Compliance and validation
TrialTrack is built for regulated environments. It is aligned with ICH E6(R3), 21 CFR Part 11, 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
Held by Mayet, company-wide
Built for GxP compliance
The technical controls ICH E6(R3) Section 4.3.4 expects of a computerised system used in regulated research.
Complete audit trail
Immutable, timestamped records of all user actions. Exportable for inspections and regulatory submissions.
Automated testing on every release
Every release passes 410+ automated test cases covering business logic, permissions and audit trail generation.
Role-based access
Admin, Editor and Viewer roles with study-level scoping. MFA available on all plans, SSO on Enterprise.
Validation documentation
Validation and security documentation you can hand to your QA team, plus plain-language release notes for every version.
ALCOA++ data integrity
How TrialTrack supports each ALCOA++ principle of data integrity.
Attributable
User attribution for all actions
Legible
Clear, readable data exports
Contemporaneous
Automatic timestamping
Original
Immutable audit records
Accurate
Date and form field validation on entry
Complete
Deletions recorded in the audit trail
Consistent
Every record entered through the same structured forms
Enduring
Continuous backups
Available
Audit trail exportable as a PDF at any time
Traceable
Every change linked to who, when and the previous value
Security
Mayet is Cyber Essentials Plus certified. TrialTrack runs on Fly.io, encrypted at rest and in transit.
Infrastructure
Data protection
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