CluePoints, the sponsor of RBQMLive and provider of statistical and AI-driven software solutions, has announced the full agenda and expert speaker line up for the 4th annual RBQMLive.
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RBQMLive, taking place on Thursday, 25th September, 2025, is a free virtual event, that unites industry experts, clinical trial specialists, and the wider industry to share insights, education and discuss the acceleration of RBQM. The free event will profile discussions on the return on investment of RBQM, the impact of recent regulatory updates and the implementation of AI.
Following the success of last year’s event, which drew in over 1,500 attendees from more than 290 organisations, RBQMLive 2025 is set to deliver even greater value with fresh opportunities and practical learning.
Highlights from RBQMLive 2025 will include:
- A keynote address from Ken Getz, executive Ddrector and professor, and Abigail Dirks, data scientist, Tufts Center for the Study of Drug Development. Key topics discussed will include the fundamentals of RBQM and net present value (NPV) analysis, understanding how the principles of ICH E6(R3) align with RBQM, the measurable financial and operational benefits of RBQM implementation and practical strategies for implementing RBQM into organisations. Ken Getz and Tufts CSDD will also present new data modelling that provides a comprehensive analysis of the ROI of RBQM.
- Decoding ICH E6(R3): From Principles to Practice: with Cris McDavid, senior director, global clinical operations at Parexel, Dawn Anderson, managing director, life sciences clinical transformation Leader at Deloitte, and Leonie Christianson, business consultant at Syneos Health. This session allows delegates to hear sponsor and CRO perspectives on interpreting the new principles, evolving quality strategies, and embedding RBQM and integrated data review into trial operations. The discussion will explore practical approaches to implementation, collaboration, and staying ahead of regulatory expectations.
- Harnessing AI for Risk-Based Quality Management: Current Innovations and Future Directions: This session delves into the practical applications of AI in RBQM and explore strategies for effective implementation.
Richard Young, chief strategy officer of CluePoints, said: “CluePoints is proud to be the premier sponsor of the 5th annual RBQMLive. With the release of the new ICH E6 (R3) guidance, RBQM and integrated data review are now at the forefront of trial operations and regulatory approval. We look forward to hosting this educational event where industry leaders discuss the capabilities of the approach and the future of RBQM.”