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TransCelerate BioPharma Inc. Reveals Collaborative Methodology for Risk-Based Monitoring of Clinical Trials
Date:6/3/2013

PHILADELPHIA, June 3, 2013 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate"), an independent non-profit organization focused on accelerating the development of new medicines, today released a position paper outlining a methodology for risk-based site monitoring ("Risk-Based Monitoring" or "RBM") that could significantly modernize and streamline the way studies are conducted and monitored.  The RBM position paper reflects TransCelerate's collaborative approach to improve speed, efficiency and capabilities in bringing new therapeutics to patients.  With the release of the paper, the now sixteen-member organization delivers the first major milestone of its five clinical trials initiatives.

When it launched in September 2012 – founded by major healthcare, pharmaceutical and biopharmaceutical companies – TransCelerate chose to focus on five initiatives related to clinical trial efficiency.  Specific to the Risk-Based Monitoring initiative, the organization's goal was to establish a common approach to high-quality, risk-based site monitoring to enhance patient safety, ensure the quality of clinical data, and create efficiencies.

"Biopharmaceutical companies often spend an extraordinary amount of effort monitoring clinical trials – data from each patient, for every study, at every global site, is reviewed – yet, there isn't much evidence to indicate that this level of review is effective at identifying systemic errors or substantially improving the quality of data gathered," said Dalvir Gill , PhD, Chief Executive Officer of TransCelerate.  "Despite this, monitoring approaches have remained unchanged.  In this position paper, we have outlined a methodology – procedures, algorithms,
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SOURCE TransCelerate BioPharma Inc.
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