This insight brief explores how digital transformation is reshaping Risk-Based Quality Management (RBQM) in clinical trials, with particular emphasis on clinical monitoring. It explains RBQM in practical terms, highlighting its role in proactively identifying, assessing, and mitigating risks to patient safety and data integrity. The brief outlines key drivers of change, including increasing trial complexity, decentralized designs, and growing data volumes. It describes how digital RBQM integrates data from multiple sources into centralized platforms, enabling real-time risk detection, advanced analytics, and targeted monitoring. Guidance is provided on customizing RBQM to fit individual trials, supported by seven best-practice principles. IQVIA emphasizes early partnership, cross-functiona

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