

TranSenda has also continued to introduce functionality in this release specifically designed to augment the usability of the Office system as a front-end for OSCTM for those study professionals who have limited needs to use core CTMS functionality, but still need access to the information contained within it. The integration between the OSCTM and the Microsoft Office environment that they use every day allows the continued use of a familiar system to access and manage a trial's operational data, assuring user adoption.

The release of OSCTM v2.0 represents a significant step forward in TranSenda's delivery of a next generation CTMS which enables unprecedented connectivity between people and data across trials, systems and regions. New features that TranSenda has included in the v2.0 release include: greatly expanding the bi-directional updates for information exchange between OSCTM and Microsoft Office SharePoint Server (MOSS) through use of ClinBUS®, TranSenda's advanced data interchange technology; the ability to create Microsoft's InfoPath forms and bind them to SharePoint lists, making the process of data collection and review much easier; capability to create ad-hoc events and case report form (CRF) pages, resulting in sleeker and deeper integration with electronic data capture applications; enhanced connectivity between global configuration settings and study-specific parameters; and ease-of-use improvements such as expanded identifier variables, advanced address handling and dedicated sign-in assistance. Additionally, OSCTM v2.0 supports the requirements of the ClinicalTrials.gov Protocol Registration System, allowing users to access all of the data needed to comply with the corresponding regulations with the push of a button.

"TranSenda is very pleased to announce the release of the second version of our Office-Smart Clinical Trial Manager solution," said Jeremiah Rehm, director of product management at TranSenda. "This essential upgrade improves upon what is already the only CTMS designed to work in concert with the Microsoft Office environment, and will allow our customers to take a step towards solving any CTMS adoption issue they may face by allowing their study professionals to work in the environment best suited to their needs".

Bio-Imaging Technologies and Etrials Worldwide Merger Agreement Terminated

Mon, 01 Jun 2009 16:01:35 -0400

NEWTOWN, PA, June 1, 2009 - Bio-Imaging Technologies, Inc. (NASDAQ: BITI) (d/b/a "BioClinica") announces that, in response to another unsolicited offer received by etrials Worldwide, Inc. (NASDAQ: ETWC) ("etrials") from an unrelated third party, etrials has informed Bio-Imaging that its board of directors has deemed the unsolicited offer a superior proposal, as defined in the merger agreement between the parties, and has entered into a merger agreement with such unrelated third party.

Bio-Imaging Technologies D/B/A BioClinica To Participate in Leading Industry Conferences.

Wed, 27 May 2009 13:04:41 -0400

NEWTOWN, PA, May 27, 2009 - Bio-Imaging Technologies, Inc., (NASDAQ: BITI) d/b/a BioClinica, a leading global provider of clinical trials services, helping to support drug and product development efforts through all phases of the clinical trial process, will participate in and present at several key industry conferences during the months of May, June and July, as part of its ongoing marketing program.

Bio-Imaging Technologies Increases Its Offer to Acquire ETrials Worldwide

Wed, 20 May 2009 15:35:18 -0400

NEWTOWN, PA / MORRISVILLE, NC, May 20, 2009 - Bio-Imaging Technologies, Inc. (NASDAQ: BITI)(d/b/a "BioClinica") and etrials Worldwide, Inc. (NASDAQ: ETWC) ("etrials") jointly announce that, in response to an unsolicited offer received by etrials from an unrelated third party, the parties have executed an amended merger agreement, increasing the value of the offer.

Bio-Imaging Technologies, Inc. d/b/a BioClinica™ Announces First Quarter 2009 Financial Results

Wed, 06 May 2009 12:49:30 -0400

NEWTOWN, PA, May 6, 2009 -Bio-Imaging Technologies, Inc. (NASDAQ: BITI), d/b/a BioClinica, a global provider of clinical trial services, today announced its financial results for the quarter ending March 31, 2009. The operating results of Phoenix Data Systems ("PDS"), as a result of the acquisition completed March 24, 2008, are included in the first quarter 2009 financial results but are excluded from the first quarter 2008 financial results. The CapMed division, which was sold on January 6, 2009, was reclassified as a discontinued operation for all periods presented.

Bio-Imaging Technologies to Acquire Etrials Worldwide

Tue, 05 May 2009 13:13:21 -0400

Acquisition Expands Electronic Data Capture (EDC), Interactive Voice and Web Response Technology (IWR/IRT), and Electronic Patient Reported Outcome (ePRO) Capabilities, and Broadens Customer Base

NEWTOWN, PA / MORRISVILLE, NC, May 5, 2009 - Bio-Imaging Technologies, Inc. (NASDAQ: BITI) (d/b/a "BioClinica”) and etrials Worldwide, Inc. (NASDAQ: ETWC) (“etrials”) jointly announce Bio-Imaging’s intent to acquire etrials. The proposed acquisition is expected to be consummated through a tender offer for all of the outstanding shares of etrials stock.

Bio-Imaging Technologies, INC. D/B/A BioClinica to Release First Quarter 2009 Financial Results and Host Conference Call on May 6. 2009

Wed, 29 Apr 2009 15:16:03 -0400

NEWTOWN, PA, April 29, 2009 -- Bio-Imaging Technologies, Inc.(the “Company”) (NASDAQ: BITI) d/b/a BioClinica announced today it will release its financial results for the first quarter ended March 31, 2009 on Wednesday, May 6, 2009.

Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EDT to discuss the Company’s financial results and achievements.

Listen in to the live call:

Bio-Imaging Technologies and Phoenix Data Systems Unify Service Offerings as BioClinica™

Tue, 28 Apr 2009 14:59:25 -0400

Integrated EDC and Imaging Core Lab Services Improve Efficiency, Quality and Data Visibility for Life Science Companies

ORLANDO, FL, April 28, 2009 - Bio-Imaging Technologies, Inc. (NASDAQ: BITI) and its Phoenix Data Systems division today announced that they are re-branding the two companies under the name of BioClinica (the "Company"), thereby completing the final stages of an operational merger that started a year ago. With a legacy of more than two decades of experience and industry leadership, BioClinica combines electronic data capture (EDC) services and medical image management to offer a single, integrated solution that increases efficiency and decreases costs for pharmaceutical, biotechnology and medical device companies through all stages of clinical trials. BioClinica, as well, continues to provide traditional EDC and imaging core lab services to its customers. The Company will be at CRO Partnerships, April 28-30 (booth 408), showcasing the capabilities of its integrated solution.

Development Automatic Classification of Vertebral Shape Based on Statistical Shape Modeling

Wed, 22 Apr 2009 18:50:06 -0400

Bio-Imaging Technologies Medical and Scientific Leaders Contribute to the poster presentation for Development Automatic Classification of Vertebral Shape Based on Statistical Shape Modeling at the National Osteoporosis Foundation on April 1-5, 2009 in Washington D.C.

Newtown, PA – April 21, 2009 – Bio-Imaging Technologies announced today that Colin G. Miller, Ph.D. F.I.C.R., Vice President of Business Development and Clinical Affairs, US, is a contributing author of an original article published with the American Medical Association in their Archives of General Psychiatry Publication in the February 2009 issue.

Objective

The purpose of this study was to test a classifier of vertebral fractures based on statistical shape modeling.

Methods

We previously described a method for annotation of vertebral shape using 95 points representing the circumferential vertebral borders on lateral spine x-rays (1), see Figures 1 and 2 below.
We used this method to manually annotate 2503 vertebrae on lateral thoracic and lumbar spine x-rays from 237 subjects. Independently, these films were read by an expert radiologist (CH) who classified each vertebra according to the Genant SQ scoring scheme and provided differential diagnosis for non-osteoporotic vertebral deformities. The image data was as follows: 2390 vertebrae were normal, 967 had non-osteoporotic deformities, and 113 were fractured: 44 fractures were mild (grade 1), 69 were definite (grade 2 or 3).
Using “leave-one-out” methodology we built two-class classifiers to classify all osteoporotic fractures vs non-fractures and specific grade osteoporotic fractures vs non-fractures.

Results

The results are presented in Table 1. Balanced error rate classifiers yielded equal sensitivity and specificity of 95.6% overall, 90.1% for mild fractures, and 97.4% for definite fractures with the area under ROC curve of 0.9872, 0.9712 and 0.9975 respectively. The Kappa Score between expert and classifier was 0.64 overall, 0.24 for mild (grade 1), and 0.69 for definite (grade 2 or 3) fractures.

Discussion

These initial results show that a classifier can be constructed to distinguish osteoporotic from normal or non-osteoporotic deformities with an agreement similar to or better than, results published previously for human observers. Our study showed high sensitivity and specificity to identification of osteoporotic fractures from a set of vertebrae that were either normal or deformed but not by osteoporotic fracture. Our training set was characterized by relatively few fractures and a high degree of non-osteoporotic deformities. Building the classifier based on films further enriched for vertebral fracture would likely improve its performance. Combining this classifier with an efficient annotation tool may provide a useful work flow tool in clinical trials or a decision-making aid in a point-of-care setting.

