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CluePoints

CluePoints provides RBQM and data quality oversight software using AI, machine learning and statistical modelling to detect risks and anomalies in clinical trial data for sponsors and CROs.

CluePoints builds software that applies advanced statistics, artificial intelligence and machine learning to clinical trial data. Founded in 2012 and headquartered in Belgium, the company sells Risk-Based Quality Management (RBQM) and Data Quality Oversight tools that sponsors, contract research organisations and pharmaceutical firms use to spot risks and anomalies in trial data, both during and after study conduct. Its technical work spans statistical modelling, anomaly and risk detection, and machine learning applied to clinical data quality analysis.

The product suite includes the Site Profile and Oversight Tool (SPOT) for site profiling and oversight, Medical and Safety Review (MSR), an AI-driven Intelligent Medical Coding solution, and Intelligent Query Detection (IQD) for flagging data queries. The platform is used by more than 11,700 people worldwide and has supported thousands of clinical studies. CluePoints also holds a Cooperative Research and Development Agreement (CRADA) with the FDA to assess data quality using statistical modelling and machine learning.

Customers come from pharmaceuticals, medical devices, academic research and the CRO sector. The company operates from Belgium with a presence across the European Union and the United States, and a user base distributed worldwide.

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