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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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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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2016 CDISC International Interchange: Standards, Metadata and the FDA

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  • 13 Oct

The last week of September, I had the opportunity to be a chair on the EHR/MDR session at the 2016 CDISC International Interchange in Maryland. I always enjoy being involved with the CDISC Interchange; it is inspiring to see all the people who are passionate about submitting quality standardized data to the FDA to make better lives for us all.

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Biomarkers for Alzheimer's Disease – Where are we now and Where are we going?

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  • 04 Oct

Last July, the Alzheimer's disease community gathered in Toronto for the Alzheimer's Association International Conference (AAIC) to share the latest advances in AD research and clinical trials.

Dementia is a global health issue as it affects over 45 million people worldwide and is recognized as a public health priority by the World Health Organization (WHO). Alzheimer's disease (AD) is a fatal degenerative brain disease and is the most common cause of dementia, accounting for an estimated 60 to 80% of cases1.

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4 Considerations for Choosing Key Risk Indicators (KRIs)

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  • 14 Sep

As a project manager and subject matter expert for Bioclinica's Compass RBM software, I've seen more and more companies turning to intelligent monitoring tools to track site performance and put their risk-based monitoring strategy into practice. When setting up a tool such as Compass, it's essential to choose the most important aspects of your trial to track in order to monitor site performance and identify areas on which to focus the most attention.

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6 Advantages of an Agile Approach to Interactive Response Technology (IRT)

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  • 13 Sep

In clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.

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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
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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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