References

(1) Brett et al. In Proc ASBMR, W227, Hawaii, Sept 2007
Presented at the NATIONAL OSTEOPOROSIS FOUNDATION 8th International Symposium on Osteoporosis: Translating Research into Clinical Practice, Washington, DC, April 1-5, 2009.

TranSenda On Panel at BAYBIO Conference

Fri, 02 Apr 2010 11:26:48 -0400

BayBio2009 Annual Conference: Navigating the Storm

Bellevue, WA - April 6, 2009

TranSenda International, LLC, today announced its chief executive officer and president, Robert Webber, will participate as a panel speaker at BayBio's annual conference at the South San Francisco Conference Center in San Francisco, California on April 16, 2009. The BayBio2009 conference focuses on emerging technologies positioned to address today's and tomorrow's critical healthcare, manufacturing and environmental concerns, such as skyrocketing health care costs, worldwide food and fuel shortages, escalating manufacturing costs and global competitiveness.

TranSenda will participate in the session, Stretching the Clinical Dollar in Challenging Financial Times, scheduled for April 16, 2009 at 3:45pm PDT. A panel discussion, moderated by Laurie Halloran, president and chief executive officer of Halloran Consulting Group, will address various options and possible changes in development methodology that lead to tangible outcomes, such as lower costs or increased speed. Panel speakers include Connie Andrews, Director, Clinical Outsourcing, Exelixis Pharmaceuticals, Inc.; Bruno Gagnon, Senior Director, Clinical Operations, Roche Molecular Systems; Mari Maurer, Director, Clinical Operations, BioMarin Pharmaceutical Inc.; and May Yau, Director, Clinical Operations, CardioDx.

Several industry keynote speakers will address issues of importance to life sciences professionals. For more information about BayBio2009 visit the Events section on TranSenda's website.

Medical Imaging and Electronic Data Capture in Clinical Trials: the Future Paradigm

Wed, 22 Apr 2009 18:36:24 -0400

As Featured in the Spring 2009 issues of IPI
(International Pharmaceutical Industry) magazine:

Medical Imaging and Electronic Data Capture in Clinical Trials: the Future Paradigm.

Colin G. Miller, Ph.D., FICR, CSci SVP Medical Affairs, Bio-Imaging Technologies, Inc. Newtown, PA USA

All clinical trial data are ultimately digital. The pathway to this digital database is not always as connected as one might expect in this technological age. The backbone of clinical trials is now Electronic Data Capture (EDC), and this is not yet synchronous with the other major aspects of data collection, such as medical imaging. With the need for more streamlined processes, this paper explores the combination of medical imaging with EDC and provides the future paradigm for the trial list in the digital age. This will not only ensure an earlier final database lock, which is a key milestone, but during the trial data quality control (QC), and specifically image data QC, and evaluation can be performed in a more contemporaneous fashion with immediate feedback to those managing the study and the local investigator site. The ultimate goal is to unify all the essential data in a standardised format to expedite submissions and to increase the quality of those submissions.

Introduction

The use of medical imaging in clinical trials has seen an exponential growth in the last decade due to increased use of technology and improved computing power (1). This use continues to grow, particularly in early stage development when the latest techniques can aid in the early go/no-go decisions in new pharmaceutical/biotech product development. Examples of new techniques which are starting to be more commonly used in Phase I and II are listed in Table 1. For completeness, the more common applications that are used in Phase III are listed in Table 2, although the techniques are not exclusive to the phases listed.

The need for an imaging core lab (ICL) has been described elsewhere (2) and is now a standard part of the team of the vendors in clinical trials (3). The days of leaving the image interpretation and analysis to the local investigator site have long gone due to the loss of data, reduced precision and lack of standardisation. The local investigators’ radiological department’s work is optimised for image acquisition and image interpretation for patient management, but not for the safety and efficacy reads.

Along with the increased use of medical imaging in clinical trials, electronic data capture (EDC) has progressed significantly, so that in 2008 more than 50% of all trials used some form of EDC (4). The obvious question is raised about how to integrate the medical imaging and EDC into one system or process. This challenge is being addressed on many fronts. Historically the two processes have been managed independently, and the ICLs have been totally separate entities from the EDC companies.

“The information delivered by AG Mednet and others is not yet integrated with EDC systems, therefore the investigator site can provide information via the EDC system to the core lab about the incoming images”

The reason for this is twofold: 1. medical imaging is memory-, storage-, and transport-heavy, with some image files exceeding 10MegaBytes (MB) in size, and 2. the requirements in the radiology department are such that they either do not have access to the EDC system or the technologists do not have the knowledge to transfer the images to a system that takes them outside their institutional firewall. Convergence of the two processes is now starting to take place, although complete integration is highly unlikely for the immediate future due to the challenges mentioned. However we can anticipate some immediate developments and envision the full integration paradigm with the corresponding advances and improvements.

This paper will discuss the concept of maximising the value of combining EDC and medical imaging, the utilisation of the synchronicity and working with ICLs and an EDC vendor with the current technology. A brief exploration of the mid-term future potential will also be entertained.

Medical Imaging and Electronic Data Capture

In most hospitals or clinics, medical images are available in a digital format, and even plain X-rays are obtained using digital X-ray although there are still some centres supplying plain film X-rays. The more technically savvy investigational sites will have the ability to submit the images to the imaging core lab via new technology processes such as those developed by AG Mednet (5). Not only are the images being sent electronically, but the data transmission information is sent and the images are anonymised. While this does not seem unreasonable in the current environment, there are still logistical and technical issues with some investigator sites, even beyond the issue of those sites still using film. Furthermore, the initial cost of setting this service up will be more than remaining with the well tried and tested method of sending the images via courier.

Interestingly, using overnight courier services versus an electronic method only gains a few hours in the time of receipt of the images at the ICL, since many sites send their images at the end of the business day, regardless of which methodology is used. Therefore for the direct electronic transfer method the images will arrive at the end of the ICL’s working day and so will start being processed on the following work day. If the images are sent by courier they are routinely delivered by 10 or 11 am the following morning to the ICL, providing a net increase of time of delivery of less than four hours compared to the direct digital delivery system. However, there are additional advantages and disadvantages that have to be carefully considered with both methods; these are summarised in Table 3.

The information delivered by AG Mednet and others is not yet integrated with EDC systems, therefore the investigator site can provide information via the EDC system to the core lab about the incoming images. Also, many EDC systems are tied in with interactive voice response systems (IVRS). If these are set up correctly, the ICL can receive notification at patient screening or randomisation, alerting them to the fact that there are screening images inbound, and they can be ready for the required rapid turnaround for eligibility of this data.

Medical imaging endpoints are used primarily for efficacy, but are being used more for safety evaluation, e.g. bone density assessment in trials, like the ATAC study for breast cancer (6) or isotretinoin in acne (7). Medical imaging is also used as part of the eligibility criteria. The tie into EDC therefore becomes more critical, and the need for the ICL team and the EC team to discuss the trial data flow is important. It will no longer be acceptable to have these two groups working independently, since with the optimal logic built into the EDC, the imaging will take on a bigger role. EDC will capture the results of the patient management and safety reporting with adverse events. The results of the safety reads and possibly the efficacy reads will need to be entered to provide the comprehensive picture. EDC programming is not just a matter of entering the questions from the CRF but building a complete logic sequence to the data capture. If this is provided as a combined team, the correct logic sequence can be applied, ensuring that the principal investigators (PI) and study site coordinators can be “steered” through the process to ensure there is no missing data.

* Some older techniques require a “black box” to be installed and linked into the PACS system. This has been found to be unworkable at the site.

Furthermore the logic should prevent incorrect data being entered. The author has experienced this first-hand in a complex osteoporosis study where with some round table discussions, the logic and performance of the EDC was enhanced and reduced the data entry at the site, while capturing the same information.

The blinded reads that are conducted by the ICLs are, in most instances the two central radiologists (or readers, since they can also be rheumatologists, cardiologists etc) reading the images in isolation of all the data, with a third to adjudicate any differences (8). However, in oncology the readers need to know if the patient has had a resection or radiation therapy, depending on the study. This information should be available in real time to them via the EDC system. Many oncology reads often go on to a so-called “global assessment”. This is the process where a central oncologist will review the images with one radiologist and a set of clinical data that has been determined a priori. This provides a trial overview of the data and ensures there is complete congruity of the images and clinical data. Obviously the use of the EDC system makes this process much more seamless and the global assessment can potentially be captured in the EDC system. Historically these kinds of global assessments have been rate-limiting to the end of the study: the clinical data had to come into the data management department of the sponsor or the contract research organisation (CRO) and, once cleaned, shipped to the ICL for integrating into the read system. Only then could the final global read be conducted, often weeks or months after the last patient, last visit (LPLV) time point. With an integrated EDC system this process can be moved up to occur within days of LPLV and not slow down the data integration and database lock.

Another aspect that has been gaining ground is the development of Adaptive Clinical Trials. These can only work if EDC is being used. In some of the more complex versions even the imaging may change depending on the arm or the inclusion criteria. This requires a very close relationship between the EDC vendor and ICL in the setup stages to ensure everything is captured in the correct sequence.

