Dan Beaudry, market owner for risk-based quality management (RBQM) at CluePoints, explains how regulatory shifts and AI-driven tools are transforming clinical trial data oversight. With ICH E6(R3) introducing risk-based approaches and the FDA signaling growing acceptance of algorithmic support, sponsors and CROs are operationalizing RBQM with adaptive site monitoring, automation, and predictive analytics. According to Beaudry, the future of clinical trial data will be defined by connected intelligence platforms that make oversight proactive, traceable, and inspection-ready.
