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RBQM Market Leader, CluePoints, Celebrates Milestone of De-risking 1000 Clinical Studies

RBQM Market Leader, CluePoints, Celebrates Milestone of De-risking 1000 Clinical Studies


Risk-Based Quality Management: 10 Years of enhancing Quality, Accuracy, and Integrity across all Clinical Trial Data

King of Prussia, PA – 6 February 2023: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has announced a significant milestone today: they have de-risked over 1000 clinical studies. 

With over 6,000 platform users and more than 100,000 issues detected, CluePoints is proud to have been an integral player in the adoption of Risk-Based Monitoring (RBM) and later RBQM since the US Food and Drug Administration (FDA) first recommended its use in 2013. Having recently celebrated its tenth anniversary, the company has grown from strength to strength. More recently, its 200-strong team was pivotal in providing Risk-Based Quality Management (RBQM) software to support a number of COVID-19 vaccine and mRNA trials, including the first COVID-19 vaccine to receive regulatory approval within 266 days of the pandemic declaration.

Patrick Hughes, Chief Commercial Officer and Co-Founder at CluePoints stated: “This milestone demonstrates the industry’s ever-growing adoption of data-driven RBQM, reinforcing that this approach is the future of clinical trial oversight and management. With each advancement of the ICH regulations, there has been a growing insistence on the requirement for Sponsors and CROs to adopt risk-based approaches over traditional inefficient techniques, such as Source Data Verification (SDV) and other manual processes.”

CluePoints’ RBQM platform is used to detect and mitigate potential risks as early as possible, allowing corrective action to be taken at record speed. Teams can access information centrally, collaborate, and document mitigations and remedial actions to ultimately produce a clean dataset of the highest quality and integrity faster than ever before.


For further information on CluePoints and its innovative RBQM solutions, please visit


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 


Mobile:   +44 (0)7507 727721

Office:   +44 (0) 1606 889 194

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Last Updated: 07-Feb-2023