CluePoints

CluePoints combines clinical trial oversight software with consulting and services for sponsors and CROs. Its portfolio covers risk-based monitoring, data quality analysis, intelligent coding, clinical data review, and inspection preparation.

Risk-Based Trial Oversight

• Study teams prioritize site oversight with CMP and SPOT, using statistical risk signals, site scores, targeted SDV/SDR, and adaptive visit planning.
• Clinical operations teams document monitoring decisions through governed workflows covering signal detection, investigation, action, and resolution.

Clinical Data and Quality Control

• Data managers review cross-domain discrepancies with IQD, which provides evidence-backed findings and editable query submission to Veeva EDC.
• Quality teams analyze audit trails and clinical data for manipulation, anomalous entry behavior, duplicate patients, and other data-integrity risks.

Analytics, Coding, and Readiness

• Coding teams receive ranked MedDRA and WHODrug suggestions from IMC while retaining approval, validation, and regulatory dictionary control.
• Quality and clinical leaders receive consulting for RBQM design, inspection preparation, oversight documentation, and training.

Best Fit

• Sponsors and CROs needing centralized, risk-based oversight across clinical and operational data can use CMP, SPOT, and related review workflows.
• Clinical operations, data management, coding, safety, and quality teams can engage CluePoints for process training and inspection readiness.