Expert Speaker Lineup announced for leading RBQM event
CluePoints, the premier sponsor of RBQMLive and provider of leading statistical and AI-driven software solutions, has announced the full agenda and expert speaker line up for the 5th annual, award-winning event, RBQMLive.
RBQMLive, taking place on Thursday, September 25th, 2025, is a free virtual event, bringing together the brightest minds in clinical trials to push the boundaries of risk-based quality management (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 organizations, 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 Director and Professor, and Abigail Dirks, Data Scientist, Tufts Center for the Study of Drug Development. For years, the industry has embraced RBQM as a smarter, more efficient approach to clinical trial oversight. But what's the measurable return? This keynote will unveil new data modeling that applies Net Present Value (NPV) analysis to RBQM implementation, offering a first-of-its-kind look at the financial and operational value of doing things differently. With links to ICH E6(R3) principles, this session provides a compelling case for investing in a more proactive, data-driven approach to quality.
— 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 provides a dual perspective on interpreting the new principles of ICH E6(R3), evolving quality strategies, and embedding RBQM and integrated data review into trial operations. Moderated by Parexel, 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: AI has become a pivotal tool in enhancing data quality, streamlining processes, and mitigating risks in clinical trials. This insightful session from Drew Garty, Chief Technology Officer, Clinical Data at Veeva Systems, will delve into the practical applications of AI in RBQM and explore strategies for effective implementation. It's designed for professionals looking to leverage AI to enhance their RBQM processes and ensure regulatory compliance while improving trial outcomes.
Richard Young, Chief Strategy Officer of CluePoints, commented: “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.”
RBQMLive 2025 takes place virtually on September 25th. Visit RBQMLive 2025 to register and view the full agenda.
About CluePoints
CluePoints is the premier Risk-Based Quality Management(RBQM) and Data Quality Oversight Software provider. We areleveraging the potential of Artificial Intelligence using AdvancedStatistics and Machine Learning to determine the quality,accuracy, and integrity of clinical trial data both during andafter study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R3),CluePoints is deployed to support central and on-sitemonitoring, medical review, quality risk management and todrive a holistic Risk-Based strategy in all trials. Coupled withthought leadership and consulting expertise to aid pre-studyrisk assessment, identification of risk controls and solutionimplementation, you now have everything you need to adherewith global regulatory guidance. The result is positive clinicaldevelopment outcomes, increased operational efficiency, lowercosts and reduced regulatory submission risk as part of theindustry paradigm shift to RBQM.
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SOURCE CluePoints
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