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Strong Clinical Operations for Enhancing Oncology Trials: Benefits of an Imaging Core Lab

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  • 28 Aug

The landscape of oncology drug development continues to evolve with shortened clinical trials, expedited drug development processes and the use of combined clinical and medical imaging data for patient management.  Advances in imaging and other technologies enable real time assessment of clinical data, providing sponsors with a tool for making rapid go/no go decisions regarding their compounds. Implementing and optimizing these advances can be challenging.

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Drug Supply Shortages in Clinical Trials, Part 3

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  • 15 Aug

Final installment in a three-part series on drug supply shortages in clinical trials with BioClinica's Trident IRT Team.

If you've been following this blog series on drug shortages, you know why it's so important to stay on top of clinical trial drug supply and the potential impact on clinical trials when shortages do occur: subject loss, lowered enrollment, budget escalation, delays and even study discontinuation.

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Drug Supply Shortages in Clinical Trials, Part 2

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  • 11 Aug
In this blog, we'll see where drug shortages create impacts and what some of the most common root causes are. Coming soon in Part 3 in this series, I'll share some real-life examples of trials where BioClinica was called into rescue mode. So stay tuned and you may pick up some tips to steer clear of drug shortages in your own program.
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Drug Supply Shortages in Clinical Trials, Part 1

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  • 05 Aug

John Burns, a member of BioClinica's Trident IRT team, was asked to present on drug shortages in clinical trials as part of a panel discussion at DIA. In it, he outlined examples of preventable causes and shared case studies showing what happens when things go awry.  Here is Part 1 in a three-part blog series recapping his discussion.

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eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 2

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  • 01 Aug

As promised in my last blog, here is the re-cap about Electronic Source Data in Clinical Investigations: Regulatory Considerations, a session presented by the FDA during the DIA annual conference.

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Central Endoscopic Reads in Inflammatory Bowel Disease Clinical Trials: Dr. Harris Ahmad explains the value of an Imaging Core Lab

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  • 28 Jul

Physicians, pharmaceutical companies and sponsors designing and implementing clinical trials of experimental therapies for inflammatory bowel disease (IBD) face unique challenges, including the use of a video component for assessing mucosal healing and the trend toward centralization of endoscopic evaluations. Furthermore, study design in IBD trials can vary significantly with regard to reader paradigms, approaches for assessing reader variability, and adjudication processes.

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eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

eSource Data in Clinical Investigations: FDA Clarifies Guidance on Regulatory Considerations Part 1

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  • 24 Jul

Despite the 8:00 AM session start time on Day 2 of the DIA Annual Conference in beautiful San Diego, California, study professionals packed the hall to hear FDA representatives speak on Electronic Source Data in Clinical Investigations: Regulatory Considerations.

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Bone Safety Studies for Diabetes Trials: A Q&A with Dr. Colin Miller

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  • 17 Jul

Later this month, Colin Miller, PhD, CSci will give a webinar focused on imaging endpoints for fracture risk assessment in clinical trials for diabetes drugs. As a preview to his webinar, I sat down with Colin to discuss the current regulatory landscape surrounding the safety of diabetes drugs and newer approaches that clinicians are using to monitor skeletal integrity.

1. What are some of the types of drugs that are available for treating diabetes?

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Data Management at Isis Pharmaceuticals

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  • 16 Jul

"Isis Pharmaceuticals has one of the most efficient data management departments for clinical trials I have ever seen." This is how Rich Murg, BioClinica Business Development Director, introduced the Isis Pharmaceuticals session led by Joan Baily during the recent BioClinica Global User Conference. That's saying a lot as Rich has met with many data management departments over the past eight years, assisting pharma companies and CROs with eClinical Solutions.

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How Endo Pharmaceuticals Achieved Rapid Study Start Up with a "Killer Collaborative UAT" for EDC

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  • 25 Jun

In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred. Specialized technical skills are vitally important and they become ever more valuable when the people who possess them come together to work on solutions in a facilitated, collaborative environment.

The Challenge

We presented BioClinica with a challenge in October 2013:

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Extremely Large Databases (XLDB) Healthcare Workshop Applications in Medical Imaging

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  • 13 Jun

I was recently invited to attend the XLDB workshop at my alma mater Stony Brook University. The two day workshop brought together experts from industry and academia to explore the application of advanced large scale data analytics to the healthcare sector. Many of the presentations were focused on big data technologies and innovative solutions for leveraging extreme scale data sets to positively impact patient outcomes and efficiency in the healthcare system.

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Are You Monitoring Blood Pressure in a Clinical Trial?

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  • 19 May
I recently gave a webinar focused on the implementation and benefits of using remote cardiovascular monitoring (telemonitoring) for clinical trials. Remote monitoring provides a promising patient management approach that produces increased data reliability, availability and early trend analysis and patient compliance with trial protocols. As a companion to my webinar, here are three considerations for clinical trial sponsors when establishing an approach to identifying a blood pressure response (safety or efficacy endpoint) and selecting a blood pressure monitoring method for their study.
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Questions to Help You Automate the Financial Lifecycle of Your Global Clinical Trials

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  • 18 Aug

During my years in the healthcare 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.

I continue to receive questions regarding our software and automating the financial lifecycle of global clinical trials. I'd like to address some key questions in this blog post so that everyone can benefit from the feedback.

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Risk-Based Monitoring Cost Savings: The Icing on the Cake Not the Cake Itself

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  • 16 Aug

Reducing monitoring costs continues to be the primary driver to adopting risk-based monitoring (RBM). But should that be the leading metric?

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Stronger Through Collaboration: A new wave of eHealth Solutions

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  • 15 Aug

Learning about new technologies and thinking strategically about their application in life sciences to ultimately benefit patients is what motivates me. This makes my role at Bioclinica a perfect fit as I get to partner with developers of innovative patient-centered applications from around the world for our eHealth App xChange.

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Bioclinica's Research Network Goes Global with Compass Acquisition

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  • 12 Aug

Bioclinica's extensive Research Network of full-service clinical study sites – already located in Asia, Europe, and Latin America – achieved a global status with the recent acquisition of Compass Research. As reviewed in the CenterWatch Weekly publication, the acquisition will expand Bioclinica's Research Network into the U.S., providing a true global site network for pharmaceutical companies engaged in clinical research.

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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