Wayne, PA – October 1, 2026: CluePoints, provider of leading statistical and AI-driven software solutions, has announced the exciting agenda for the 6th annual, award-winning event RBQMLive.

RBQMLive 2026 is the virtual landing space for all clinical researchers involved in accelerating the delivery of RBQM across the industry. This year the event will take place through the mornings of 7-8^th October.

This year’s agenda tackles the four questions RBQM leaders are wrestling with right now: what operational maturity actually looks like under ICH E6(R3), how to prove RBQM's business value, where AI belongs in clinical operations, and how to design quality in from the protocol stage.

Highlights include:

Day 1

• RBQM at a Turning Point: From Adoption to Operational Maturity - Ken Getz — Executive Director & Professor, Tufts CSDD. This session will explore how RBQM has achieved widespread adoption and how companies and organizations are operationalizing risk-based approaches. The keynote will examine where the industry stands today, why expectations and practices have shifted, and how regulatory tailwinds (e.g., ICH E6(R3)) and the rapid emergence of AI and real-world oversight, are redefining the RBQM landscape.

• Beyond Adoption: Proving the Value of a Mature RBQM Program - Miguel Valenzuela — Director, Clinical Risk & Analytics, Alnylam. Jamie O'Neill. Demi You — Head of RBM, Sanofi. This discussion will explore how leading sponsors are advancing their RBQM programs, overcoming common barriers, and building mature, scalable risk management practices. Panelists will share lessons learned around governance, organizational change, cross-functional collaboration, and, critically, how they build and defend the business case: the metrics that convince finance and quality leadership that RBQM delivers a measurable return. 

  Day 2

• Trusted AI in Clinical Operations: From Automation to Decision Intelligence - Cris McDavid — Director, Global Clinical Operations RBQM, Parexel. Brian Barnes — Director, Risk-Based Quality Management, BioNTech. Sas Maheswaran — Market Owner, CluePoints. This session will explore how organizations are implementing AI responsibly while improving efficiency, consistency, and decision-making. Speakers will discuss governance, validation, transparency, auditability, continuous monitoring, and what sponsors need from AI vendors to confidently integrate AI into regulated clinical processes.
• Designing Quality: From Inspection Readiness to Predicting Risk Before First Patient - Kris Lupaert - Inspection Excellence Lead, Merck KGaA. Tom Whitman - Associate Director, Quality Systems & Technology, Biogen. This session will explore how organizations are shifting from reactive compliance to predictive quality management, using historical study data and protocol intelligence to identify emerging risks before they affect execution, and increasingly to design risk out at the protocol stage. As protocols become more complex, panelists will discuss how early risk visibility improves planning, oversight, and regulatory confidence.

RBQMLive 2026 takes place virtually on the 7-8^th of October. Visit RBQMLive 2026 to register and view the full agenda.

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About CluePoints

CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6(R3), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.

Media Contact

Sophie Beattie – Discovery PR, on behalf of CluePoints

Email: sophie@discovery-pr.com