What to Look for in an EDC Platform

What to look for in an EDC platform: integration, 21 CFR Part 11–aligned controls, implementation speed, and validation support. Checklist and common mistakes.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

What to Look for in an EDC Platform

When evaluating an EDC platform, look for integrated eConsent and ePRO in one platform and one audit trail, 21 CFR Part 11–aligned controls and HIPAA-aligned security, implementation speed and study builder, pricing fit for your study size, and documentation to support sponsor validation when required. This page gives you selection criteria, a checklist, common mistakes to avoid, and how Capture fits. Use it to build a shortlist or internal case for selecting software.

What to look for in an EDC platform

Key factors: integration (eConsent, ePRO in same platform and audit trail); 21 CFR Part 11–aligned controls (e-signature, audit trail, access control) and HIPAA-aligned security; implementation speed and study builder or rapid deployment; pricing and contract fit; documentation and support for sponsor validation and UAT. Avoid choosing without verifying compliance and validation support; avoid assuming all platforms offer the same integration.

Checklist: what to look for

  • Integrated eConsent, ePRO, and EDC in one platform and one audit trail
  • 21 CFR Part 11–aligned controls 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 use

Common mistakes when evaluating EDC platforms

  • Not verifying 21 CFR Part 11–aligned controls and validation support
  • Accepting separate eConsent and ePRO instead of one platform and one audit trail
  • Underestimating implementation time and change-control overhead
  • Not asking about validation documentation 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)
  • Rapid build and deployment; book a demo to evaluate fit

Related

Clinical trial software selection guideHow to choose an EDC systemFeatures

FAQ

Questions we hear a lot

What should I look for in an EDC platform?
Look for integrated eConsent and ePRO, 21 CFR Part 11–aligned controls, implementation speed, pricing fit, and documentation for sponsor validation. Use a checklist and book demos to compare platforms.
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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