Sponsored by CluePoints
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). We thank our incredible speakers and the hundreds of attendees who joined us to make this year’s event so valuable. We’re proud to continue shaping the future of RBQM together, and we’re already looking forward to what’s next…
Sponsored by CluePoints
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). We thank our incredible speakers and the hundreds of attendees who joined us to make this year’s event so valuable. We’re proud to continue shaping the future of RBQM together, and we’re already looking forward to what’s next…
Join us Virtually
September 25th
ON-DEMAND RECORDINGS
Couldn’t Join Us Live?
Don’t worry. We’ve got you covered. This year’s sessions tackled some of the industry’s biggest priorities: quantifying the ROI of RBQM, decoding ICH E6(R3), and harnessing AI to transform clinical trials. Dive into the on-demand recordings and catch every insight, case study, and practical strategy.
Behind the scenes
Our Founder &
Sponsor: CluePoints
RBQMLive is made possible by the collective energy of its esteemed speakers, dedicated attendees, and CluePoints, the event’s proud founder and sponsor. As the premier provider of RBQM solutions, CluePoints continues to push the boundaries of what’s possible in clinical trials. It’s only natural that we bring the best of the best together here to collaborate, share expertise, and shape the future of RBQM.
Behind the scenes
Our Founder &
Sponsor: CluePoints
RBQMLive is made possible by the collective energy of its esteemed speakers, dedicated attendees, and CluePoints, the event’s proud founder and sponsor. As the premier provider of RBQM solutions, CluePoints continues to push the boundaries of what’s possible in clinical trials. It’s only natural that we bring the best of the best together here to collaborate, share expertise, and shape the future of RBQM.
Call for Speakers: RBQMLive 2026!
Join The Conversation
Do you have a fresh take on RBQM, RBDM, AI in clinical trials, or global regulatory trends? We want to hear from you. We’re now seeking visionary speakers for 2026, who can lead discussions, present data, demonstrate real-world case studies, and push the boundaries of what’s possible in trial quality.
Your RBQM Guides
We’re deeply grateful to our expert speakers for sharing their knowledge and perspectives. Special thanks to leaders from Tufts CSDD, Parexel, Deloitte, Syneos Health, and Veeva for delivering cutting-edge insights that are already driving meaningful change across the industry.
Abigail Dirks
Data Scientist, Tufts Center for the Study of Drug Development
Dawn Anderson
Managing Director, Life Sciences Clinical Transformation Leader, Deloitte
Leonie Christianson
Business Consultant, Syneos Health
Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development
Cris McDavid
Senior Director, Global Clinical Operations, Parexel
Drew Garty
Chief Technology Officer, Veeva
SESSION #1
Measuring the Impact: Quantifying the ROI of RBQM
Keynote Presentation
Keynote Presentation
For years, the industry has embraced RBQM as a smarter, more efficient approach to clinical trial oversight. But what’s the measurable return? In this keynote, experts from the Tufts Center for the Study of Drug Development (CSDD) 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.
Key Topics
- Introduction to RBQM & NPV Analysis: Learn the basics of RBQM and how NPV analysis can quantify its ROI and operational value.
- New Data Modeling Insights: Discover new data models showing the ROI of RBQM using real-world data and case studies.
- Linking RBQM to ICH E6(R3) Principles: Understand how RBQM aligns with ICH E6(R3) guidelines to enhance trial quality and efficiency.
- Financial & Operational Value: Explore the measurable ROI of RBQM through cost savings, faster trials, better data, and improved patient safety.
- Practical Implementation Strategies: Discover actionable steps and tips for successfully integrating RBQM into clinical trial processes.
Speakers
Ken Getz
Executive Director & Professor, Tufts CSDD
Abby Dirks
Data Scientist, Tufts CSDD
SESSION #2
Decoding ICH E6(R3): From Principles to Practice
Panel
Panel
What does ICH E6(R3) mean for clinical trial oversight, and how are leading Sponsors and CROs preparing for it? This session provides a dual perspective on interpreting the new principles, 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.
Key Topics
- Understanding ICH E6(R3) Principles: Learn the key updates of ICH E6(R3) and how they enhance clinical trial oversight through a risk-based approach.
- Sponsor & CRO Perspectives: Hear how Deloitte, Washington Health Strategies Group, and Syneos Health interpret ICH E6(R3) and are adapting quality systems.
- Evolving Quality Strategies: Explore how RBQM and integrated data review are embedded into trial operations to align with ICH E6(R3).
- Practical Implementation Approaches: Discover real-world strategies for implementing ICH E6(R3), including change management and digital tool adoption.
- Collaboration & Regulatory Expectations: Understand the need for Sponsor, CRO, and regulatory collaboration for ongoing compliance.
Moderator
Cris McDavid
Senior Director, Global Clinical Operations, Parexel
Panelists
Dawn Anderson
Managing Director, Life Sciences Clinical Transformation Leader, Deloitte
Leonie Christianson
Business Consultant, Syneos Health
SESSION #3
Harnessing AI for Risk Based EVERYTHING: Current Innovations & Future Directions
Panel
Panel
AI has become a pivotal tool in enhancing data quality, streamlining processes, and mitigating risks in clinical trials. This insightful session will delve into the practical applications of AI in RBQM and RBDM, before exploring how these two concepts come together fast. It’s designed for professionals looking to leverage AI to enhance their RBQM and RBDM processes and ensure regulatory compliance while improving trial outcomes.
This session will focus on real examples, describing not just the theory but the practical implementation that stems from connected thinking and connected delivery.
Connect your data. Clarify your signals. Coordinate action.
Key Topics
- AI Integration in RB Everything: Explore how AI enhances risk-based approaches by improving protocol design, risk identification, data cleaning, operational management, oversight and trial efficiency.
- Real-World Applications: Learn from case studies showcasing the benefits and challenges of AI-driven RB Everything in practice.
- Change Management Strategies: Discover how to effectively manage the shift to AI-powered RB Everything through stakeholder engagement, training, and issue resolution.
- Future Trends: Get a forward-looking view of AI’s role in RB Everything and how to prepare for upcoming innovations and methodologies
Speaker
Drew Garty
Chief Technology Officer, Veeva
More from Previous Years of RBQMLive…
