New research demonstrates RBQM-enabled trials achieve up to 23x ROI and 19% shorter phase durations, providing the industry's first quantitative business case for risk-based oversight in clinical development
WAYNE, Pa., July 7, 2026 /PRNewswire/ -- CluePoints, provider of leading statistical and AI-driven software solutions, has welcomed publication of its research providing quantitative evidence on the financial value of risk-based quality management (RBQM) in clinical development. The paper, co-authored by experts from CluePoints and researchers from the Tufts Center for the Study of Drug Development (CSDD), appears in the latest edition of Therapeutic Innovation & Regulatory Science (TIRS).
The study addresses a long-standing gap in the industry: while RBQM has gained increasing acceptance as an operational framework aligned with ICH E6(R3), quantitative evidence on its financial impact has been limited. To address this gap, the analysis combined real-world RBQM data from 18 oncology trials conducted on the CluePoints platform with published/proprietary oncology benchmarks maintained by Tufts CSDD to model financial value across clinical development phases.
Tufts CSDD analysis derived two primary financial measures: (1) Clinical trial-level ROI based on the direct financial return from RBQM in individual trials due to monitoring-cost efficiencies and shorter trial durations; (2) Development-program level ROI based on the risk-adjusted financial value of RBQM across the broader oncology development pathway, accounting for costs, timelines, probability of success, and discounted commercial performance.
Key findings include:
- RBQM-enabled trials were associated with 8%-19% reductions in clinical phase durations.
- At the clinical trial level, estimated financial returns ranged from $3.2M in phase 1 to $18.9M in phase 3, corresponding to 6x - 23x ROI multiples.
- At the development-program level, eNPV gains ranged from $3.8M in phase 1 to $13.8M in phase 3, corresponding to 4x-14x ROI multiples.
- The largest contributor to financial value was time savings, reinforcing that the strategic value of proactive, data-driven oversight extends beyond monitoring-cost reduction alone.
The paper was authored by Sylviane de Viron, PhD, and Kenneth McFarlane from CluePoints, alongside Abigail Dirks and Kenneth Getz, from Tufts CSDD.
Kenneth McFarlane, VP Strategic Consulting, and Sylviane de Viron, PhD, Data & Knowledge Manager, CluePoints: "For many sponsors, the question is no longer whether RBQM is aligned with regulatory expectations or good clinical practice - it is how to justify investment and scale adoption across portfolios. What is powerful about this study is that it translates RBQM impact into the language of clinical development decision-making: time, cost, ROI and portfolio value. The fact that most of the financial value was driven by time savings is especially important, because protecting development timelines is one of the most strategic levers sponsors have."
Broader benefits of RBQM-supported oversight discussed in the study and supporting literature include:
- Improved data quality oversight and earlier risk detection.
- Optimized monitoring-resource allocation.
- Increased development efficiency and speed.
- Enhanced portfolio productivity.
Abigail Dirks, MS, Senior Data Scientist, Tufts CSDD and primary author of the TIRS manuscript added: "The industry has long recognized the quality and oversight rationale for RBQM, but adoption decisions also rely on quantified operational and financial value. This study provides an empirical evidence-based approach to estimating that value. Importantly, the analysis modeled investment, operating impact and monitoring-cost and time-related savings. Other areas such as reduced rework, improved data integrity, inspection readiness, and training costs were not included in the model. Applying this methodology to a company's own portfolio and experience can provide tailored insight into the value that RBQM can deliver."
Read the full paper in the latest edition of TIRS here.
To learn more about CluePoints' award-winning solutions, please visit cluepoints.com.
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.
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