Therapeutic Innovation & Regulatory Science
Health Decisions CEO Michael Rosenberg’s February 2014 article in DIA’s journal Therapeutic Innovation & Regulatory Science provides an objective account of the key considerations in making the transition to risk-based monitoring.
In the 2 years since publication of the European Medicines Agency’s ‘‘Reflection Paper on Risk Based Quality Management in Clinical Trials’’ and US Food and Drug Administration’s ‘‘Draft Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring,’’ the methodologies, products, and services for risk-based monitoring have proliferated and diversified. The biopharmaceutical industry can choose from a variety of general approaches and specific practices. This article provides a framework to assist biopharmaceutical companies in selecting and implementing a risk-based monitoring approach or selecting a service provider. The framework includes discussion of different approaches to source data verification but also discusses other important dimensions of risk-based monitoring: individualization of the monitoring approach for each study; error detection and correction, including but not limited to source data verification; real-time quality management; error prediction and prevention; and adoption and implementation.