A collection of R Packages designed for risk-based quality management (RBQM).
Risk-based quality management (RBQM) in clinical trials is a methodology that focuses on identifying, evaluating, and mitigating risks that could impact trial quality, patient safety, and data integrity. It shifts from a one-size-fits-all approach to a proactive, systematic, and adaptive strategy by prioritizing resources on "things that matter," such as critical processes and data points. This approach is advocated by regulatory bodies like the FDA and EMA and is rooted in the principles of Quality by Design (QbD) and Risk-Based Monitoring (RBM).