RBQM & Change Management: The Marriage We Keep Avoiding

About this session

Sponsored by CluePoints. Despite more than a decade of regulatory endorsement, RBQM adoption remains uneven—not because of technology limitations, but because of weak change management. While 96% of trials now include at least one RBQM component, execution-stage adoption lags behind planning, and 100% SDR/SDV still dominates many studies. This session challenges the industry’s “software-first” reflex and argues that RBQM success depends less on tools and more on redesigning processes and truly engaging CRAs, investigational sites, and other sponsor teams in a people-centered transformation aligned with ICH E6(R3)’s risk-proportionate vision.

Speaker

• FB

  Frederic Blais

  RBQM Lead, Strategic Consulting · CluePoints

  Speaker