CluePoints RBQM and AI Clinical Data Review Platform

CluePoints is a provider of risk-based quality management (RBQM) and data quality oversight software for clinical trials, operating through CluePoints S.A., CluePoints UK, CluePoints Inc and CluePoints PL, with the Belgian data protection authority as lead regulator and a US base in Wayne, Pennsylvania. It helps sponsors and CROs find data errors, site risks and safety signals that manual source verification misses.

The platform uses statistics, machine learning and AI. Its Central Monitoring Platform applies multi-factor site risk scoring, KRIs and QTLs, while the Site Profile & Oversight Tool supports site oversight. Newer AI applications include Intelligent Query Detection for targeted, evidence-backed queries, Medical & Safety Review for continuous patient-level review, and Intelligent Medical Coding, which suggests MedDRA and WHODrug codes within Veeva Vault EDC. The company reports 18,900+ users and 2,800+ studies de-risked.

• Central Monitoring Platform: statistical monitoring with multi-factor site risk scores.
• KRIs and QTLs: configurable key risk indicators and quality tolerance limits.
• Site Profile & Oversight Tool: consolidated view of site performance and risk.
• Intelligent Query Detection: no-code scenarios that return only records needing queries.
• Medical & Safety Review: continuous patient-centred review with queries posted back to EDC.
• Intelligent Medical Coding: deep-learning MedDRA and WHODrug suggestions within Veeva Vault EDC.

CROs in Vietnam can offer centralised monitoring and RBQM services to sponsors in line with ICH E6(R3). Pharmaceutical sponsors running regional trials can detect underperforming sites earlier and cut on-site monitoring visits. Data management teams can speed up medical coding and safety review.

A Tufts CSDD peer-reviewed analysis of 18 oncology trials on the platform reported 8-19% shorter clinical phases and 6x to 23x ROI at trial level. Intelligent Medical Coding is cited at up to 99% MedDRA accuracy and about 50% less manual coding. Intelligent Query Detection is cited at 80%+ precision, reducing broad manual listing reviews. Medical & Safety Review deploys in days and is system-agnostic.

The ICH E6(R3) guideline makes risk-based quality management central to good clinical practice, pushing sponsors and CROs toward centralised statistical monitoring. As Southeast Asia, including Vietnam, hosts more multinational trials, local CROs and sites face higher expectations for data quality oversight and audit-ready review.

Entities include CluePoints S.A., CluePoints UK Ltd, CluePoints Inc and CluePoints PL, with US and EU offices. Partnered with Japan's EPS Corporation (2020). Published a peer-reviewed RBQM value study with Tufts CSDD in 2026; hosts the annual RBQMLive event.