Regulatory preference for risk-based monitoring of clinical-trial sites is behind the launch of CluePoints, a new US-based software and service provider offering Intelligent Statistical Monitoring solutions.

CluePoints is an offshoot of eClinical and biostatistical services provider International Drug Development Institute (IDDI), which has spent a decade perfecting the statistical algorithms that make up CluePoints’ core SMART platform.

The founder of CluePoints, Harvard-trained biostatistician Marc Buyse, is also the founder and chairman of IDDI, as well as Associate Professor of Biostatistics at the Universiteit Hasselt in Belgium.

IDDi was set up in 1991 and has been based in Louvain-la-Neuve, Belgium since 2006. In 2001 the company established US operations in Cambridge, Massachusetts, where CluePoints now has its headquarters.

Pragmatic approach

The new operation answers a growing need in industry for a pragmatic approach to risk-based monitoring in clinical trials, CluePoints said.

The service enables trial sponsors and contract research organisations to identify signals in study datasets and make timely decisions about which sites to target for monitoring activities and Source Data Verification (SDV), it explained.

This means corrective action can be taken early and sites re-assessed periodically throughout the course of a study, ensuring the quality and integrity of the clinical data, enhancing patient safety and, ultimately, easing the risks of regulatory submission, CluePoints added.

 The launch also reflects industry guidance from the US Food and Drug Administration and a reflection paper from the European Medicines Agency encouraging trial sponsors to embrace alternatives to traditional on-site monitoring and to explore reduced SDV using a more centralised risk-based approach, it noted.

SMART engine

 The SMART engine comprises a range of inter-connected statistical tests that, once aggregated, highlight difficult-to-detect issues in trial-site results.

This differs markedly from many of the other solutions under development across the industry, which rely on Key Risk Indicators, CluePoints said.

By contrast, SMART “processes all elements of the clinical data in a comprehensive manner, with no predetermination of risk. This results in an objective view of which sites exhibit outlying or discrepant data and, hence, allow on-site monitoring activities to be targeted to address those centres as a priority”.

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”, commented CluePoints’ chief executive officer, Francois Torche.