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7 Principles of eSource Use

7 Principles of eSource Use

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  • 17 Oct

As I write this, I’m on a return flight home to Philadelphia from Las Vegas where I attended the Annual SCDM conference. It was a great event and I’m pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource.

One session I’d like to tell you about is an eSource roundtable that was moderated by Linda King, Director of Global Data Delivery at Eli Lilly and Demetris Zambas, VP and Global Head, Data Management at Novartis. Representatives from CDISC, Merck, J&J, AssisTek, Quintiles, and Otsuka rounded out the expert panel.

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Response to TransCelerate’s Risk-Based Monitoring Paper: Technology Considerations to Enable Risk-Based Monitoring Methodology

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  • 30 Sep

Have you had a chance to read the latest TransCelerate paper on risk-based monitoring (RBM)?

If not, I highly recommend getting your eyes on Technology Considerations to Enable the Risk-Based Monitoring Methodology, published online in August on behalf of the Drug Information Association (DIA). This paper serves as a tremendous resource for any organization interested in new enterprise technology to help realize the advantages of risk-based monitoring.

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Highlights from the 2014 Osteoarthritis Imaging Workshop

Highlights from the 2014 Osteoarthritis Imaging Workshop

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  • 23 Sep

This summer, experts from academia, industry and regulatory sectors gathered in Reykjavik, Iceland for The International Workshop on Osteoarthritis Imaging (IWOAI) to discuss the latest advances related to imaging in Osteoarthritis (OA). Presentations at this conference centered on new imaging techniques and analytical methods for monitoring OA pathophysiology and evaluating imaging data from clinical studies.

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FDA Insights: A Video Series Featuring FDA Perspectives on Clinical Trials, Part 2

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  • 19 Sep
BioClinica's Jonathan Andrus sits down with FDA official Sean Kassim, Ph.D., to discuss FDA Audits, Cloud Computing, Mobile Technology, Risk-Based Monitoring, eSource, ePRO, and Other Compliance and Quality Topics in Clinical Trials. See the videos of their discussion here!
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FDA Insights: A Video Series Featuring FDA Perspectives on Clinical Trials, Part 1

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  • 17 Sep
BioClinica's Jonathan Andrus sits down with FDA official Sean Kassim, Ph.D., to discuss FDA Audits, eSignatures, Audit Trails, and Software Validation in Clinical Trials. See the videos of their discussion here!
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Compass Intelligent Monitoring – A First Look

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  • 15 Sep

It's been a real whirlwind of activity since the news BioClinica Acquires Blueprint Clinical was announced in June. Interest in Compass intelligent monitoring continues to snowball as word spreads among sponsors and CROs, large and small, all looking to move forward with a risk-based monitoring strategy.

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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

Real-Life Examples of Studies Hurt by Drug Shortages and Tips to Avoid

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

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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

Top 10 Ways to Avoid Drug Shortages in Clinical Trials

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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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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How Do You Get People to Join Clinical Trials? Show a Movie!

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  • 10 Aug

Many people don't understand what a clinical trial is or how one is conducted. This can make it hard to recruit and screen the hundreds and often thousands of patients necessary to find qualified individuals to participate in a given study.

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End-to-End Patient Engagement Is a Reality

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  • 09 Aug

Patient engagement is an ongoing challenge when conducting clinical trials. A recent article published in CenterWatch Weekly noted, "Experts point to problems with awareness, understanding, and trust among potential trial participants as well as providers that persists today. They also cite the disconnect between a patient's interest in participating in a trial and actually taking the next step to enroll.

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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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