As more imaging is used in Phase II, the cost-effectiveness of using the right EDC vendor to work with the ICL becomes increasingly important. Pressure on the pharmaceutical industry to develop process improvements at all levels has dramatically increased. Phase II studies are probably the last area to feel the pressure to compress timelines. EDC has formerly been seen as this cumbersome technology that requires months of programming and therefore not suitable to the Phase I/II environment. This is no longer the case and within an eight week lead time, EDC and imaging can be set up in an expeditious manner to provide clean and rapid data with the right partners.

The Future

As we conceptualise the future, combining a robust EDC platform with even some of the basic medical imaging technologies that are now being deployed will allow the image management to be built into the EDC component. The images can then be reviewed by the ICL and can be sent to the blinded read all within the same software platform. All the reads are then captured in the same EDC software platform. As we look into the future not only does this EDC synchronicity provide an elegant one-stop shop solution but it provides image data handling in the same environment as the other electronic data. Furthermore with proper planning and programming, the monitors and sponsor can have all this information in dashboard format providing advanced monitoring tools.

Conclusions

In the next 36 months or so, we can anticipate that medical images will be transferred electronically to the core lab as a de facto standard, and the courier will be relegated to the smaller investigator sites, new sites, or those sending X-rays. We can anticipate that those EDC vendors who are forward-thinking and linked in with ICLs will exploit the relationship and further improve the logic and questions in the EDC process. There will be a much closer tie-in with the IVRS and notifications to the ICL will result in a more rapid followup and knowledge of the incoming images. This will further reduce the losses of images that occur in clinical trials. The ultimate goal is to unify all the essential data in a standardised format, to expedite submissions, and to increase the quality of those submissions. With the advent of the eclinical space, over time, medical imaging will become a specialised extension of this rapidly growing technology, rather than a standalone facet.

Dr. Collin Miller SVP Medical Affairs at Bio-Imaging, heads up the scientific over-sight within the company & provides consulting on trials in the muscularskeletal arena. He has a gained a Fellowship of the ICR (UK) and has attained the UK recognition of a Chartered Scientist. Dr. Miller has written and co-authored over 40 scientific publications and is co-editor of the books “Clinical Trials in Osteoporosis,” and “Clinical Trials in Osteoarthritis and Rheumatoid Arthritis,” published by Springer Ltd.

References

1. Reiber H, van Kuijk C, Schwarz, L. Medical Imaging and its use in clinical trials. European Pharmaceutical Contractor Autumn 2005.p80-84

2. Miller CG, Noever K. “Taking care of your subject’s image: The role of Medical Imaging Core Laboratories” Good Clinical Practice Journal 2003, 10 (9) p 21-24

3. Miller CG. Medical Imaging Core Laboratories. Applied Clinical Trials October 2005

4. April 2007, Health Industry Insights #HI206351

5. www.bioimaging.com/overview/agmednet

6. Eastell R, Adams JE, Coleman RE et al. Effect of anastrozole on bone mineral density : 5 year results from the anastrzole, tamoxifen, alone or in combination trila 18233230. J Clin Oncol. 2008, Mar 1;26(7) 1051-7

7. DiGiovanna JJ, Langman CB, Tschen EH et al. Effect of a single course of isotretinoin therapy on bone mineral density in adolescent patients with severe, recalcitrant, nodular acne. Journal American Academy of Dermatology 2004, Volume 51, No 5. p709-717

8. Miller CG, Noever K. Reading Medical Images in oncology clinical trials. European Pharmaceutical Contractor 2004 Summer, p 95-100 32

Bio-Imaging Technologies Participates in Leading Industry Conferences - Also Sponsors Complimentary Symposium on CNS Imaging In Clinical Trials.

Sun, 26 Apr 2009 20:26:26 -0400

--Also Sponsors Complimentary Symposium On CNS Imaging In Clinical Trials--

NEWTOWN, PA, March 9, 2009 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI), a global provider of clinical trial services, will participate in and present at several key industry conferences during the months of March and April, as part of its ongoing marketing program.

Development of Novel Clinical Imaging Biomarkers

Wed, 22 Apr 2009 18:15:44 -0400

Bio-Imaging Technologies Medical and Scientific Leaders Contribute to Development of Novel Clinical Imaging Biomarkers to Elucidate Relationship of Type 1 Cannabinoid Receptor Availability in the Human Brain to Novelty-Seeking Temperament using PET technology which has been published in American Medical Association’s top-ranking journal Archives of General Psychiatry February 2009 issue.

Newtown, PA – February 28th, 2009 – Bio-Imaging Technologies announced today that Igor Grachev, MD, PhD, Vice President of Business Development and Clinical Affairs, US, is a contributing author of an original article published with the American Medical Association in their Archives of General Psychiatry Publication in the February 2009 issue.

Using PET Imaging and the Cloninger Temperament and Character Inventory (TCI) in 47 healthy subjects, standard uptake (SUV) images were coregistered to the subject’s MRI for regional analysis using statistical parametric mapping (SPM2). The objective of the study was to investigate whether there is a relationship between human temperament traits and regional cerebral CB1R availability. The results of the study showed that novelty seeking was inversely correlated with global CB1R availability with the most significant correlation in the left amygdale.

SPMaps showing inverse correlation of the novelty-seeking (extravagance)
with type 1 cannabinoid receptor availability (p<0.05, corrected for multiple comparisons)

The conclusion of the study showed that low baseline cerebral CB1R availability is related to a high novelty-seeking personality, in particular to extravagance, most pronounced in the amygdale. Further investigation of the functional role of the CB1R is warranted in pathological behavior known to be strongly related to novelty seeking, such as addiction and eating disorders.

Group comparison of average CB1 availability maps of 10 highest vs. 10 lowest scorers
on the novelty-seeking (extravagance) of the TCI. SUV indicates standardized uptake value.

Dr. Igor Grachev, MD, PhD, is Vice President of Business Development and Clinical Affairs, US at Bio-Imaging Technologies and former Senior Director at Merck. He has over 20 years of clinical trial experience in Academia and Pharmaceutical Industry.

Read the complete article.

About Bio-Imaging Technologies

Bio-Imaging Technologies is the world’s premier independent Imaging Core Lab (ICL). We manage all of the logistics to centralize your radiologic data and we provide expert independent review services for Phase I-IV clinical trials on a worldwide basis. BioClinica services include managing all aspects of radiologic data-from study start-up and initiation through data collection, quality control and processing; to expert independent blinded review and delivery of final results. Our deep roster of board-certified radiologists, oncologists, rheumatologists, cardiologists and other therapeutic and modality-specific professionals ensures that your trial receives the highest quality independent review.

Media Contact:
Jim Dorsey
Vice President of Marketing
Tel: 267-757-3000

NextDocs and TranSenda Partner to Offer Unified Document and Clinical Trial Management Systems

Fri, 02 Apr 2010 11:21:21 -0400

Companies' Solutions Built on the Microsoft Office System Provides a Natural Fit

Bellevue, WA - February 17, 2009

NextDocs Corporation and TranSenda International, LLC have entered into a collaborative agreement to integrate and cross-sell their solutions. Combining NextDocs' Microsoft Office SharePoint Server-based document management solutions with TranSenda's Office-Smart clinical trial management solutions creates a unified best-of-breed solution. Life sciences organizations will be able to take advantage of the seamless ways in which each company's solutions naturally complement one another due to their use of the Microsoft Office System.

The NextDocs product suite is an easy to use solution that is designed to enable organizations to comply with FDA 21 CFR Part 11, GMP, GLP, GCP and other regulations and industry standards. Built on the Microsoft Office SharePoint Server 2007 platform, NextDocs Document and Compliance Suite delivers a complete content management and collaboration system for managing documents, records (e.g. training records), SOPs (standard operating procedures), activities and other information critical to the enterprise. The Suite provides organizations with the ability to track, approve, and manage data in a secure and centralized repository without sacrificing usability and affordability. Seamlessly integrated with Microsoft Office, the NextDocs Document and Compliance Suite is fully web-enabled and can be securely accessed from any location.

"Our partnership with TranSenda is another important step toward providing invaluable document and quality management solutions for life sciences organizations," said NextDocs CEO Zikria Syed. "Together we can offer added-value to organizations engaged in clinical trials and ensure that we continue to provide the most intuitive and productive solutions in this industry."

TranSenda's Office-Smart Clinical Trial Manager^TM is unique in its ability to utilize the Microsoft Office System, creating a more efficient environment that unifies study software with the practical business-side of Office productivity tools. Office-Smart Clinical Trial Manager is a comprehensive system for setting up and administering clinical studies while delivering unparalleled flexibility and ease of use. Using TranSenda's Office-Smart solutions, study professionals can take advantage of their experience with their favorite Office tools like Excel and Outlook, as they benefit from a study environment of less work-not more.

"We believe it is critical that a next-generation clinical trial management system be open and able to connect with other systems," said Robert Webber, President and CEO of TranSenda. "But the NextDocs partnership goes beyond just connecting two disjointed systems. Our unique relationships with Microsoft means we can work together to deliver a deeper and more compelling value proposition for organizations looking to optimize the management of their clinical trial."
Both NextDocs and TranSenda have worked closely with Microsoft to ensure their solutions align with the company's technology and overall vision for life sciences.

