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.
SOC-grade hosting with continuous monitoring, intrusion detection, and disaster recovery.
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.
