Press Release

Scope of Industry Risk-Based Quality Management (RBQM) Adoption Revealed

King of Prussia, PA: A comprehensive assessment of risk-based quality management (RBQM) adoption has revealed that slightly more than half of sponsors and contract research organizations (CROs) have adopted RBQM approaches.

The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted an online survey of bio-pharmaceutical and contract research organizations in collaboration with CluePoints and PwC. A manuscript with detailed results from this study has been published in the March 2024 issue of Therapeutic Innovation and Regulatory Science. After final review the findings included:

  • Overall, 57% of sponsors and CROs have adopted RBQM. The highest levels of adoption were found among sponsor bio-pharmaceutical companies, particularly those conducting high volumes of trials (100 trials plus annually). Higher levels of RBQM adoption were also observed in Europe.
  • Implementation of RBQM components was lowest at companies conducting fewer than 25 trials annually (48%)​.
  • The survey also revealed different levels of adoption at different stages of trial design and implementation. Adoption of RBQM components was lowest during execution (52%) and slightly higher during planning and documentation/resolution stages (56% and 60% respectively).
  • Lack of awareness and knowledge about RBQM was the top reported implementation challenge overall, across all stages and subgroups. Lack of skills and technology were rated as top challenges by a higher proportion of CROs compared to other types of organizations. Companies conducting fewer than 100 trials annually were more likely to report lack of technology as a top challenge during clinical trial execution.

​Looking ahead, the use of artificial intelligence (AI) alongside RBQM is expected to increase substantially by 2027.

Steve Young, Chief Scientific Officer of CluePoints, commented, “The value of RBQM-approaches has been recognized at a regulatory level for more than a decade and re-inforced with the pending publication of ICH E6 (R3). Yet this research reveals we still have remaining work to promote cross-industry and cross-functional awareness and adoption. Education will be key to ensuring that  RBQM principles become fully embraced across organizations and become “business as usual” for the industry.”

Ken Getz, Professor and Executive Director, Tufts Center for the Study of Drug Development, commented: “Although earlier studies observed increased use of select RBQM components during the pandemic, our recent study suggests that this increase was only temporary. Our results also highlight resistance to adoption associated with mixed perceptions of RBQM’s value proposition and the need for more effective change management practices to drive routine use of RBQM approaches enterprise-wide.”

Read the full research findings here.

CluePoints and Tufts CSDD are hosting a webinar where they will share and discuss the survey findings in more detail on Tuesday, April 9. To register click here:

About CluePoints:

CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. Our products utilize comprehensive statistical algorithms 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 (R2), 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 increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.


Media Contact

Jodie Dixon – Discovery PR, on behalf of CluePoints
Email:   [email protected]
Mobile:   +44 (0)7507 727721
Office:   +44 (0) 1606 889 194

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