The Premier
RBQM Industry
Event
This is where the brightest minds in clinical trials come together to push the boundaries of risk-based quality management (RBQM).
This is where the brightest minds in clinical trials come together to push the boundaries of risk-based quality management (RBQM).
Join us
October 7-8th
What’s RBQMLive?
Calling All Clinical Trial Professionals
Join The Conversation
2026 marks the sixth annual RBQMLive,
and the conversation keeps growing. Are you ready to be a part of it?
Save the Date:
October 7–8, 2026
Want to Speak at RBQMLive26 or Other CluePoints Events?
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Our Founder and Sponsor:
CluePoints created RBQMLive to give the RBQM community a dedicated space to learn, debate, and advance the science of risk-based quality management. As the founding sponsor, CluePoints brings together the brightest minds in clinical trials, independent of any commercial agenda.
2026 Agenda
RBQM at a Turning Point: From Adoption to Operational Maturity E8 and E11 Potential Expansion
Risk-Based Quality Management has achieved widespread adoption, but true operational maturity remains elusive. This keynote examines where the industry stands today, why expectations have shifted, and how regulatory expectations source, including ICH E6(R3), combined with the rapid emergence of AI and real-time oversight are redefining what “good” looks like.
Attendees will gain a clear perspective on the next phase of RBQM, and the organizational capabilities needed to succeed.
Speakers
Role, Organization
Role, Organization
Beyond Adoption: Proving the Value of a Mature RBQM Program
Organizations have largely implemented RBQM, but achieving measurable value requires moving beyond compliance toward operational excellence. This discussion explores 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.
Panelists
Role, Organization
Role, Organization
Role, Organization
Trusted AI in Clinical Operations: From Automation to Decision Intelligence
AI is rapidly moving from experimentation to practical application across clinical development. This session explores 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.
Discussion Topics
- Moving beyond automation toward intelligent decision support
- Maintaining human in the loop
- Regulatory expectations for AI validation and governance
- Explainability, audit trails, monitoring, and trusted AI
- Sponsor expectations for AI solutions, including transparency, data sources, integration, and oversight
Speakers
Role, Organization
Role, Organization
Role, Organization
Designing Quality: From Inspection Readiness to Predicting Risk Before First Patient
Inspection readiness is no longer about preparing for an audit. It is about continuously understanding and managing quality risk throughout a study. This session explores how organizations are shifting from reactive compliance to predictive quality management, using historical study data and protocol intelligence to identify emerging risk 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.
Discussion Topics
- Using historical data to predict operational and quality risks
- Risk out at the protocol stage, before first patient in
- Turning historical and protocol intelligence into earlier, more confident go/no-go decisions
- Continuous inspection readiness versus point-in-time preparation
- Enabling more predictable study execution through real-time quality insights
Panelists
Role, Organization
Role, Organization
Role, Organization
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