Statistical engine enhances ePRO data integrity and compliance through advanced AI-driven timestamp analysis

CluePoints has been named a finalist in the 2025 Citeline Awards for its Time Similarity Test (TST)—a new statistical feature designed to improve data quality and trial oversight by detecting irregularities in electronic patient-reported outcomes (ePRO).

Shortlisted in the ‘Innovative Clinical Trial Solutions’ category, the recognition reflects CluePoints’ continued leadership in Risk-Based Quality Management (RBQM) and AI-powered analytics. The TST, launched as part of CMP 3.0, leverages audit trail timestamps to flag instances where patient data is entered at suspiciously similar times—potentially indicating site non-compliance or even data fabrication.

By surfacing anomalies early, TST helps sponsors and CROs act swiftly to ensure data integrity, minimize regulatory risks, and avoid delays in trial timelines and submission preparation.

“Our new TST technology provides sponsors and CROs with the ability to interrogate ePRO audit trails to quickly identify concerning data entry patterns,” said Andy Cooper, CEO of CluePoints.

“This innovation allows teams to run smarter clinical trials and bring new therapies to market faster, ultimately benefiting patients.”

CluePoints has a strong track record in clinical trial enablement, offering sponsors and regulators validated, statistical approaches to improve risk detection, compliance, and operational efficiency. The nomination places the company among a select group of leaders being recognized for shaping the future of trial management through meaningful technological innovation.

The 2025 Citeline Awards ceremony takes place on May 8 at the Hyatt Regency Boston, spotlighting excellence in clinical development, patient engagement, and operational strategy.