Turning Artificial Intelligence into Human Intelligence
Detect risk earlier. Ensure data quality. Run better trials. CluePoints is the leading RBQM and clinical data review platform for Sponsors and CROs, combining centralized risk detection, site-level action, intelligent medical coding, safety review, and query detection in a single, regulatory-grade, ICH E6(R3)-aligned platform.
18,900+
Platform Users
2,800+
Studies De-Risked
320,000+
Potential Issues Detected
Built for How You Work
Explore how CluePoints delivers RBQM and clinical data review solutions tailored to your organization’s scale and model.
Enterprise-Scale RBQM for Large Pharmaceutical Companies
Managing a global pipeline across multiple CRO partners, EDC systems, CTMS platforms, and safety databases demands oversight that scales. CluePoints provides large pharma with a unified RBQM and clinical data review platform, delivering portfolio-wide risk visibility, consistent quality governance, smarter medical coding, streamlined safety review, and an inspection-ready evidence trail that regulators expect under ICH E6(R3).
Regulatory-Grade RBQM Without the Enterprise Overhead
Mid-market Sponsors carry the same ICH E6(R3) obligations as the largest pharma companies, but with leaner internal teams and greater reliance on CROs. CluePoints provides an independent, Sponsor-side oversight platform for RBQM and clinical data review, giving Sponsors their own view of quality, risk, and data integrity across partners, without the overhead of building an internal clinical data oversight function from scratch.
The RBQM Execution Platform for CROs That Compete on Quality
Sponsors are no longer evaluating CROs solely on monitoring volume. They want to understand why risks were prioritized, how oversight was applied, and whether decisions are defensible. CROs that can demonstrate a standardized, scalable operating model win more studies, protect margins, and strengthen Sponsor retention. CluePoints is the operational backbone for RBQM and clinical data review, enabling a repeatable, inspection-defensible model across every study.
Explore Our AI-Powered Solutions
From centralized risk detection and site-level action to intelligent coding, safety review, and query detection. One platform, fully connected.
Risk-Based Quality
Management (RBQM)
End-to-end risk detection, site prioritization, and inspection-ready documentation in one platform. CluePoints RBQM combines centralized statistical monitoring with objective, multi-factor site risk scoring to turn risk signals into proportionate, traceable action.
Intelligent Medical
Coding (IMC)
Cut manual coding effort by ~50% with deep learning that applies decisions consistently at scale.
Medical & Safety
Review (MSR)
Transform mandatory periodic safety review from fragmented manual work into a structured, audit-ready workflow.
Intelligent Query
Detection (IQD)
Identify true data discrepancies with 80%+ precision, so your team can confirm findings rather than chase false positives.
CONSULTING & SERVICES
Expert Guidance from Implementation to Ongoing Strategy
CluePoints’ clinical specialists bring decades of hands-on experience across RBQM implementation, clinical data review, and data quality oversight, spanning CtQ framework design and KRI/QTL development to medical coding governance, safety review workflows, and inspection-readiness support.
Navigate ICH E6(R3) with Confidence
ICH E6(R3) cements RBQM as a core GCP requirement and raises the bar for what regulatory-grade oversight means in practice. For Sponsors and CROs, that means documented, proportionate, end-to-end oversight from protocol design through final study report. The CluePoints RBQM Guide breaks down exactly what ICH E6(R3) requires and how CluePoints operationalizes every element — from protocol design through final study report.
Dive into CluePoints’ Resource Hub
Research, guides, webinars, and events—everything you need to lead with RBQM.
Event: Register for RBQMLive 2026
The Ultimate Guide to Modern RBQM
Upcoming Events & Webinars
Join the CluePoints Team
Help us build the technology that makes clinical trials safer, smarter, and faster.
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