CASE STUDY Succeeding with a Risk-based Approach Adaptive Trial Management & MonitoringSucceeding with a Risk-based Approach Adaptive Trial Management & Monitoring STUDY DESCRIPTION A Phase III double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of Drug A in patients with moderate to severe chronic back pain Regions North America Study Duration 20-25 weeks No. of Clincial Sites 65 Patient Population 610 Treatment Period 13-20 weeks The initial study design specified 100% source data verification (SDV) monitoring with clinical research associates (CRAs) performing central monitoring activities. The central review process, combined with technological developments, offered an alternative, risk-based approach. As a result, PRA implemented an ad

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