In this episode, host Manny Vazquez is joined by Noeleen Turner, head of clinical data management at UCB, and Anna Hayes, senior director of clinical data management at Veramed.

Using their breadth of experience and passion for a people-focused approach to clinical trial advancement, together they dive into hot topics like risk-based data management, the intricacies of change management in clinical data, and the growing importance of endpoint-driven design.

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

Brian Johnson, former head of R&D technology at Takeda, now consultant, shares his unique perspective on a topic that’s top-of-mind for many: how do you introduce new technologies and processes without alienating the people who need them most?

He and Manny also tackle the critical issue of health equity, examining how technology can help diversify clinical trials and, in turn, create a more equitable future for all. Join us as we explore the business case for change and the crucial steps needed to unstick the industry from its current trajectory.