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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

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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Is Your Clinical Trial Payments System Scalable?

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  • 25 Aug

At Bioclinica, we often talk with CROs who have outgrown their site payment systems. Whether they're using spreadsheets or a manual, homegrown system, as the number of trials they're conducting increases, CROs often find that their current systems can't keep up.

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Elizabeth Thiele

Patient Recruitment and Retention for Healthier Studies

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  • 18 Aug

Finding patients to participate in clinical trials and keeping them engaged for the duration are two of the greatest challenges in the clinical development process. Yet, as our President and CEO John Hubbard sees it, "Every major challenge is also an opportunity to improve the clinical development process." To overcome such hurdles, we as an industry must become more efficient in conducting clinical trials while simultaneously keeping a keen focus on the patient.

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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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