ICH E6(R3): Shifting the Paradigm from Process to Purpose

In this episode, we pull back the curtain on the monumental effort required to reshape global clinical trial standards. Manny and guests Lisbeth Bregnhoj and Cheryl Grandinetti explore why ICH E6(R3) is the catalyst the industry has been waiting for. From the intense complexity of dialing in language across regional borders to the latest push for a truly risk-based approach to clinical trials, the discussion highlights: A shift in strategy: Why the industry is finally moving away from "one-size-fits-all" in favor of flexibility and high-level data governance Defining quality: Breaking down what Critical-to-Quality (CtQ) factors actually look like in practice and how to align that understanding between sponsors, service providers, and investigators The future of inspections: It’s not just a change for sponsors – regulators are also facing a major shift in how they harmonize inspection techniques in a risk-based world