The Premier
RBQM Industry Event
The Premier RBQM Industry Event
Join us Virtually
What’s RBQMLive?
Our Founder &
Sponsor: CluePoints
Our Founder &
Sponsor: CluePoints
Calling all Clinical
Trial Professionals!
Save the Date: September 25, 2025.
Your RBQM Guides
Abigail Dirks
Dawn Anderson
Leonie Christianson
Ken Getz
Cris McDavid
SESSION #1
Keynote Presentation
Time: 9:00-9:45AM
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
Executive Director & Professor, Tufts CSDD
Data Scientist, Tufts CSDD
SESSION #2
Panel
Time: 9:45-11:00AM
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
Senior Director, Global Clinical Operations, Parexel
Panelists
Managing Director, Life Sciences Clinical Transformation Leader, Deloitte
Business Consultant, Syneos Health
SESSION #3
Panel
Time: 11:00AM-12:00PM
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 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.
Key Topics
- AI Integration in RBQM: Explore how AI enhances RBQM by improving protocol design, risk identification, and trial efficiency.
- Real-World Applications: Learn from case studies showcasing the benefits and challenges of AI-driven RBQM in practice.
- Change Management Strategies: Discover how to effectively manage the shift to AI-powered RBQM through stakeholder engagement, training, and issue resolution.
- Future Trends: Get a forward-looking view of AI’s role in RBQM and how to prepare for upcoming innovations and methodologies.
Top Reasons to attend RBQMLive 2025
RBQMLive 2025 “What to expect” Guide
