EDC for CRO-Independent Trials

EDC for CRO-independent trials: selection criteria and fit when not using a full-service CRO. EDC with eConsent, ePRO, and 21 CFR Part 11–aligned controls.

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

Overview

EDC for CRO-Independent Trials

EDC for CRO-independent trials must support sponsor- or site-led build and operation without depending on a full-service CRO: one platform for EDC, eConsent, and ePRO with 21 CFR Part 11–aligned controls and documentation for sponsor validation. This guide gives you selection criteria, a checklist, common mistakes, and how Capture fits. Use it to build a shortlist or internal case for selecting software.

Selection criteria for CRO-independent trials

CRO-independent trials need: one platform that sponsor or site can build and run; 21 CFR Part 11–aligned controls and HIPAA-aligned security; study builder or rapid deployment without CRO-led setup; documentation to support sponsor validation; and pricing and contract fit for studies run without a full-service CRO. Avoid assuming CRO-led implementation is required; many platforms support CRO-independent use.

Checklist for CRO-independent EDC selection

Integrated eConsent, ePRO, and EDC in one platform and one audit trail
21 CFR Part 11–aligned controls and HIPAA-aligned security
Study builder or rapid deployment; no CRO dependency for system build
Documentation and support for sponsor validation
Pricing and contract fit for CRO-independent studies
Export for analysis and regulatory use

Common mistakes for CRO-independent trials selecting EDC

Choosing software that requires CRO for setup and operation
Not securing documentation for sponsor validation
Underestimating need for self-serve or sponsor-led build
Not clarifying pricing and contract for CRO-independent use

Where Capture fits for CRO-independent trials

Single platform for EDC, eConsent, ePRO, and safety; study builder for sponsor or site-led build
21 CFR Part 11–aligned controls and HIPAA-aligned security; documentation for validation (Enterprise)
Run studies without CRO dependency; book a demo to evaluate fit

Clinical trial software without CRO EDC for clinical trial sponsors Features

FAQ

Questions we hear a lot

What EDC fits CRO-independent trials?

Look for one platform for EDC, eConsent, and ePRO with study builder and documentation for sponsor validation—so you can build and run without a full-service CRO. Capture supports CRO-independent use; book a demo.

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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