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The Four Pillars of Intelligent Monitoring

Raising Clinical Trial Intelligence

Risk-Based Monitoring (RBM) Evidence Mounting

In the recent paper from industry consortium TransCelerate BioPharma, Inc., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (available here) issued in November 2014, RBM gains further support as evidence from actual clinical trials is presented corroborating earlier findings cited by the US FDA and EMA.

When it comes to clinical trial oversight, both regulatory agencies have vocalized a preference for greater use of centralized and off-site monitoring and mechanisms taking advantage of technology-enabling tools as opposed to what's traditionally been done – 100% SDV and frequency-based onsite monitoring.

Compass technology was indeed founded on the premise that SDV alone is not enough to ensure quality and performance in clinical trials. It emphasizes a holistic approach to RBM, taking into account both qualitative data (risk assessment, monitor feedback, site feedback) and quantitative data (key clinical trial data and operational metrics). This gives the study sponsor a complete picture of site performance.

Raising Clinical Trial Intelligence

Here at BioClinica we take a unique approach that employs quality and risk management strategies, as described in this earlier blog, Why Intelligent Monitoring is Even Smarter than Risk-Based Monitoring. Equipped with the meaningful information in a digestible format, sponsors are able to consistently take the right action.

Four primary activities underpin the Intelligent Monitoring approach, summarized below.

Embracing New Thinking in Monitoring

With the evidence already there, it's time to retire old thinking about source data verification and its connection to clinical trial quality. Moving toward more intelligent monitoring methods will bring into view the complete site performance picture across your trial. Compass puts under-utilized data that's already at clinical trial teams' fingertips to work in powerful new ways.

Equipping sponsors with clinical trial intelligence in a digestible format enables sponsors to spot problems early and take corrective action – and ideally – prevent them from happening in the first place. Among the potential benefits are better overall clinical trial performance and reduced risk.

With mounting evidence about the efficacy of risk-based monitoring (RBM) to raise overall quality in clinical trials, it's an exciting time to be out front with the Compass technology solution. To learn more about this innovative technology, contact me at CourtneyMcBean@BioClinica.com.

Overcoming Barriers to Risk Based Monitoring

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle 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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