EDC Procurement Checklist

EDC procurement checklist: selection criteria for buying EDC with eConsent, ePRO, and 21 CFR Part 11–aligned controls. Download checklist.

21 CFR Part 11–aligned · HIPAA-aligned 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–aligned 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–aligned controls and HIPAA-aligned 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–aligned controls (e-signature, audit trail, access control) and HIPAA-aligned 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–aligned 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–aligned controls and HIPAA-aligned security; documentation for validation (Enterprise)
Download our checklist or book a demo to evaluate fit

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FAQ

Questions we hear a lot

What should be on an EDC procurement checklist?

Include integration (eConsent, ePRO), 21 CFR Part 11–aligned controls, implementation speed, pricing fit, and validation support. Use the checklist to compare vendors and build a shortlist.

Is Capture 21 CFR Part 11–aligned?

Yes. Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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