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Time to Take Action and Make Risk-Based Monitoring a Reality

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  • 19 Jan

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

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What’s New with CDISC Standards?

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  • 16 Dec

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

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Evolution of the Clinical Data Management Role, 1994-2014

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  • 09 Dec

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

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3 Reasons to Share Data from Unsuccessful Clinical Trials

3 Reasons to Share Data from Unsuccessful Clinical Trials

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  • 25 Nov

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

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eSource: Are You On-Trend with Other Sponsors?

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  • 12 Nov

eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.

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Risk-Based Monitoring Versus Intelligent Monitoring

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  • 31 Oct

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

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eSource: Still in the Shallow End of the Pool?

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  • 23 Oct

Dipping a toe in the water is always easier than jumping right into something new.

I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.

Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.

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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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Meet the Bioclinica Safety and Regulatory Team: Sukrit Singh, Engagement Manager

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  • 07 Nov

Bioclinica's Safety and Regulatory Solutions division provides optimal drug safety, regulatory affairs and clinical services to CROs and sponsors. Our services are supported by our knowledgeable team members, who have experience in a wide variety of roles within the safety and regulatory sphere of clinical trials.

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Powerful Post-Approval Operational Strategies for the 21st Century

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  • 03 Nov

Post-approval research studies are vastly different from pre-market studies designed for the registration of a new drug or device. In the white paper "One Size Doesn’t Fit All": Applying an Innovative Mindset to Post-Approval Research, I outline these differences and illustrate why companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifically designed for and more relevant to post-approval research.

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3 Considerations When Implementing Risk-Based Monitoring Software

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  • 02 Nov

With regulatory agencies placing greater emphasis on risk-based monitoring (RBM) in clinical trials, the use of tools for RBM has become more and more crucial to success within the industry. If you're considering adopting an intelligent monitoring solution or if you're in the early stages of implementing such a tool, it's important to set yourself up for success early on by keeping a few things in mind. In my experience working with customers to implement Compass, I've learned a few key criteria that companies should consider to ensure RBM success.

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Trends in Asia Drug Development Market

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  • 01 Nov

Innovation and Harmonization on the Rise

As R&D costs continue to hit new heights and domestic participation in clinical trials wane, more and more biopharmaceutical companies are seeking ways to mitigate costs and access new patient populations. Over the past decade, these driving market forces have contributed to a sharp rise in R&D activities, pharmaceutical market size, and the number of clinical trials conducted in Asia.

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