ProCTTH is engineered to meet the most demanding regulatory and security standards in clinical research without compromising usability.
Subject PII never leaves the site. CRAs, CROs, and sponsors see anonymized records enforced at the data layer.
Electronic signatures, audit trails, and validated workflows fully compliant with FDA Part 11 requirements.
End-to-end encryption, BAA-ready, and granular consent management for global studies.
Built around Good Clinical Practice principles with risk-based monitoring support.
Profiles for Super Admin, Admin, Study Admin, and Member combined with Subject, Investigator, CRA, and CRC roles.
AES-256 at rest, TLS 1.3 in transit. Tenant-isolated keys with quarterly rotation.
EU, US, India, Japan, and Canada regions. Pin a study to one region. No cross-region replication unless you request it.
24/7 SIEM coverage, automated anomaly detection, and incident response within contractual SLAs.
Pre-built CSV/V&V documentation: URS, FRS, IQ, OQ, PQ, and traceability matrices on request.