"Given the turbulence in today's economy, and the pressure of pipeline productivity on the industry, life sciences firms are looking for ways to improve efficiency, save money and get products to market faster," said Michael Naimoli, U.S. life sciences industry solutions director, Microsoft Corp. "NextDocs' document management solutions and TranSenda's clinical trials management solutions, combined, provide a comprehensive offering for clinical trial and regulated document management- seamlessly integrated with Microsoft Office - that tackles these issues head-on."

About NextDocs

NextDocs is the leading provider of fully FDA 21 CFR Part 11 compliant Microsoft Office SharePoint Server-based document and quality management solutions for the life sciences companies. Our mission is to deliver cost effective, easy to use document management software which provides immediate productivity increases for companies operating in regulatory environments. NextDocs customers include Pharmaceutical companies, Bio-Techs, Medical Device companies and CROs. For more information please visit http://www.nextdocs.com

Bio-Imaging Technologies Announces Fourth Quarter and Year-End 2008 Financial Results.

Sun, 26 Apr 2009 20:30:48 -0400

NEWTOWN, PA, February 11, 2009 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI), a global provider of clinical trial services, today announced its financial results for the fourth quarter and year ended December 31, 2008. The results include the operating results of Phoenix Data Systems, Inc. (“PDS”), whose acquisition was completed on March 24, 2008.

Bio-Imaging Technologies to Present at the Roth 21st Annual OC Growth Stock Conference on February 16, 2009 at 3 PM PST.

Sun, 26 Apr 2009 20:33:23 -0400

Conference Being Held at The Ritz Carlton Laguna Niguel In Dana Point, CA, February 16-18, 2009

NEWTOWN, PA, February 9, 2009 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that its President and Chief Executive Officer, Mark L. Weinstein, will be presenting at the ROTH 21st Annual OC Growth Stock Conference at 3 PM PST on February 16, 2009.

Bio-Imaging Technologies to Release Fourth Quarter and 2008 Year End Financial Results and Host Conference Call on February 11, 2009.

Sun, 26 Apr 2009 20:35:24 -0400

NEWTOWN, PA, February 4, 2009 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI) will release its financial results for the fourth quarter and fiscal year ended December 31, 2008 on Wednesday, February 11, 2009. Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EST to discuss the company’s financial results and achievements.

Phoenix Data Systems – Giving Back

Thu, 09 Apr 2009 12:55:35 -0400

Special Feature - A Tough Test

www.pharmavoice.com

As Featured in the February 2009 issue of PharmaVOICE magazine –When Chris Connor’s tenacious dad, Jon Connor, was diagnosed with pancreatic cancer in the spring of 2005 he began a journey of self-discovery. At the time of his diagnosis it seemed almost impossible to all who knew Jon Connor that he wouldn’t beat it.

A tough fighter from South Boston and at the same time a caring, humble man, Jon Connor sadly succumbed to the disease 10 months after his diagnosis. “The cancer cells that eventually consumed his body were made of the same tenacious stuff that made my dad so tough,” Mr. Connor says. “In the end, he lost a fight with the only thing that could ever beat him: himself.”

Throughout his father’s illness, Mr. Connor had been by his side. As a healthcare proxy, he had access to his father’s medical records, and as a colleague of several of the doctors treating the senior Connor, he was also given an escorted institutional “hall-pass” and got to see firsthand the back office of the clinical research enterprise at a major academic medical center.

“I sat side-by-side with the radiologists as they read my dad’s CT scans,” Mr. Connor says. “I shadowed the study coordinators as they went back and forth from the pharmacy. I watched as they printed the labels for his sample vials. I visited the lab. I visited the infusion unit. And I visited the hospital's chapel."

On several occasions the elder Mr. Connor expressed concern that his son was spending too much time at the hospital. The younger Connor tried to explain to him that he really was working. His father would respond: "Well if you're working, then you should get back to your office." To which the son retorted that if he was so concerned about his cancer, then he should just get better and then he could go back to sitting behind his desk.

"I'd grimace and say 'you know dad, I really don't need your help," Mr. Connor says, "I'm smart enough to do my job on my own." But he never took me up on my offer. Ultimately, my dad succumbed to his disease, and I was forced to graduate from my ethnographic research project. But I've never forgotten what I learned. It motivates me; it has become my vocation."

Today he is actively involved in helping to find a viable treatment for pancreatic cancer and is raising funds for the Dana-Farber Cancer Institute (DFCI) by cycling in the Pan-Massachusetts Challenge. In 2007, he raised $4,000 and every penny went directly to the institute.

It is a fitting way to honor and remember a man who was himself fit and active. Jon Connor was a keen runner and cyclist who particularly liked highly challenging courses.
"For my dad, there was no easy button; 'hills are your friends', he would say, much to the chagrin of his teammates in the Parkway Running Club before setting out on the infamous Dover run,' Mr. Connor says.

When Mr. Connor rode in this year's Pan-Massachusetts Challenge he did so on his father's favorite bike: an old Italian road bike.

Champion: Chris Connor, Director, Product Development, Phoenix Data Systems, which delivers EDC, eClinical and Imaging services.

Cause: The Pan-Massachusetts Challenge draws more than 5,000 cyclists, who hail from 36 states and eight countries. Now in its 30th year, the PMC hopes to increase its gift ($35 million in 2008) from the efforts put forth by PMC cyclists on Aug. 1 and 2, 2009. It is the largest single contributor to the Jimmy Fund, bringing in almost 50% of its annual revenue. The Jimmy Fund supports cancer research and care at the Dana-Farber Cancer Institute. To learn more about the Pan-Massachusetts Challenge, visit pmc.org. To learn more about the Dana-Farber Cancer Institute, visit dand-farber.org.

Contact:
Jim Dorsey, VP – Marketing
BioClinica
Tel: 267-757-3040

Bio-Imaging Technologies to Present at The UBS Global Healthcare Services Conference on February 9, 2009 at the Waldorf Astoria Hotel in New York City.

Sun, 26 Apr 2009 20:37:11 -0400

NEWTOWN, PA, January 29, 2009 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced Mark L. Weinstein, President and Chief Executive Officer will be presenting at the UBS Global Healthcare Services Conference in New York City on Monday, February 9, 2009 at 2 p.m.

Mr. Weinstein will be discussing an overview of Bio-Imaging Technologies, including its focus on providing clinical trial services, including medical image management and eClinical data services to support the product development process for the pharmaceutical, biotechnology and medical device companies.

Bio-Imaging Technologies Sells CapMed Division to Metavante Technologies.

Sun, 26 Apr 2009 20:39:41 -0400

NEWTOWN, PA, January 7, 2009 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced the sale of its CapMed Division (“CapMed”) to Metavante Technologies, Inc. (“Metavante”) (NYSE: MV).

Mark L. Weinstein, President and Chief Executive Officer of Bio-Imaging said, “With the sale of CapMed, we can now focus all of our efforts on Bio-Imaging’s core business of providing clinical trial services, including medical image management and eClinical data services to support the product development process for the pharmaceutical, biotechnology and medical device companies.

Bio-Imaging Technologies Partners with AG Mednet to Offer Complete Imaging Solution for Clinical Trials

Fri, 02 Oct 2009 18:55:34 -0400

NEWTOWN, PA, December 8, 2008 – Bio-Imaging Technologies, Inc. (NASDAQ: BITI), a healthcare contract service organization that supports product development for the pharmaceutical, biotechnology and medical device industries, today announced it has partnered with AG Mednet, a global diagnostic imaging network, to provide a complete imaging service for clinical trials. The new service enables fast delivery of clinical trial images through a web accessible, secure network between clinical sites and Bio-Imaging’s Imaging Core Lab (ICL), increasing efficiency while reducing costs. The service, which is available immediately, has already been deployed for active studies with Bio-Imaging’s major pharmaceutical clients.

Bio-Imaging Technologies Announces Third Quarter 2008 Financial Results

Fri, 02 Oct 2009 18:53:20 -0400

NEWTOWN, PA, November 5, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced its third quarter and nine months ended September 30, 2008 financial results, including the operating results of Phoenix Data Systems, Inc. (“PDS”) as a result of the acquisition of PDS completed March 24, 2008.

Bio-Imaging Technologies to Release Third Quarter 2008 Financial Results and Host Conference Call on November 5, 2008

Fri, 02 Oct 2009 18:57:50 -0400

NEWTOWN, PA, October 27, 2008 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI) will release its financial results for the third quarter ended September 30, 2008 on Wednesday, November 5, 2008.

Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EST to discuss the company’s financial results and achievements. Those who wish to participate in the conference call may telephone (888) 335-6674 from the U.S. or (973) 321-1100 for international callers, conference ID# 70789095 approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioimaging.com. A digital replay will be available by telephone for two weeks and may be accessed by dialing (800) 642-1687, from the U.S., or (706) 645-9291, for international callers, conference ID# 70789095. The replay will also be on the website under “Investor Relations” at www.bioimaging.com for two weeks.

