OpenRBQM

OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM

Problem Statement

Risk-based quality management (RBQM) is a regulatory-recommended approach to detect and effectively manage risk in a clinical trial. While there is a significant body of literature describing RBQM implementation and best practices (1, 2), there are few publicly available open-source tools for RBQM available. Instead, commercial tools and custom company-specific RBQM implementations currently serve as the industry standard for RBQM implementation.