CASE STUDY Embracing a Risk-based ApproachEmbracing a Risk-based Approach Regions Global STUDY DESCRIPTION A Phase III, open label, randomized, controlled, multicenter study to assess the safety and efficacy of the Study Drug monotherapy versus the physician’s choice to treat platinum-sensitive relapsed ovarian cancer. Study Duration 84 weeks No. of Clincial Sites 110 Patient Population 266 This was the first global study at PRA Health Sciences to adopt an adaptive trial management and monitoring (ATMM) model. The team used our Adaptive Monitoring Assessment Tool (AMAT), which was designed using the Risk Assessment and Categorization Tool (RACT) tool developed by TransCelerate, to identify critical data that required source data verification (SDV) and critical processes that req

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