Bio-Imaging Technologies to Present at the SIDOTI & Company's New York Growth Institutional Investor Conference on October 28, 2008 at 8:30 am

Fri, 02 Oct 2009 19:00:22 -0400

NEWTOWN, PA, October 20, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that its President and Chief Executive Officer, Mark L. Weinstein, will be presenting at the Sidoti & Company’s New York Emerging Growth Institutional Investor Conference II on October 28, 2008 at 8:30 am. The one day conference is being held at The Grand Hyatt Hotel in New York City.

Bio-Imaging Technologies Appoints Peter S. Benton President of its Phoenix Data Systems Division

Fri, 02 Oct 2009 19:02:47 -0400

NEWTOWN, PA, September 29, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that it has appointed Peter S. Benton as President of its Phoenix Data Systems (“PDS”) Division. PDS is a leading global clinical data services provider of electronic data capture (“EDC”) services offering a comprehensive array of broadly interoperable eClinical data solutions to its pharmaceutical and biotechnology customers. Mr. Benton will succeed Dr. William Claypool, who is leaving PDS to start a pharmaceutical development consulting company, Pennmark Associates, LLC.

Bio-Imaging Technologies Announces Election of Adeoye Olukotun to Board

Fri, 02 Oct 2009 17:37:11 -0400

NEWTOWN, PA, August 25, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that Adeoye Olukotun, MD has been chosen by the company's Board of Directors to serve as a director on Bio-Imaging’s Board, effective August 25, 2008.

PDS Acquisition Boosts Bio-Imaging Earnings

Sun, 26 Apr 2009 20:57:51 -0400

As posted on CenterWatch.com:

Thursday, August 21, 2008 02:47 PM

Newtown, Pa.-based contract research organization (CRO) Bio-Imaging Technologies released second quarter financial results that show a 61% increase in service revenues compared with the same period a year ago. Revenues hit $15.2 million for its second quarter compared with $9.5 million for the same period last year. This most recent earnings report reflects the operating results of Bio-Imaging's March 2008 acquisition of Phoenix Data Systems (PDS). Bio-Imaging's backlog increased 44.6% to $115.8 million, of which $17.2 million is attributable to PDS. Based on Bio-Imaging Technologies success during the first half of the year, president and chief executive officer Mark Weinstein said the company is increasing its 2008 service revenue guidance to $53 million to $56 million, up from $53 million to $55 million.

Read the full article

Bio-Imaging Technologies to Release Second Quarter 2008 Financial Results and Host Conference Call on July 30, 2008

Fri, 02 Oct 2009 18:40:06 -0400

NEWTOWN, PA, July 22, 2008 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI) will release its financial results for the second quarter ended June 30, 2008 on Wednesday, July 30,2008.

Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EDT to discuss the company’s financial results and achievements. Those who wish to participate in the conference call may telephone (888) 335-6674 from the U.S. or (973) 321-1100 for international callers, conference ID# 56203548 approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioimaging.com. A digital replay will be available by telephone for two weeks and may be accessed by dialing (800) 642-1687, from the U.S., or (706) 645-9291, for international callers, conference ID# 56203548. The replay will also be on the website under “Investor Relations” at www.bioimaging.com for two weeks.

Bio-Imaging Technologies Announces Second Quarter 2008 Financial Results

Fri, 02 Oct 2009 18:44:10 -0400

NEWTOWN, PA, July 30, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced its financial results for the second quarter and six months ended June 30, 2008.

Financial results for the second quarter and first half of fiscal 2008 include the operating results of Phoenix Data Systems (“PDS”) as a result of the acquisition of PDS, which was completed March 24, 2008.

Bio-Imaging Technologies to Present at the Roth 20th Annual OC Growth Stock Conference on February 20, 2008 at 9:30 am PST

Fri, 02 Oct 2009 17:56:19 -0400

NEWTOWN, PA, February 4, 2008 Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that its President and Chief Executive Officer, Mark L. Weinstein, will be presenting at the ROTH 20th Annual OC Growth Stock Conference at 9:30 am PST on February 20, 2008. The presentation will be webcast and listeners may access it via http://www.wsw.com/webcast/roth13/biti.

The ROTH 20th Annual OC Growth Stock Conference, sponsored by Roth Capital Partners, runs February 18-21, 2008, and will be held at the Ritz Carlton Laguna Niguel in Dana Point, CA.

Bio-Imaging Technologies and Phoenix Data Systems to Exhibit at Drug Information Association's [DIA] 44th Annual Meeting

Fri, 02 Oct 2009 17:40:42 -0400

NEWTOWN, PA, June 17, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that it will co-exhibit with recently acquired Phoenix Data Systems at the Drug Information Association’s [DIA] 44th Annual Meeting to be held June 22-25, 2008 in Boston, Massachusetts.

Bio-Imaging Technologies and Phoenix Data Systems will occupy booth #1444 at the Boston Convention and Exhibition Center. Phoenix Data Systems will showcase its electronic data capture (EDC), interactive voice response (IVR), and data management solutions for improved clinical trials. Bio-Imaging will feature the industry’s foremost solutions for medical image management in clinical trials. This unique combination offers an unmatched array of resources, capabilities, and experienced professionals to help maximize the statistical power of clinical data, to better meet timelines and budget, and to obtain regulatory approval.

Connecting IVR & Drug Supply - Trident: New Web Rand System

Tue, 06 Oct 2009 19:18:16 -0400

As posted on Clinpage.com:

Is the $300 million interactive voice response system (IVRS) industry ripe for change? Is it failing to keep pace with the timelines of industry? Is it possible to transfer randomization to the web and have the customized nuances embedded in the system?

Yes on all counts, says Ed Tourtellotte, proprietor of the 35-person Tourtellotte Solutions. We last profiled the company about a year ago. His new randomization software is called Trident IWR; you can read more about it here online and in this press release.

As befits someone who drives a Maserati, Tourtellotte prefers speed to torpor. Ease over delay. And he says flatly that existing companies in the IVR space are not able to handle all the work being directed their way. He prefers the "IWR" designation because of the inevitability of the web being used to randomize patients.

Quick Start

“We’ve taken the 12 week study setup time and turned it into 12 minutes,” says Tourtellotte. “This is how you should doIVR or IWR. The web is way better than the phone. We are blowing people’s hair back,” he adds, in a reference to the loudspeaker ads of another generation.

The combination of IVR and electronic data capture (EDC) has been explored by a handful of technology providers, but most sponsors seem to prefer a separate, standalone randomization system. Tourtellotte’s Wayland, Massachusetts company offers a new twist: randomization that can be driven by (and affect) drug supply tools from the same firm.

Drug Supply Simulation

There is no question that Tourtellotte is handling IVR and drug-supply consulting projects for prominent sponsors that don’t allow their names to be used. And there is also no question that the dependability of randomization is sufficiently important that the firm will have to prove itself to overtake the current established names in the IVR space, whether that's ClinPhone, Almac or Icon.

Tourtellotte says the whole present approach to IVRS is antiquated. “It’s error prone. It’s clunky,” he says. “The power of the business experts who interpret the protocol ends at the limits of the specifications they write.”

The history is interesting. Along the way to refining tcVisualize, his supply simulation software, Tourtellotte recognized he already had most of the pieces of an IVR. So, as a typical tinkerer, he set about to build the rest. And to figure out a way to get the randomization and simulation systems to talk to each other, using an XML data export. So now both Trident and tcVisualize can use the same XML file format.

That will let sponsors use their supply simulations to configure their randomization. Similarly, actual data from the randomization engine can be used to further refine their simulations of supply. The hope is to avoid any drug supply overage that may not be completely necessary, and to anticipate out-of-stock situations long before they arise.

Can IVR Scale?

Tourtellotte opines that the leading vendors of IVR solutions, while doing their best, find themselves in a tough spot. Doubly so. The current IVR systems are cumbersome for vendors to build, with programmers disappearing for weeks or months after the business requirements have been spec'd out. “All the legacy IVR vendors are trapped,” Tourtellotte says. “The IVRS industry is under phenomenal pressure. You can see major outages. They can’t scale. They’re going crazy. The scaling is the key.”

Traditional IVR systems are also unpleasant for users at clinical sites, Tourtellotte says; clinical research associates don't like punching in letters and numbers in a telephone keypad.

Under the hood of many IVR systems, he insists, there is at least one more vulnerability. A different database schema is often used for every trial, meaning that it’s hard to leverage work from one trial to another. Tourtellotte started with a blank sheet of paper and figured out that perhaps 80 percent of the IVR setup process could be managed with pick-lists, drop-down menus and other conveniences that (he stresses) do not require any professional software experience. Much of his code can be reused.

Bypassing Programmers

And his IVR system can be set up by ordinary clinical operations people, folks who could not write a line of code to save their lives. Says Tourtellotte: ”Business users set up the data and administer it using switches and knobs—and not programming.” The elements that can be configured with such parameters include the basic study design, drug kits, visit schedules, dosage rules, formulations and dispensing schedules.

