CluePoints

CluePoints, founded in 2012 and headquartered in Belgium, develops Risk-Based Quality Management (RBQM) and Data Quality Oversight software for clinical trials. Its platform applies advanced statistics and machine learning to detect risks and anomalies in trial data, and is used by sponsors, contract research organisations and pharmaceutical companies across the European Union, the United States and beyond. The company reports that its software has supported thousands of clinical studies and has more than 11,700 users worldwide.

The firm's technical work spans machine learning, artificial intelligence, statistical modelling and anomaly detection. Notably, CluePoints holds a cooperative research and development agreement (CRADA) with the FDA to assess data quality using statistical modelling and machine learning - an area of regulatory engagement that is unusual among software vendors in the field. The company also states that its methods have been recognised by regulatory bodies.

Its product suite includes the Site Profile and Oversight Tool (SPOT) for site profiling and oversight, Medical and Safety Review (MSR), an AI-powered Intelligent Medical Coding solution, and Intelligent Query Detection (IQD) for identifying data issues. The tools are aimed at clients in pharmaceuticals, clinical trials, medical devices and academic research, and are designed to help them operationalise RBQM and prepare trials for regulatory inspection.