Thanks to ICH E6(R2), the guideline for Good Clinical Practice, and other regulatory guidance, sponsors and CROs are motivated to apply risk-based monitoring (RBM) strategies to their clinical trials. The fact that the non-profit, TransCelerate, recently updated its Key Risk Indicators (KRI) library is an important indicator that RBM approaches are gaining traction.
(PRWeb April 03, 2019)
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