What about the rest of the 20 percent of the requirements? Such stuff may be coded by the customer, or by Tourtellotte’s programmers. It’s here that he feels the Trident software shines. “No one else has figured out how to architect custom-pluggable code,” says Tourtellotte. He says even with custom coding for the last 20 percent of the process, it will still be far faster than existing techniques from other suppliers. Indeed, he goes so far as to say the present IVR approach is past its prime. “It’s a dinosaur,” says Tourtellotte. “It needs to be extinct.”

He’s often asked if the system supports voice, i.e., whether a phone keypad could be used to randomize patients at sites that have bad internet access. The answer is: yes. But he sees an eventual transition away from the phone, thanks to user preferences and the rise of electronic data capture.

Web Bias

“People hate the phone,” says Tourtellotte. “I spend a lot of time railing against voice, and then I say, ‘we’re going to do it anyway.’” He says few protocols in the age of electronic data capture really require voice; most sites are online and prefer to randomize patients using the web.

But Tourtellotte does appreciate that a few sites in the Borneo jungle or the Siberian steppes may not have broadband internet access, or have ever seen a computer. On such occasions, Tourtellotte believes, there may be alternate methods to bring in the data: perhaps just dedicating a person or help desk. But he’s as resigned to voice as suppliers of electronic data capture are to paper.

Adaptive, Minus Hype

It’s not necessary or obligatory to combine tcVisualize, his drug-supply simulation system, and Trident, the new randomization tool. But Tourtellotte is convinced there are significant opportunities for efficiency for companies taking that approach.

The idea is that systems for drug supply and randomization should be in sync given that that is the case as a trial unfolds. When Tourtellotte hit Trident’s “play” button, the spectacle was as far from Microsoft Excel as Microsoft Excel is from an abacus. It’s very clear what supplies are where. “I’ve got an instant global picture of my trial. I can simulate forward given my actual state,” says Tourtellotte. “The more data you have, the better your forecast is. If you’re going to change something, you can add that to your forecast.”

The technology could facilitate adaptive designs, Tourtellotte says, though he quickly concedes there are not many such protocols under way. Says Tourtellotte: “There is all this hype around it. I don’t want to slam adaptive trials. Bad designs are flooding the FDA. There is some risk that the adaptive paradigm could fail. There are some adaptive designs that are phenomenally great. I want to help it get there.” His firm is working with Cytel, as we wrote here a while back.

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Bio-Imaging Technologies Announces First Quarter 2008 Financial Results

Fri, 02 Oct 2009 18:51:20 -0400

NEWTOWN, PA, May 7, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced its financial results for the quarter ended March 31, 2008.

First quarter financial results exclude the operating results of Phoenix Data Systems (“PDS”) but include the combined balance sheet of PDS and Bio-Imaging as a result of the acquisition of PDS, which was completed March 24, 2008. The operating results of PDS will be included in our second quarter financial results.

Bio-Imaging Technologies to Release First Quarter 2008 Financial Results and Host Conference Call on May 7, 2008

Fri, 02 Oct 2009 18:42:16 -0400

NEWTOWN, PA, April 30, 2008 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI) will release its financial
results for the first quarter ended March 31, 2008 on Wednesday, May 7, 2008.

Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EDT to discuss the company’s financial results and achievements. Those who wish to participate in the conference call may telephone (888) 335-6674 from the U.S. or (973) 321-1100 for international callers, conference ID# 56203548 approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioimaging.com. A digital replay will be available by telephone for two weeks and may be accessed by dialing (800) 642-1687, from the U.S., or (706) 645-9291, for international callers, conference ID# 56203548. The replay will also be on the website under “Investor Relations” at www.bioimaging.com for two weeks.

Bio-Imaging Expects Synergies with Phoenix Data Systems Acquisition

Sun, 26 Apr 2009 20:59:56 -0400

As posted on BioITWorld.com - By Ann Neuer

April 28, 2008 | Bio-Imaging Technologies Inc., a provider of medical image management for clinical trials, has acquired Phoenix Data Systems Inc., a privately held electronic data capture (EDC) company. Phoenix is now a division of Bio-Imaging.

At first glance, this looks to be an unusual pairing as the two outfits occupy different niches in the clinical trials sector. But each company had been looking to move to the next level within the industry by expanding their service offerings.

Mark Weinstein, president and CEO of Bio-Imaging, says that his company has had a tremendous interest in the EDC market, which it estimates as a $1 billion opportunity within five years. "We've been wanting to be a player in the EDC space, which we see as closer to the center of the clinical data universe," says Weinstein. To reach this goal, Bio-Imaging talked to numerous players in the EDC sector and discovered that more than a few were in precarious financial situations or lacked dedication to excellence in customer service.

In Phoenix, Bio-Imaging found a rapidly growing company with a very hands-on management committed to top-notch customer service. "Phoenix has a good, solid EDC system that has been used in over 500 clinical trials. Once we understood what Phoenix was trying to do, we realized we could leverage our core competencies to make more together than we could individually," Weinstein explained.

Bio-Imaging brings critical mass, financial stability, an international presence in the medical imaging market, and good business know-how to the table. Phoenix brings a strong client base of small to mid-size biopharmaceutical companies; nearly 200 new starts using the company's EDC solution, PDS Express, scheduled for 2008; and financial strength as the company has been built without taking in venture capital.

William Claypool, M.D., president of Phoenix Data Systems, was interested in the acquisition opportunity because he points out that more studies are using imaging data in the clinical trial process. "About one-third of all development projects are in oncology today and many are using imaging data as regulatory endpoints. For example, being free of cancer is demonstrated by imaging. In other areas such as neurosciences, cardiovascular, and musculoskeletal diseases, proof of concept is occurring in imaging," Claypool comments.

With expanded use of imaging in clinical trials and adoption rate of EDC growing rapidly, both companies see clear opportunities for entry into each other's markets. At this time, sales forces will remain separate but will look for synergies. Claypool says, "Because many of our clients are smaller companies, decisions about EDC and imaging may be made by the same people. Our relationships with those clients will help us introduce them to imaging."

In the short term, data sets generated by Bio-Imaging and Phoenix Data Systems will not be integrated, although in the long term that may change if data from medical images come together earlier in the process, particularly with the advent of adaptive clinical trials. To get started, Bio-Imaging and Phoenix Data will continue to function separately although Bio-Imaging will be handling many back-office management functions.

"We see Phoenix Data as creating our next foundation for growth," says Weinstein.

Read the complete article

EDC & Imaging Combination Bio-Imaging, PDS Seek More Size

Sun, 26 Apr 2009 21:02:55 -0400

As posted on ClinPage's website:

April 1, 2008 | How big do clinical trial technology firms need to be? Is there a magic size large enough to be financially strong but small enough to provide impeccable service?

Last week's $24 million purchase of electronic data capture firm Phoenix Data Systems by Bio-Imaging is an indication of companies searching for the right size. The two firms decided they would fare better if they were joined. By their own account, the two firms a good cultural fit, both more than 10 years old, both based in the Philadelphia area, both hype-averse.

Imaging + EDC

With 440 employees between them, 80 outside the U.S., Bio-Imaging and Phoenix Data Systems are eyeballing a putative $1 billion market for EDC, and a $400 million market for clinical trial-specific imaging. The combined company has roughly half the head count of ClinPhone, but approximately the same human heft as industry leaders Phase Forward and Medidata Solutions.

Bio-Imaging is hoping that customers will want a more unified platform or suite in which to collect and manage clinical data. Bio-Imaging president and CEO Mark Weinstein says imaging and EDC are destined to be more unified, more integrated. "Ultimately, you're going to see the coming together of the two pieces," he says. Even imaging customers increasingly need their X-rays and CT scans managed as submission-ready clinical data, he reports. Clinical trial imaging has been in the news of late, with the timeliness of review of images a festering issue among critics of the industry.

Getting Big

The logic behind the acquisition? Access to the booming EDC market. Rather than buy a weak, struggling firm, Bio-Imaging chose a strong middle-tier EDC supplier. "We don't feel like spending three years rebuilding something that is having problems," Weinstein says. "The excitement is generated by two companies that are hitting on all cylinders."

One consideration in the merger was the absence of any potentially conflicting standard operating procedures for ongoing projects, Weinstein says. It's an issue that might affect other deals in the space. But Bio-Imaging and Phoenix Data Systems will be able to help out each others' clients immediately, rather than waiting for ongoing trials to finish, and then phasing in a new batch of SOPs for the post-merger entity.

The way Weinstein tells it, no imaging-oriented rivals can serve customers across all of the therapeutic areas in which images must be centrally managed in the assessment of an important scientific end point. Bio-Imaging is managing 220 projects in those four areas: oncology, central nervous system, musculoskeletal and cardiovascular disease. "We are the only player that covers the four major areas," Weinstein says.

Bio-Imaging's appetite for additional acquisitions, Weinstein says, is strong, given $10 million in the bank even after the PDS purchase. Venture-funded rivals (RadPharm, Synarc) are present in the imaging space, and prosperous but small-or huge, like Perceptive Informatics, a division of contract research giant Parexel. But none of those imaging firms currently has an in-house EDC solution.

