Security & Compliance

Built for regulators, not retrofitted for them.

Trelice handles the documents that define how patients are treated. We build the platform to the standard the regulator expects, because anything less isn’t real.

Regulatory standards

21 CFR
Part 11
E-signatures, audit trails, access control.
ICH
M11
Harmonized protocol template & terminology.
CPT
TransCelerate
Common protocol template v8.
CDISC
Aligned
Standard vocabulary & data structures.

Infrastructure

SOC 2
Type II (in progress)
Report available on request under NDA. Placeholder.
ISO
27001 (planned)
Target: 2026. Policies documented today.
HIPAA
BAA-ready
Business Associate Agreements available for US sites.
GDPR
Compliant
EU data residency optional on Enterprise.
Practices

Security practices

Encryption

AES-256 at rest, TLS 1.3 in transit. Customer data encrypted with per-tenant keys.

Access control

SSO via SAML / OIDC. Role-based access at document and field level. Session binding.

Audit trail

Every read, write, and approval event logged, immutable, and exportable. Architected to support 21 CFR Part 11 requirements; validation in progress.

Backup & continuity

Point-in-time recovery to any second in the last 35 days. Multi-region standby on Enterprise.

Vulnerability management

Annual pen test by an independent third party. Continuous dependency scanning. 48-hour critical patch SLO.

Data residency

US or EU at standard tier. APAC on Enterprise. No cross-region replication without written consent.

Disclosure

Responsible disclosure

Found a vulnerability? Email security@trelice.com. We aim to acknowledge within one business day and resolve critical issues within 7 days. We run a private bug-bounty programme; contact us for scope.