CluePoints® is a provider of Central Statistical Monitoring solutions that have been designed and perfected over the last 10 years. It employs unique 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 and EMA, CluePoints is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a risk-based monitoring strategy.
The value of using CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
CluePoints addresses the increasing industry need for a pragmatic approach to the challenge posed by regulators, allowing the risk-based monitoring theory to become a reality. Our Central Statistical Monitoring software identifies signals in a clinical trial data set, including erroneous and discrepant data, allowing sponsors and CROs to improve the quality and integrity of their clinical data, reduce regulatory submission risk and drive down operational costs.
CluePoints allows biopharmaceutical sponsors and CROs to make timely decisions about which sites to target for monitoring activities and Source Data Verification (SDV). As a result, corrective action can be taken early and sites reassessed periodically throughout the course of a study to ensure the quality and integrity of the data, enhance patient safety and, ultimately, reduce regulatory submission risk.
CluePoints’ in response to recent industry guidance from the FDA and a reflection paper from the EMA encouraging sponsors to embrace an alternative to traditional on-site monitoring techniques and to explore reduced or targeted Source Data Verification (SDV) using a risk-based approach to monitoring.
At the heart of the CluePoints solution is the SMART™ engine, comprising a comprehensive range of inter-connected statistical tests that make no distributional assumptions about the clinical data but, when aggregated together, highlight difficult to detect issues in the site results. The brainchild of Harvard-trained biostatistician Marc Buyse, CluePoints founder has evolved from academic research to a full commercial entity over the course of the last ten years.
Buyse is cited in the FDA’s Risk Based Monitoring Guidance for his work in detecting fraud in clinical trials using statistical modeling techniques (The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials. Statistics in Medicine 18, 1999). It has taken the International Drug Development Institute (IDDI) a decade to perfect the statistical algorithms that comprise the SMART engine underpinning CluePoints.
This research is endorsed by a consortium comprising GlaxoSmithKline Vaccines, the Institute of Statistics at Université Catholique de Louvain, and the Artificial Intelligence Research Laboratory of Université Libre de Bruxelles. Francois Torche, CEO of CluePoints, comments:
"It has taken a considerable amount of time to build the CluePoints solution due to the complex array of statistical algorithms used but the result is a powerful engine that can be used in all late-stage clinical trials. Not only does CluePoints help improve data quality and integrity, it also has the potential to act as the engine to drive millions of dollars in cost savings via reduced monitoring and SDV."
The powerful and sophisticated process used to detect anomalies in site data is currently pending patent protection with the United States Patent and Trademark Office.
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