Tipping Point

Weinstein notes that when he first came to Bio-Imaging, he dedicated himself to quietly building a profitable business, prior to visiting Wall Street and promoting the company to the financial community. "We put our head down," he says. "We built our backlog. We stayed very quiet." Some EDC vendors, he suggested, went public first and worried about profitability or a consistent revenue stream later.

With any luck, some of Bio-Imaging's customers (which range across all sizes of sponsors) will be thinking about EDC, and some PDS customers will need imaging. The goal is to help customers early in the research process with both imaging and EDC, and carry through as many phases of projects as they need. Weinstein says: "We will be able to create some efficiency drivers in terms of the convergence of data early in the process. I am not sure which of our competitors can match that."

On a call with Wall Street analysts, he said: "The EDC market is therefore at a tipping point."

Adaptive Agility

Weinstein says the number of live adaptive projects is small, but believes the pressure to find patients is so great that adaptive trial designs will be a factor in the years ahead. "If adaptive trials can get you to the same end point with two-thirds as many patients, that's got to be a huge winner," says Weinstein. "Very few people have enough data available to them to make decisions on a real-time basis. You cannot get there unless you have access to the data quickly."

Part of the way you do it, of course, is with an interactive voice response system, or an EDC system-the industry has not yet decided which type of system should power adaptive projects. PDS has an integrated IVR/EDC system, not to mention an embedded clinical trial management system (CTMS).

In that space of integrated clinical trial solutions, there is a growing number of firms that includes Almac, Clarix, DataTrak, etrials and ClinPhone. Bio-Imaging will have to wrestle with one of Phoenix Data Systems's core areas of expertise-intricate but profitable data management services that most large contract research organizations (CRO) would prefer to keep to themselves.

Growth Strategy

Fully a third of the current PDS projects are in Phase I, which is probably the most intriguing factoid about the company. Some EDC providers have begun tip-toeing into Phase I projects, but the small size of such studies means that using paper may be faster and cheaper.

Making a business out of EDC in Phase I is a rare accomplishment, but PDS's chief William Claypool is (refreshingly) missing the carnival barker gene to shout that to the rooftops. It's clear he thinks that selling his firm will help it win business from larger sponsors. "We're going to be better positioned with big pharma," Claypool says. "Growth eats cash. We feel we can grow faster and take care of employees, and do better for ourselves by being acquired."

'Microcap Hell'

Claypool muses that some publicly traded clinical technology firms may have wished they had remained private. "It's pretty clear you need a certain mass to make going public have any sense in the post-Sarbanes Oxley environment," says Claypool. "If you do not have a certain revenue level, it is very difficult to justify the ongoing public filing. Those companies are in a microcap hell. It is very difficult to raise more money. It is very difficult to raise their share price. It is better to stay private." He'll be staying on at Bio-Imaging to lead the PDS group inside Bio-Imaging.

Claypool says there will be fewer firms in the clinical trial landscape. "It doesn't take a very astute observer to see there is a trend toward consolidation." It happens in every sector of the technology industry. "This happens over and over again," he says

Click here to read the full article>>

Drug Pooling: Power and Pitfalls

Tue, 06 Oct 2009 18:52:17 -0400

As posted on Applied Clinical Trials Online:

Apr 1, 2008
By: Dave Riege, Ed Tourtellotte
Applied Clinical Trials

Drug pooling's potential to reduce waste and minimize supply outage is of keen interest to biopharmaceutical companies. Yet confusion persists about what pooling can and cannot do—and about how pooling can and cannot be done.1

Pooling, which is employed in conjunction with IVRS/IWRS, is possible when more than one protocol operating at the same depot and/or clinical site uses the same drug. By treating identical supplies as commutable among pooled protocols, pooling allows supply and safety stock to be shared. With pooling, dispensing units are interchangeable (indistinguishable in content, count, and container/closure system) and while in their pooled state, they are protocol independent, with a single, shared IVRS definition.

There are three basic levels of pooling that might be of interest to clinical trial designers and managers. First, a fairly obvious one: pooling a set of packaged kits or kit components that are not yet labeled. We might call this "Pooling Prior to Labeling." This method is uncontroversial and is out of the scope of this article.

A second method is to deliver packaged and labeled goods to depots without a protocol number on the label. This is useful for a variety of different simultaneous clinical trials in the same program (or at least using the same kit types). We might call this method "Pooling at Depots."

Pooling at Depots is somewhat more controversial because it requires that the protocol number be written or affixed to the label of all kits prior to shipping, but after being requested by clinical sites (usually via IVRS) for particular trials. Both the process around this activity and the regulations in various countries—especially in Europe—are rather unclear. However, Pooling at Depots represents a significant clinical supply advantage over Pooling Prior to Labeling, and is thus worth consideration.

The third method of pooling encompasses Pooling at Depots but also makes the assumption that some clinical sites may be running multiple "pooled" protocols at more or less the same time. In this type of pooling, kits may actually be shipped from the depot without a single protocol number, although sometimes they do show a set of protocols, or a program code. In any case, the kits remain protocol independent, even at the clinical site, until they are dispensed. At dispensing time, the IVRS marries the protocol to the kit number and any required label modifications may be made at the site. We might call this method "Pooling at Sites."

Pooling at Sites, done when there is more than one protocol operating at the same investigative site, is actually far more commonly applicable than may be apparent at first blush. Although in earlier phase studies it is uncommon to have multiple studies sharing the same formulation, in later Phase III and IV studies it is not uncommon at all. However, many clinical supply managers interpret various European or other regulations as prohibiting the shipment of drug to sites without a protocol number on the label. Others note that exceptions are made in cases where centralized randomization systems are used. Others still note that regardless of the letter of the law, certain regulatory agencies will never allow pooling at sites. A common reaction to the notion of pooling at sites is "good luck."

Pooling for Europe

Nevertheless, Pooling at Sites does indeed occur in the biopharmaceutical world, and has indeed been shown to save significant supply when used. We will assume that the reader accepts on some level the regulatory viability of Pooling at Sites, even if the concept is neither universally endorsed nor applicable to all geographies. The remainder of this article will address specific pitfalls and requirements of Pooling at Sites both in terms of electronic records and of actual labeling.

As noted above, in Pooling at Sites, the IVRS does not marry any particular kit to a protocol or subject ID until the kit is disbursed. This allows the IVRS/IWRS to tally stock against the future needs of all the protocols at a particular location: All projected shortfalls can be covered with a single, nonprotocol-specific shipment. That shipment will equal the location's projected need for a specified period (minus at location and en route unexpired/ing stock). Each patient in a pooled protocol may be dispensed the appropriate kit type from the common supply.

Traditionally, clinical supply managers package lot for a particular protocol. In a pooling scenario, they may naturally assume that they can and should package or electronically earmark the drug for the set of protocols for which it is to be used. However, marking drug for use electronically or on the label for a specific protocol—or even for a subset or specific group of protocols—can compromise pooling. Only if kits are protocol independent until dispensed can an IVRS resupply algorithm consider the needs of all protocols using a particular kit at a single location as a whole.

Murphy's ABC protocols

Consider, as an illustration, the predicament of Murphy, a clinical supply specialist. His protocols, A, B, and C all use a dispensing unit type called "10mg Samplovir." In this example, we will focus on only one physical location, "Fenway," where all three protocols are being conducted.

Doing what he's always done, Murphy packages "Lot 1" of 10mg Samplovir, labels, electronically marks it in the database for protocols A, B, and C, and distributes it to his supply chain.

In marking for specific protocols, Murphy has broken pooling's fundamental principle that dispensing units must be protocol independent. But the protocols for which he has labeled happen to be the only protocols that use 10mg Samplovir, so all drug need calculations—for plotted subject consumption, safety stock, floor/ceiling—are successfully totaled.

Now, however, Murphy packages a "Lot 2" of 10mg Samplovir. He feels that protocol C is just about wrapped up and does not want to dedicate any new supply to it. So this time he only marks it for protocols A and B. Murphy distributes Lot 2, and some ends up at Fenway alongside Lot 1.

Murphy's supply at Fenway is now comprised of 17 total dispensing units of 10mg Samplovir: two units of 10mg Samplovir from Lot 1 and 15 units of 10mg Samplovir from Lot 2. Lot 1 is usable for protocols A, B, and C, but Lot 2 is only usable for protocols A and B. In this example, he still has subjects enrolled and active at this location for all three protocols.

That night, Murphy's resupply algorithm now begins counting his supply at Fenway. When it counts drugs at location, it can no longer count all 17 units of 10mg Samplovir together in a single bucket. At a minimum, it needs to count once for protocols A, B, and C (two units) and again for protocols A and B together (15 units). There is no way for the algorithm to represent the stock with a single number for the location. At the moment, however, this is little more than an inconvenience.

The following week, Murphy needs to supply drugs for projected subject need. Protocols A, B, and C have two subjects each scheduled to arrive in the next week; each subject is scheduled to receive one 10mg Samplovir. Ordinarily, a pooled supply algorithm would compare this summed need (six units) against stock at the site (17 units), but since Murphy broke the absolute nature of the pool, the algorithm must count the needs against the stock at site separately.

