Game-Changing ‘Audit Trail Review’ Application Secures ACDM 2024 Awards Nomination for CluePoints

Game-Changing ‘Audit Trail Review’ Application Secures ACDM 2024 Awards Nomination for CluePoints

RBQM Leader Shortlisted for Accolade for Innovation in the Management of Clinical Data

King of Prussia, PA– February 6^th, 2024: CluePoints, providers of best-in-class statistical and AI-driven software solutions, has been shortlisted for the 2024 Annual Association of Clinical Data Management (ACDM24) Awards, in the category of Innovation in the Management of Clinical Data. The 2024 Winners will be announced at ACDM24 on March 4th in Copenhagen, Denmark.

CluePoints’ Statistical Research and Development Team, led by Sebastiaan Hoppner, Sr. Research Scientist in Statistics, has been recognized for a collaborative project that used ePRO audit trail data to detect risks in data quality. Working with data provided by its pharmaceutical partners, the team developed new and improved methods to detect anomalies in audit trail data, then shared this with a wider community of biopharmaceutical companies through its Central Monitoring Platform.

Through sharing knowledge of these findings with the wider community at conference presentations and in peer-reviewed publications, the CluePoints team are further contributing to industry-wide advancement. They are also in the process of creating 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 biopharma community.

Steve Young, Chief Scientific Officer of CluePoints, commented, “In an era where clinical trials are expanding in scope and complexity, the introduction of Audit Trail Review - as a cornerstone of RBQM strategy - signifies a significant step towards ensuring the highest standards of data quality, integrity, and risk management in clinical trials, and is aligned with recent updates to regulatory expectations. This nomination represents valued recognition from our clinical data management peers and provides an opportunity through the ACDM Awards for sharing best practice to improve process and increase positive outcomes in clinical research.”

For further information on CluePoints’ solutions, please visit www.cluepoints.com

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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: https://acdmglobal.org/acdm-awards-2024/