Validation built for clinical operations and CROs — EDC, CTMS, eTMF, IRT/RTSM and ePRO — under 21 CFR Part 11 and GCP, so your sponsor audits and inspections hold up.
Clinical systems we validate
We validate the platforms your studies run on, with sponsor- and inspector-ready evidence.
EDC
Electronic data capture — build, configuration and edit-check validation, with audit-trail and Part 11 controls.
CTMS
Clinical trial management — study, site and milestone tracking validated for data integrity.
eTMF
Electronic trial master file — completeness, access control and inspection-readiness.
IRT / RTSM
Randomization and trial supply management — the high-risk logic that needs the most assurance.
ePRO / eCOA
Patient-reported outcomes — device, data-flow and Part 11 validation.
Integrations
Validated data flows between clinical systems and downstream analytics.
What you receive
- Validation plan aligned to GCP & Part 11
- User requirements & configuration specs
- Risk assessment focused on subject safety & data integrity
- Edit-check and randomization test evidence
- Audit-trail and e-signature verification
- Vendor/SaaS qualification leverage
- Traceability matrix (requirements → tests)
- Audit-ready validation summary report
Built for sponsor audits. Evidence structured the way clinical QA and inspectors expect to see it — traceable, risk-based and defensible.
From protocol to validated, inspection-ready systems
Scope
Map systems, integrations and study risk.
Assess
Gap-assess configuration against GCP & Part 11.
Validate
Risk-based testing of high-impact functions first.
Sustain
Change control across amendments and releases.
Why teams choose us
Clinical-specific, not generic CSV
We know EDC edit checks and RTSM logic — not just generic validation templates.
Sponsor & CRO ready
Evidence that satisfies sponsor oversight and CRO quality alike.
Current with 2026 guidance
Part 11, Annex 11 draft and the FDA CSA final guidance (Feb 2026).
Senior practitioners
Named consultants who can defend the work in an audit.
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteValidate the systems your studies depend on
Tell us which clinical platforms are in scope. We’ll come back with a fixed-fee plan and timeline.
Request a Quote






