Advanced Clinical Trials and Clinical Research

Risk-Based Monitoring

Risk-based monitoring (RBM) offers a modern, data-driven approach to clinical trial oversight by focusing resources on the most critical areas of risk. This session explores the principles and methodologies behind RBM, including centralized monitoring, key risk indicators (KRIs), and targeted source data verification (SDV). Attendees will learn how to develop risk management plans, use statistical algorithms for site prioritization, and incorporate real-time dashboards for efficient decision-making. The session also addresses regulatory guidance from FDA and EMA on RBM adoption and common implementation challenges. Real-world case studies will illustrate how RBM can enhance trial quality, reduce costs, and maintain compliance while improving overall operational efficiency. This session is designed for clinical operations leaders, quality managers, and data scientists seeking to modernize their monitoring strategies through a risk-based lens.