CRO and clinical systems validation
Preparing for a sponsor audit or an inspection of your clinical systems? Validate the systems your studies depend on, from protocol to inspection-ready. Evidence is traceable, risk-based and built for sponsor audits.
The challenges this solves
Randomization logic worries us
IRT and RTSM errors affect subject safety and study integrity.
Sponsors audit our systems
We need evidence that is traceable and defensible.
Amendments keep changing the build
Each protocol amendment and release needs change control.
What we deliver
- EDC build, configuration and edit-check validation, with audit-trail and Part 11 controls
- CTMS study, site and milestone tracking validated for data integrity
- eTMF completeness, access control and inspection readiness
- IRT and RTSM randomization and trial supply logic
- ePRO and eCOA device, data-flow and Part 11 validation
- Validated data flows between clinical systems and downstream analytics
- Vendor and SaaS qualification leverage
Systems and tools
- Medidata Rave
- Oracle InForm
- Oracle CTMS
- Veeva Vault Clinical
- Veeva Vault eTMF
- ClinCard
4 steps, clear deliverables
- 01
Scope
Map systems, integrations and study risk.
You receive: Validation plan aligned to GCP and Part 11
- 02
Assess
Gap-assess the configuration against GCP and Part 11.
You receive: Risk assessment focused on subject safety and data integrity
- 03
Validate
Test high-impact functions first.
You receive: Edit-check and randomization evidence and traceability matrix
- 04
Sustain
Apply change control across amendments and releases.
You receive: Audit-ready validation summary report
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- CROs & clinical
- Pharma & biopharma
- Biotech
- Medical devices
Related services
Questions we hear most
Which clinical systems do you validate?
EDC, CTMS, eTMF, IRT/RTSM and ePRO/eCOA systems, plus their integrations. Named systems include Medidata Rave, Oracle InForm and Veeva Vault eTMF.
Is this different from general CSV?
Yes. It is clinical-specific, covering EDC edit checks and RTSM logic against GCP and Part 11.
Do you work for sponsors or CROs?
Both. The evidence is built for sponsor audits.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Validate the systems your studies depend on
Get a scoped, fixed-fee quote for your clinical systems.