Press Release

CluePoints’ Audit Trail Review Project Wins Award for Innovation in the Management of Clinical Data Award

King of Prussia, PA – March 5, 2024: CluePoints, providers of best-in-class statistical and AI-driven software solutions, has won the 2024 Annual Association of Clinical Data Management (ACDM24) Innovation in the Management of Clinical Data Award. The Award recognized a collaborative project, led by Sebastiaan Hoppner, Sr. Research Scientist in Statistics, with CluePoints’ Statistical Research and Development Team, which delivered a new and improved methodology for clinical research organizations to proactively identify and address data quality risk.

For this project, working with data provided by its clinical research partners, the CluePoints’ team developed new and improved methods to detect anomalies, using ePRO audit trail data to detect risks in data quality. They first built a use case library of historic audit trail data that contained known issues; the team then developed a novel statistical test to detect risk signals in the audit trail timestamp data which records the time of data entry. This new test analyzes data entry timestamps, such as those associated with electronic patient-reported outcomes (ePRO) data, and assesses how closely correlated the daily entry times are between patients at a particular site compared to other sites in the study, to identify scenarios in which a site’s patients are submitting their diaries in unusually close proximity to each other. This is important as deviations from the expected pattern may signal potential issues, such as data fabrication or bias by the site and/or study protocol non-compliance by patients.

Innovative best practice was further evidenced through the knowledge sharing of findings with a wider community of clinical research companies, via CluePoints’ Central Monitoring Platform. The company’s ongoing commitment to industry-wide advancement continues through the development of guidelines on applying risk-based approaches in general to drive Audit Trail Review, including developing a minimal set of standardized supervised review metrics, for use by the wider community.

Commenting on the accolade, Steve Young, Chief Scientific Officer of CluePoints, said: “By developing and testing new, automated methods for detecting prioritized risk scenarios in audit trail data, CluePoints have demonstrated the increasing value of examining audit trail data using state-of-the-art methods to ultimately increase risk management efficiency in clinical trials. This accolade is valued recognition for the work of CluePoints’ specialist teams that continually strive to address systemic issues in data quality or trial execution that have the potential to impact overall trial integrity. With all risk signals investigated and any necessary corrective action taken before they have a chance to impact overall trial integrity, CluePoints’ new methodology can better protect participant safety and trial integrity compared to traditional source data verification methods, and improve inspection readiness, thereby streamlining drug development processes.”

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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.

About ACDM24:

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Jodie Dixon – Discovery PR, on behalf of CluePoints
Email:   [email protected]
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