Compliance & Validation
TrialTrack is built for regulated environments. Supports ICH E6(R3) and 21 CFR Part 11 requirements, aligned with EU Annex 11 and ALCOA++ principles.
ICH E6(R3) Aligned
Good Clinical Practice
Part 11 & Annex 11
Electronic Records
ALCOA++ Aligned
Data Integrity
Cyber Essentials Plus
Company Cybersecurity
Built for GxP Compliance
TrialTrack provides technical controls aligned with ICH E6(R3) Section 4.3.4, 21 CFR Part 11, and EU Annex 11 requirements for computerized systems in regulated research.
Continuous Validation
Every release is validated against 410+ automated test cases covering business logic, permissions, and audit trail generation.
Complete Audit Trail
Immutable, timestamped records of all user actions. Exportable for inspections and regulatory submissions.
Role-Based Access
Admin, Editor, and Viewer roles with study-level scoping. MFA available on all plans, SSO on Enterprise.
Validation Documentation
Full documentation on our validation and security processes. Changelog with details for every release.
ALCOA++ Data Integrity
Our platform is designed to support every principle of data integrity required in regulated research.
Attributable
User attribution for all actions
Legible
Clear, readable data exports
Contemporaneous
Automatic timestamping
Original
Immutable audit records
Accurate
Validated data handling
Complete
Nothing deleted or lost
Consistent
Standardized formats
Enduring
Continuous backups
Enterprise-Grade Security
Cyber Essentials Plus certified with robust infrastructure controls.