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Impact of FDA guidelines for risk based monitoring on clinical trials

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by Beroe Inc.
14 January 2014

Current clinical research methods allocate monitoring resources (primarily Clinical Research Associates (CRAs)) uniformly among the clinical trial sites. Through the use of existing and new technologies, risk-based monitoring is expected to allocate resources across clinical trials based on their level of risk while maintaining data quality and patient safety. This is expected to reduce the trial monitoring cost by 10-20%. Watch Beroe's Senior Research Analyst, Ashwini, as he discusses the Impact of FDA's final guidelines for risk-based monitoring (RBM) on clinical research and role of suppliers/partners in this space.

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