If the algorithm does this for each protocol separately, it may predict that the needs of protocols A and B for two each will be easily supplied by their total available stock of 17 and 17, respectively, and that protocol C's need for two will also be covered by the remaining Lot 1 supply of two. But the algorithm's prediction may not necessarily be correct.

Scheduled Dispensing Visits at Fenway

Consider the drug consumption for randomized subjects scheduled to have dispensing visits at Fenway during the following week. If both subjects from protocol C arrive earlier than subjects from protocols A and B, one should see something like what appears in Table 1.

Fenway Encounters Dispensing Problems

The order of the last four subjects, in this case, does not really matter; it matters only that the subjects from protocols A and B all arrive after the subjects from protocol C. But what happens if a subject from protocols A or B arrives prior to a subject from protocol C? The dispensing algorithm should be dispensing the oldest usable medication first so Lot 1 will be consumed by subjects in protocols A and/or B (see Table 2).

Algorithm vs. IVRS

The more subjects are intermingled at a location and the more stock is labeled for different subsets of protocols, the worse the problem gets. Even in this example, if subjects from A or B arrive in the first two dispensing positions, both subjects from protocol C will encounter stock-outs and be lost. Losing subjects in this manner is clearly unacceptable. Why can't an algorithm figure out on the fly which lots are for which sets of protocols and do the math accordingly?

While it may seem intuitive that the algorithm should be able to do modified calculations to rescue Murphy, or at least to set aside the Lot 1 stock for the protocol C subjects, in fact the algorithm is ill suited to the task. To preserve certain drugs for the projected need of specific incoming subjects, the dispensing algorithm would need to be linked to the predictive resupply algorithm, and the two functions are mismatched.

Dispensing in IVRS studies is an uncomplicated operation: The algorithm looks at the dispensing unit type(s) required by the subject, chooses the earliest expiring usable unit(s) from stock at the site, and dispenses. This simple process is carried out in real time many times a day to provide drugs to subjects. A resupply algorithm, by contrast, is a very complex process that usually runs once a day and considers numerous factors and projections in its decision making.

Conclusion

All in all, drug pooling has the potential to increase supply efficiency in an unexpectedly wide range of scenarios, although its limits may be unexpected. As the inherent flexibilities and inflexibilities of the technique—and the breadth of situations in which it can help contain costs—become more commonly understood, the use of drug pooling will undoubtedly continue to expand.

Dave Riege is associate research fellow in supply chain management at Pfizer. Ed Tourtellotte* is the founder and chief executive officer of Tourtellotte Solutions, 321 Commonwealth Road, Suite 303, Wayland, MA 01778, email: etourtel@tci9.com

*To whom all correspondence should be addressed.

References

1. L. George, "Investigational Medicinal Products—Optimizing the Supply Chain," Applied Clinical Trials, April 2005, 42–48.

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Bio-Imaging Acquires Phoenix Data Systems, a Leading Provider of Clinical Data Services

Fri, 02 Oct 2009 17:31:50 -0400

NEWTOWN, PA, March 25, 2008 -- Bio-Imaging Technologies, Inc. ("Bio-Imaging") (NASDAQ: BITI) today announced that it has acquired privately held Phoenix Data Systems, Inc., a leading global clinical dataservices provider of electronic data capture (EDC) services and a comprehensive array of broadly interoperable eClinical data solutions to the pharmaceutical and biotechnology industries. The acquisition is a cash and stock transaction valued at $24 million, payable at closing, consisting of $7.0 million of cash and2,287,582 shares of Bio-Imaging stock valued at $17.0 million. Together Bio-Imaging and Phoenix Data Systems will offer a broader set of clinical trial services to its pharmaceutical and biotechnology customers. The global EDC services market is increasing rapidly and within five years is expected to increase Bio-Imaging's addressable market in the clinical trials space to over $1 billion.

Bio-Imaging Technologies to Present at the SIDOTI & Co. 12th Annual New York Emerging Growth Institutional Investor Forum on March 25, 2008 at 1:30 pm

Fri, 02 Oct 2009 18:03:30 -0400

NEWTON, PA, March 18, 2008 -- Bio-Imaging Technologies, Inc. (“Bio-Imaging”) (NASDAQ: BITI) today announced that its President and Chief Executive Officer, Mark L. Weinstein, will be presenting at the Sidoti & Co. 12th Annual New York Emerging Growth Institutional Investor Forum on March 25, 2008 at 1:30 pm.

The conference is being held at The Grand Hyatt Hotel in New York City March 25 and 26, 2008.

Bio-Imaging Technologies to Release Fourth Quarter and 2007 Year End Financial Results and Host Conference Call on February 13, 2008

Fri, 02 Oct 2009 18:37:03 -0400

NEWTOWN, PA, February 6, 2008 -- Bio-Imaging Technologies, Inc. (NASDAQ: BITI) will release its financial results for the fourth quarter and fiscal year ended December 31, 2007 on Wednesday, February 13, 2008.

Management of Bio-Imaging Technologies, Inc. will host a conference call on the same day at 11 a.m. EST to discuss the company’s financial results and achievements. Those who wish to participate in the conference call may telephone (888) 335-6674 from the U.S. or (973) 321-1100 for international callers, conference ID# 32770012 approximately 15 minutes before the call. There will be a simultaneous webcast on www.bioimaging.com. A digital replay will be available by telephone for two weeks and may be accessed by dialing (800) 642-1687, from the U.S., or (706) 645-9291, for international callers, conference ID# 32770012. The replay will also be on the website under “Investor Relations” at www.bioimaging.com for two weeks.

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BioClinica Adds Image Transport to its Integrated Product Suite

As posted on eCliniqua's website:

BioClinica to Host Medical Imaging Symposium for Rheumatoid Arthritis Clinical Trials on November 18 2009

BioClinica Announces Third Quarter 2009 Financial Results

Company Interview Excerpt BioClinica, Inc. - Mark L. Weinstein

As posted in The Wall Street Transcript:

eClinical for Today and Tomorrow

As posted in DIA's Global Forum:

BioClinica, Inc. to Release Third Quarter 2009 Financial Results and Host Conference Call on November 4, 2009

Bioclinica Showcases Clinical Data Management at SCDM Annual Conference

BioClinica Acquires Tourtellotte Solutions

As posted on eCliniqua's website:

BioClinica: Why Supplies Matter

As posted on ClinPage's website:

Supplies = Sexy?

Adaptive Angle

Attaining Scale

Real ROI

Avoiding Outages

Integrated Offering

BioClinica Buys Tourtellotte in Busy Acquisition Month

BioClinica Acquires Tourtellotte Solutions

BioClinica Acquires CardioNow from AGFA Healthcare

In Search of Paperless Clinical Trials

BioClinica™ Announces Second Quarter 2009 Financial Results

BioClinica, Inc. to Present at BMO Capital Markets Focus on Healthcare Conference on August 5, 2009

BioClinica, Inc. to Release Second Quarter 2009 Financial Results on August 4, 2009

Bio-Imaging Technologies, Inc. Shareholders Approve Company's Name Change to BioClinica, Inc.

-Stock Symbol to Change to "BIOC" Effective July 13, 2009-

Best DIA Exhibitors

As posted on ClinPage's website:

Brangelina Buzz

BioClinica’S Jonathan Andrus Named Chair of DIA’S eClinical SIAC

BioClinica’s Express Platform Receives CDISC Certification

Microsoft Announces Winners of the 2009 Pharmaceutical and Life Sciences Innovation Awards

BioClinica Advances Standards Support at DIA 2009

New Software to Improve Clinical Trial Performance

TranSenda & Harvard Clinical Research Institute Announce Office-Smart Deployment

About TranSenda

About Harvard Clinical Research Institute

HITSP Begins Harmonization Process for Use of Electronic Health Records in Clinical Research

TranSenda Releases Office-Smart Clinical Trial Manager Version 2.0

Bio-Imaging Technologies and Etrials Worldwide Merger Agreement Terminated

Bio-Imaging Technologies D/B/A BioClinica To Participate in Leading Industry Conferences.

Bio-Imaging Technologies Increases Its Offer to Acquire ETrials Worldwide

Bio-Imaging Technologies, Inc. d/b/a BioClinica™ Announces First Quarter 2009 Financial Results

Bio-Imaging Technologies to Acquire Etrials Worldwide

Bio-Imaging Technologies, INC. D/B/A BioClinica to Release First Quarter 2009 Financial Results and Host Conference Call on May 6. 2009

Bio-Imaging Technologies and Phoenix Data Systems Unify Service Offerings as BioClinica™

Development Automatic Classification of Vertebral Shape Based on Statistical Shape Modeling

TranSenda On Panel at BAYBIO Conference

Medical Imaging and Electronic Data Capture in Clinical Trials: the Future Paradigm

As Featured in the Spring 2009 issues of IPI (International Pharmaceutical Industry) magazine:

Medical Imaging and Electronic Data Capture in Clinical Trials: the Future Paradigm.

Introduction

Medical Imaging and Electronic Data Capture

As Featured in the Spring 2009 issues of IPI
(International Pharmaceutical Industry) magazine: