The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
Realizing the potential of RBM requires early planning, analytical expertise, sophisticated tools and process adaptability. Deep cross-functional expertise early in the trial process enhances the ability to assess overall risk, define critical data and processes, develop an integrated plan for addressing risk, and execute a monitoring plan that meets the trial’s unique requirements.