Quantifying the Net Financial Value of Deploying Risk-Based Quality Management

A recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that implementing risk-based quality management (RBQM) components in a Phase III oncology trial yielded net financial value of $13.8 million with 84% of the total value coming from time savings and efficiency and 16% coming from monitoring cost savings. The purpose of this article is to share our study findings, and to inform discussion and adoption of RBQM.

Background

Despite its introduction nearly fifteen years ago, and prior to encouragement by regulatory agencies in more recent years, RBQM has experienced slow adoption in drug development. A 2023 Tufts CSDD study found that approximately 57% of clinical trials were using RBQM components.Mixed cross-functional perceptions of RBQM’s value proposition and the lack of regulatory clarity were cited as primary reasons for low industry-wide adoption.

Release of the final ICH E6 (R3) guideline in January 2025 has now provided regulatory clarity regarding the use of RBQM. The guidance encourages a risk-based approach to manage the high and growing volume of data collected in clinical trials by prioritizing essential efficacy and safety data and mitigating issues proportionate to the risk posed to participant safety and data integrity.

A clear and quantified value proposition for deploying RBQM is less clear. A 2025 survey conducted among 41 sponsor companies who had implemented RBQM found that 42% reported seeing a positive ROI and 58% indicated that it was too early to tell. Those who indicated a positive ROI attributed it to fewer monitoring visits and less time during site visits. Although some qualitative evidence on the value proposition of RBQM has been gathered, virtually no quantitative assessment of RBQM’s impact has been performed. To address this gap, Tufts CSDD conducted a robust analysis to quantify the net financial value of implementing RBQM on an oncology drug development program.

Financial assessment methods

Two financial assessments were conducted—one that provides the estimated budget savings when RBQM is implemented at the study or clinical trial level and the other that quantifies the net financial value created by deploying RBQM across a product lifecycle. The latter assessment used the robust, and widely-recognized, expected Net Present Value (eNPV) approach. Net present value is defined as the after-tax, inflation- and risk-adjusted present-value of the future net cash flows for a drug or biologic that is granted regulatory marketing approval and is launched for sale in the marketplace. Value creation is derived from the eNPV delta between a traditional development program that did notuse RBQM components and a development program that did use RBQM components. Both the clinical trial and program-level assessments focused on the use of RBQM in oncology clinical trials as they represent the most active area in drug development.

To perform the assessments, Tufts CSDD compiled benchmark data on cycle times, costs and success rates from published sources including Drugs @ FDA, AdisInsight, Bio/Informa/QLS, Citeline, and Tufts CSDD’s approved drug and protocol databases. Sales data from approved oncology drugs and biologics was also gathered. Tufts CSDD collaborated with CluePoints to collect data on the investment required to implement, and the actual impact from, using RBQM components.

The implementation of RBQM is expected to reduce monitoring costs by avoiding 100% source data review and verification (SDR/SDV) and enable time savings through early identification of risks that avoid time-consuming protocol modifications or delays to study completion. These two key value drivers of RBQM—reduction in site monitoring resources and reduction in cycle time based on actual experience—were modeled.And, for the model, we assumed that the RBQM implementation had 10% SDV, with data quality assessments (DQA) and key risk indicators (KRIs) planned and applied during the trial.RBQM investment estimates were largely the cost to implement an RBQM software platform.

Actual experience showed that oncology clinical trials that deployed RBQM components had an estimated 9-18% decrease in site monitoring costs per phase and an 8-19% reduction in total time per phase compared to traditional clinical trials that had not implemented RBQM.

Quantifying RBQM’s net financial value

At the clinical trial level, under a 10% SDV scenario, monitoring expenditures were reduced by up to 18% compared with the conventional 100% SDV approach. Time savings ranged from 8% in Phase I to 19% in Phase III, translating to financial value that increased across the development continuum. These reductions in monitoring activity and cycle times resulted in total clinical trial-level financial gains ranging from $3.2 million in Phase I to $18.9 million in Phase III, with ROI multiples of 6.1× to 22.7× (see Table 1).

At the program level, the expected net present value (eNPV) analysis showed that RBQM can generate consistently positive financial value across phases and phase combinations. Program-level eNPV deltas ranged from $2.75 million to $13.83 million for single-phase implementations, with similar positive effects observed in multi-phase scenarios. The strongest economic impact was observed in Phase III, reflecting the large absolute cost of late-stage development and the greater financial consequences associated with delays or inefficiencies. Across all scenarios, time savings accounted for the majority (75%–96%) of total financial value (see Figure 1).

Other RBQM value drivers exist that were not included in either financial assessment. A major but less common area of substantial potential savings is in the case of a fraudulent site. RBQM deployments are likely to identify the issue earlier avoiding the high cost of addressing the issue later in the trial. RBQM can also enable insights for future operational decision-making that were not factored into the financial assessment. For example, data quality indicators throughout a study can help identify higher-performing sites for future site engagement. RBQM also has the potential to reduce the number of protocol deviations, improve data integrity, and improve inspection and regulatory outcomes. These benefits could not be quantified in the assessments.

Additionally, some RBQM deployment costs were not included in the financial assessments.Those associated with first time RBQM implementations, for example, including training, SOP updates, change management, data integration, central monitoring resourcing, and the cost of maintaining legacy monitoring processes.The cost of governance and vendor oversight also were not included in the assessments.

Implementation with regulatory clarity and quantified value proposition

The ICH E6 (R3) guidance provides the regulatory impetus to embrace RBQM. Tufts CSDD’s financial assessments provide quantification of the net financial benefits.The two financial assessments presented in this article not only provide quantitative measures of return-on-investment, but also provide methodologies that companies can apply to their own tailored financial assessments.

It’s important to note that the assumptions made in the eNPV model reflect benchmarks associated with large pharmaceutical company oncology development experience. The cost of capital, operating costs and other parameters will vary by company size.

The results of this initial study inform ROI assessment of RBQM deployments. But they are only the beginning. It is essential, that industry continuously gather and share actual experiences to further inform and refine our understanding of the value proposition of the wide variety of RBQM deployments supporting and helping to optimize drug development performance and quality.

Abigail Dirks, MS; and Kenneth Getz, MBA, Tufts Center for the Study of Drug Development, Tufts University School of Medicine