About the Webinar 

Risk-Based Quality Management (RBQM) is now an established approach to clinical trial oversight and a core expectation under ICH E6(R3). Yet for many sponsors and CROs, one question has remained unanswered: what is RBQM actually worth?

• A new peer-reviewed study, published in Therapeutic Innovation & Regulatory Science (TIRS), provides the first quantitative assessment of the financial return of RBQM. Drawing on real-world data from 18 oncology trials conducted on the CluePoints platform and industry benchmarks from Tufts CSDD, the research models ROI at both the clinical trial and development program level across all clinical phases. 
• The findings are striking: RBQM-enabled trials demonstrated ROI multiples of up to 23x, eNPV gains of up to $13.8M at the program level, and 8-19% reductions in clinical phase durations. Time savings, not monitoring cost reduction, account for the majority of financial value generated. 
• Join the authors of the study as they present the findings live, discuss the methodology, and explore what this evidence means for sponsors and CROs looking to build the business case for RBQM, justify investment decisions, or scale adoption across their portfolio. 
• Whether you are evaluating RBQM for the first time, looking to demonstrate its value internally, or exploring ways to accelerate development efficiency, this session provides peer-reviewed evidence you can act on. 

During This Webinar You'll Learn

• About the first peer-reviewed quantitative evidence of RBQM's financial value — including how RBQM-enabled trials achieved up to 23x ROI and 19% shorter clinical phase durations based on data from 18 oncology trials. 
• Why time savings deliver greater financial value than monitoring cost reductions alone, and what that means for how organizations build and communicate the internal business case for RBQM investment. 
• How peer-reviewed ROI evidence can accelerate portfolio-wide RBQM adoption, giving sponsors and CROs objective, citable data to support investment decisions and organizational change. 
• How empirical evidence from a peer-reviewed, multi-sponsor oncology dataset can be applied to your own organization’s RBQM strategy and portfolio planning. 

Ready to quantify the value of RBQM?

Meet Our Speakers