One Platform.
AI-Powered Intelligence Across Every Trial.
CluePoints brings together the full spectrum of clinical data quality oversight: centralized RBQM, site-level monitoring, intelligent medical coding, safety review, and query detection, in one connected, AI-powered, ICH E6(R3)-aligned platform.
What Our Solutions Help You Achieve
CluePoints clients consistently report earlier detection of critical issues, stronger inspection readiness, and significant reductions in data review and monitoring burden across RBQM, safety review, medical coding, and query detection.
Detect Issues Before They Escalate
Surface meaningful data issues earlier across risk signals, data quality, coding consistency, and safety, before they escalate into regulatory findings.
Ensure Data Integrity Across Every Study
Demonstrate ICH E6(R3)-aligned oversight with full traceability, from risk identification through documented action, so your data, decisions, and submissions are consistently defensible.
Accelerate Timelines Without Adding Headcount
Reduce monitoring burden, cut manual coding and listing review effort, and free your teams to focus on higher-value clinical oversight.
Our Technology
The only AI-powered platform purpose-built to unify RBQM and clinical data review, combining advanced statistics, machine learning, and agentic AI to deliver centralized risk detection, site oversight, medical coding, safety review, and query detection in a single inspection-ready environment.
What sets CluePoints apart isn’t the category. It’s the analytical depth behind it. CluePoints applies statistical methods that threshold-based tools and AI-wrapper products cannot replicate, translating that rigor into the right data, surfaced at the right time, driving the right action.
Risk-Based Quality
Management (RBQM)
Detect risks earlier, prioritize sites objectively, and demonstrate ICH E6(R3)-aligned oversight with confidence. CluePoints RBQM combines its Central Monitoring Platform (CMP) for centralized statistical monitoring with the Site Profile and Oversight Tool (SPOT) for objective, multi-factor site risk scoring, turning signals into proportionate, traceable action.
Intelligent Medical
Coding (IMC)
Reduce manual coding effort by ~50% with deep learning trained on your validated historical decisions. Consistent, accurate MedDRA and WHODrug coding at scale, across studies, and through every dictionary upversion.
Medical & Safety
Review (MSR)
Replace manual listing review and fragmented query workflows with a structured, validated platform. MSR delivers centralized safety review dashboards, automated outlier detection, and direct two-way EDC connectivity.
Intelligent Query
Detection (IQD)
Stop investigating false positives and start confirming real discrepancies. IQD applies agentic AI to manual listing review, achieving 80%+ precision and >99% recall, and posts queries directly to Veeva EDC with a single click.
CONSULTING & SERVICES
Expert Guidance from Implementation to Ongoing Strategy
Technology enables RBQM and clinical data review. Governance sustains them. Our clinical specialists work alongside your team to design RBQM frameworks, build clinical data review workflows, configure the platform, and drive adoption across functions, so your investment delivers results from day one.
Solutions Tailored to Your Organization
Find out how CluePoints delivers RBQM and clinical data review solutions tailored to your organization’s scale and model.
Ready to See It in Action?
Book a personalized demo or explore on-demand recordings at your own pace.