Trust is the foundation.
ProCTTH is engineered to meet the most demanding regulatory and security standards in clinical research — without compromising usability.
Built to pass audit on day one.
Identity Blinding by Design
Subject PII never leaves the site. CRAs, CROs, and sponsors see anonymized records — enforced at the data layer.
21 CFR Part 11
Electronic signatures, audit trails, and validated workflows — fully compliant with FDA Part 11 requirements.
HIPAA & GDPR
End-to-end encryption, BAA-ready, and granular consent management for global studies.
GCP-ICH E6 (R3)
Built around Good Clinical Practice principles with risk-based monitoring support.
ISO 27001 Infrastructure
SOC-grade hosting with continuous monitoring, intrusion detection, and disaster recovery.
Role-Based Access
Profiles for Super Admin, Admin, Study Admin, and Member — combined with Subject, Investigator, CRA, and CRC roles.
Five layers of protection, by default.
Encryption
AES-256 at rest, TLS 1.3 in transit. Tenant-isolated keys with quarterly rotation.
Data residency
EU, US, India, Japan, and Canada regions. Pin a study to one region — no cross-region replication unless you request it.
Threat detection
24/7 SIEM coverage, automated anomaly detection, and incident response within contractual SLAs.
Validation pack
Pre-built CSV/V&V documentation: URS, FRS, IQ, OQ, PQ, and traceability matrices on request.