TrialScale

Architecture brief

Evaluate the validation approach before you request a meeting.

Explore the architecture brief’s scope and review the document directly. The material describes design intent and qualification considerations; it is not a certificate of compliance for a particular deployment.

Inside the architecture brief

  • Risk-based software assurance and qualification responsibilities
  • Electronic records, signatures, and auditability considerations
  • Security architecture and operational control boundaries
Read the architecture brief (PDF, no form required)

Request an architecture walkthrough

Have a specific validation question? Send your details to request a discussion about controls and qualification scope.

Essential cookies are required; site analytics are optional.

TrialScale Cookie & Telemetry Policy

As a clinical operations technology platform designed for 21 CFR Part 11 and EU Annex 11 alignment, TrialScale maintains strict data integrity and privacy boundaries. We categorize browser storage into two distinct classes:

1. Strictly Necessary Storage (Always Active)Required

Essential for core website operation, CSRF/bot mitigation (Cloudflare Turnstile token validation), and theme persistence. These tokens do not track users across domains and cannot be turned off.

2. Google Analytics (GA4) TelemetryOptional

Measures aggregate interaction metrics (session length, page scroll depth, device viewport) without collecting HIPAA PHI or clinical study subject data. IP anonymization is enforced by default.