deniskatz

Maximizing Safety and Integrity in Orthopedic Clinical Trials with RBQM: A Strategic Approach by Denis Katz, MD Introduction Orthopedic clinical trials  characterized by complex surgical interventions, device-specific variables, and extended rehabilitation follow-ups are prime candidates for  Risk-Based Quality Management  (RBQM) . RBQM is an adaptive, data-driven quality framework that focuses oversight on what is most critical to participant safety and the validity of trial conclusions. In January 2025, ICH finalized the  E6(R3)  update to Good Clinical Practice, which explicitly embeds RBQM principles and encourages sponsors to integrate critical-to-quality thinking across the clinical development lifecycle. Understanding Risk-Based Quality Management RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is  proportionality : monitoring intensity and quality controls are aligned...

Maximizing Safety and Integrity in Orthopedic Clinical Trials  with RBQM: A Strategic Approach by Denis Katz, MD Introduction Orthopedic clinical trials  characterized by complex surgical interventions, device-specific variables, and extended rehabilitation follow-ups are prime candidates for Risk-Based Quality Management (RBQM) . RBQM is an adaptive, data-driven quality framework that focuses oversight on what is most critical to participant safety and the validity of trial conclusions. In January 2025, ICH finalized the E6(R3)  update to Good Clinical Practice, which explicitly embeds RBQM principles and encourages sponsors to integrate critical-to-quality thinking across the clinical development lifecycle. Understanding Risk-Based Quality Management RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality : monitoring intensity and quality controls are aligned to the risks tha...