SCOPE Summit 2025: Richard Young Discusses Key Takeaways and the Future of RBQM

ACT: What key takeaways do you hope to share with industry leaders at SCOPE 2025, and how do you see Cluepoints shaping the future of RBQM?

Young: I think RBQM is becoming a much bigger opportunity. It's really about treating data as an entire ecosystem. It's not just individual data points now, it's the totality. It's about looking at patients, looking across patients, looking across studies, and data is the common element of that. For us, as we s we talk to different partners, customers, sponsors, it's really coming down to four pillars. Are you cost motivated? Are you time motivated? Are you resource motivated, or are you quality motivated? And everyone wants to say the politically correct answer, well, it's all four, but it can't be all four. You have to pick one. I’m not saying you sacrifice the others. What I'm saying is you're going to pick your priorities, and what we’re here to talk about is the fact that we are fueling all four.

Full Interview Summary: At SCOPE this year, the key objective is to advance the conversation around risk-based quality management (RBQM), transitioning it from a theoretical concept to an actionable reality. The conference provides a collaborative platform to discuss the evolution of RBQM, particularly in light of emerging technologies like AI, which were not even part of the industry's vocabulary a decade ago. The goal is to validate and expand discussions, ensuring that RBQM is implemented effectively across clinical trials.

A significant regulatory shift impacting RBQM is the imminent release of the updated ICH GCP E6(R3) guidelines. These changes are expected to transform how sponsors approach RBQM, potentially even redefining the concept of “risk” itself. Rather than being viewed as a negative factor, risk management could shift toward a more data-driven, informed decision-making process. These guidelines will influence aspects such as chain of custody and the integration of modern methodologies into trial management.

The future of RBQM is increasingly centered around data as a comprehensive ecosystem rather than isolated data points. Industry stakeholders are prioritizing different drivers—cost, time, resources, or quality—in their approach to RBQM. While all four factors are important, organizations must determine their primary focus to optimize decision-making. The industry is working toward a model where these priorities can be balanced more effectively, ensuring that clinical trials remain patient-centric while also meeting regulatory and operational goals.

Ultimately, SCOPE serves as a critical venue for shaping the future of RBQM, fostering discussions that drive innovation and efficiency in clinical research.