Press Release · July 23, 2026

Pi Health Adds Continuous Data Integrity Monitoring to the FICS Clinical Trial Operating System

CDIM brings embedded, always-on AI to the complete trial record, extending RBQM beyond centralized statistical monitoring and surfacing the GCP data-integrity issues and protocol deviations that field-level edit checks and sampled SDV routinely pass over.

Boston, Mass. Pi Health today introduced CDIM (Continuous Data Integrity Monitoring), a new capability within its FICS clinical trial operating system. CDIM continuously reviews the complete trial record and surfaces data-integrity issues and protocol deviations affecting data quality and go/no-go decisions, delivering verified, plain-language findings to data management, clinical monitoring, and quality assurance teams.

Since ICH E6(R3) took effect, sponsors and CROs have moved toward RBQM, with centralized monitoring replacing wholesale on-site SDV. Centralized statistical monitoring flags aggregate outliers, but protocol deviations visible only in event sequences and integrity issues clearing field-level edit checks remain undetected. CDIM addresses this gap.

CDIM reads the full FICS record where EDC, CTMS, eTMF, eISF, and IRT share a single audit trail, interpreting it contextually. It weighs potential issues against underlying records, surfacing substantiated findings as plain-language reports prioritized by impact on data quality, with supporting records attached.

The system investigates both curated integrity checks and novel issues. It identifies protocol deviations in recorded sequences, records changed after sign-off, unexpected access and activity, and cross-system analytical discrepancies.

Data managers can explore findings, examine underlying records, ask follow-up questions, and resolve issues within FICS workflow without exporting data. Recommended next steps accompany each finding.

Continuous review extends RBQM beyond centralized statistical monitoring, directing SDV toward records warranting closer examination. CDIM supports GCP data-integrity expectations, ALCOA+ principles, and 21 CFR Part 11 audit-trail controls.

Early issue surfacing maintains record cleanliness throughout the trial, supporting faster database lock. CDIM operates on the same record used for trial capture, keeping quality oversight and data capture aligned.

CDIM is available today as part of the FICS platform.

About Pi Health

Pi Health is a Boston-based oncology clinical trial and technology company founded in 2021. Its platform, FICS, is an AI-native operating system for clinical trials unifying EDC, CTMS, eTMF, eISF, and IRT on a single shared record, providing one source of truth across the trial lifecycle without cross-system reconciliation.

Media contact

Gracie Hong, Pi Health
gracie.hong@pihealth.ai