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  3. Quantifying The Financial Return On Investment Of Risk-based Quality Management Implementation In Clinical Development.
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  3. Quantifying The Financial Return On Investment Of Risk-based Quality Management Implementation In Clinical Development.

Related Experiment Video

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Quantifying the Financial Return on Investment of Risk-Based Quality Management Implementation in Clinical

Abigail Dirks1, Sylviane de Viron2, Kenneth McFarlane3

  • 1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. Abigail.Dirks@tufts.edu.

Therapeutic Innovation & Regulatory Science
|June 25, 2026

View abstract on PubMed

Summary
This summary is machine-generated.

Risk-based quality management (RBQM) adoption is boosted by demonstrated ROI. RBQM improves clinical trial efficiency, reducing phase durations and costs, leading to significant financial returns.

Keywords:
Centralized monitoringClinical trial efficiencyExpected net present valueICH E6(R3)Oncology drug developmentQuality by designReturn on investmentRisk-based quality managementSource data verification

Related Experiment Videos

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Area of Science:

  • Clinical trial management
  • Pharmaceutical development
  • Quality management systems

Background:

  • Limited adoption of risk-based quality management (RBQM) principles in drug development due to a lack of quantitative return on investment (ROI) evidence.
  • Stakeholders require data-driven justification for implementing RBQM.

Purpose of the Study:

  • To estimate the return on investment (ROI) of risk-based quality management (RBQM) at both clinical trial and program levels.
  • To provide quantitative evidence supporting the business case for RBQM adoption in drug development.

Main Methods:

  • Two assessments were conducted: clinical trial level ROI analysis (monitoring cost efficiencies, phase duration reductions with 10% source data verification) and program-level ROI using expected net present value (eNPV) modeling.
  • Analyses utilized data from 18 completed oncology trials employing RBQM, alongside industry benchmarks.

Main Results:

  • RBQM implementation led to 8-19% reductions in clinical phase durations and up to 18% in monitoring costs (10% SDV scenario).
  • Clinical trial ROIs ranged from $3.2M (Phase 1) to $18.9M (Phase 3), with multiples of 6x to 23x.
  • Program-level eNPV gains ranged from $3.8M (Phase 1) to $13.8M (Phase 3), with multiples of 4x to 14x.

Conclusions:

  • Demonstrated ROI at trial and program levels provides a strong business case for RBQM adoption, aligning with ICH E6 R3 guidelines.
  • RBQM enhances data quality, risk detection, resource allocation, development efficiency, and portfolio productivity.
  • RBQM represents a strategic investment for optimizing drug development processes.