EDC Procurement Checklist
EDC procurement checklist: selection criteria for buying EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. Download checklist.
21 CFR Part 11 compliant · HIPAA-compliant security · No credit card required
Overview
EDC Procurement Checklist
An EDC procurement checklist helps you evaluate vendors against selection criteria: integrated eConsent and ePRO, 21 CFR Part 11–compliant controls, implementation speed, pricing fit, and documentation for sponsor validation. This page gives you a quick summary, criteria, a checklist, common mistakes, and how Capture fits. Use it to build a shortlist or internal case for selecting software.
What to include in your EDC procurement checklist
Include: integration (eConsent, ePRO in one platform and one audit trail); 21 CFR Part 11–compliant controls and HIPAA-compliant security; implementation speed and study builder; pricing and contract fit; documentation and support for sponsor validation and UAT; and export for analysis and regulatory use. Avoid skipping compliance and validation support when building your checklist.
Checklist items for EDC procurement
- Integrated eConsent, ePRO, and EDC in one platform and one audit trail
- 21 CFR Part 11–compliant controls (e-signature, audit trail, access control) and HIPAA-compliant security
- Implementation speed and time to first patient; study builder or rapid deployment
- Pricing and contract fit for your study size and timeline
- Documentation and support for sponsor validation and UAT (for regulated studies)
- Export for analysis and regulatory submissions
Common mistakes in EDC procurement
- Procuring on price alone without verifying 21 CFR Part 11–compliant controls and validation support
- Not requiring integrated eConsent and ePRO in the same platform
- Underestimating implementation and change-control effort
- Not clarifying validation documentation and UAT support for regulated studies
Where Capture fits
- Single platform for EDC, eConsent, ePRO, and safety; one audit trail
- 21 CFR Part 11–compliant controls and HIPAA-compliant security; documentation for validation (Enterprise)
- Download our checklist or book a demo to evaluate fit
FAQ
Questions we hear a lot
What should be on an EDC procurement checklist?
Is Capture 21 CFR Part 11–compliant?
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