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Finding the Right End-to-End Safety Solution for Your Needs

Finding the Right End-to-End Safety Solution for Your Needs

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  • 25 Jul

Last week, I hosted a webinar titled, "Finding the Right End-to-End Safety Solution for Your Needs." During the webinar, we took an in-depth look at:

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The Art of the Rescue - Navigating Potential Pitfalls during Imaging Vendor Transition

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  • 21 Jul

Once considered a rarity within the medical imaging vendor space, the decision by sponsors to transition imaging core lab after startup has become increasingly more common. Due to the complexity of clinical trials, there may come a time where as a Sponsor you will need to transition vendors after study startup. Reasons for this change of service provider can typically involve challenges with the current provider's timelines, quality, resources, or expertise.

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Introducing OnPoint Direct, Bioclinica's Powerful Rapid Startup CTMS

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  • 19 Jul

With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking. While leading organizations use Clinical Trial Management Systems (CTMS) to centralize operational data and automate processes so they can make better decisions, a CTMS can be out of reach for many small to mid-size companies, leaving them with isolated spreadsheets and/or inefficient, manual practices.

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Meet the Bioclinica Financial Lifecycle Solutions Team: Meghan Harrington, Director of Client Delivery

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  • 14 Jul

At Bioclinica, we are proud to provide our clients with scalable financial lifecycle solutions that can handle global payments as well as integrate with any EDC, CTMS and RTSM. As of April 4, 2016, we've helped Sponsors and CROs make $285 million in payments to 9,012 sites with 70,972 subjects in 63 counties. However, although our technology is a huge factor in our clients' successes, we wouldn't be nearly as successful without the extensive clinical trial expertise that our team members bring to the table.

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What’s Next for the European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) Working in the UK?

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  • 12 Jul

Last week, on June 23, 2016, the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) acknowledged the outcome of the referendum on the United Kingdom's (UK) membership of the European Union (EU).

EMA stated that its implications for the Agency's location and operations depend on the future relationship between the UK and the EU, which is unknown at present.

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CDISC eSource Stakeholders Plan to Supply Pharma with Path Forward for Collection of EHR and Other eSource Data

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  • 11 Jul

CDISC held an eSource stakeholders meeting on March 18, 2016 during the CDISC interchange in Silver Spring, MD. The initial invitation said "During this initial meeting, we plan to discuss the charter and plans for this group as well as introduce members to each other and update the group on recent work."

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TransCelerate Companies Lead the Way in Adopting Risk-Based Monitoring

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  • 06 Jul

I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them.

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Be Fully in Control of Your Clinical Trial Payments Process

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  • 27 Jun

During my years in the clinical research industry working closely with CROs and Sponsors, I've seen many organizations realize the benefits of switching from manual payment processes like Excel spreadsheets, which are time- and resource-intensive as well as error-prone, to automated payment solutions.

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New Apps Emerge for RBM!

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  • 09 May

App xChange adds Virtual Onsite Monitoring (VOS)

In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption.  Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!

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Bioclinica on Worldwide Business with Kathy Ireland

Worldwide Business with Kathy Ireland features Bioclinica!

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  • 06 May

Catch a candid discussion with Bioclinica experts as they discuss clinical trials and ways to simplify the clinical development process in a recent episode of Worldwide Business with Kathy Ireland®!

Each week the Fox Business Network sponsored program explores the real-world insights of corporate executives from around the globe.

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Seamless integration: Getting more from financial management technology

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  • 26 Apr

Sitting in the CFO seat for several years opened my eyes to the significant role spreadsheets have played in financial management in industries such as clinical trials – and their many shortcomings in managing finances. Once the go-to method, spreadsheets are rapidly falling by the wayside as organizations recognize that automated solutions are not time-consuming, cumbersome and error-prone like spreadsheets are.

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Seeking Clarity in the Audit Approach

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  • 18 Apr

Many questions still remain several years after the July 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on the "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies." Further investigation was recommended into the utility of taking an audit approach (central reads of a test sample) to identify potential bias in the local evaluation (LE) of patient data.

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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

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  • 03 Mar

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below.

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7 Advantages of a Site Network vs. Individual Sites for Clinical Trials

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  • 24 Feb
How many investigative sites will you need for your next clinical trial? Will you choose independently-operated sites or a network of sites? Do you know their differences and advantages? We polled our Research Network customers and staff, and share what they said in this blog.
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Reflections on My Experience at the 2017 DIA Pharmacovigilance and Risk Management Strategies Conference

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  • 22 Feb

Compared with the 2016 Drug Industry Association (DIA) Pharmacovigilance and Risk Management Strategies Conference, the 2017 conference in Washington, D.C. had a much better start. Although I was not at last year's conference, I read the epic testimonials of snowstorms, canceled flights, lockdowns and other interesting events, which were all very entertaining.

This year's DIA Pharmacovigilance and Risk Management Strategies Conference, which I attended, was less eventful, and yet, still full of encounters, lively discussions and as always, laughter.

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Why Your RBM System Should be SMART, Not Pretty

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  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
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"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
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Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (Yesterday)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
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Innovation Theater @DrugInfoAssn #DIA2017 Kicking off at 1. Perspectives on risk-based monitoring and TQM. https://t.co/mH6Npg0kD4
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RT @Xtalks: How Improving Site Payments Can Make You the Sponsor/CRO of Choice Tune in for this live webinar with @bioclinica https://t.co/…
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