Clinical Trial Software Without CRO

Clinical trial software without CRO: run studies with EDC, eConsent, ePRO, and 21 CFR Part 11–aligned controls when you don’t use a CRO.

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

Overview

Clinical Trial Software Without CRO

Clinical trial software without CRO means you can run studies when you’re not using a full-service CRO—one platform for EDC, eConsent, ePRO, and safety so sponsor or site-led teams can build and run studies with 21 CFR Part 11–aligned controls. Teams want it for investigator-led, small biotech, or sponsor-led trials. Capture provides EDC, eConsent, ePRO, and study builder in one platform with documentation to support sponsor validation when required; you can run studies without depending on a CRO for system build and operation.

Why teams want software that works without a CRO

Some trials are run by sponsors or sites without a full-service CRO. You need one platform that supports build, consent, data capture, and ePRO—with full audit trail and 21 CFR Part 11–aligned controls—so you can operate the study in-house or with limited CRO involvement. Operational benefits include one system, rapid build, and documentation for sponsor validation.

Operational benefits when not using a CRO

One platform for EDC, eConsent, ePRO, and safety; one audit trail
Study builder to configure visits, forms, and logic; build and run without CRO dependency for system
Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
Documentation to support sponsor validation when required (Enterprise)
Export for analysis and regulatory use

What slows teams down without CRO-agnostic software

Software tied to CRO contracts or CRO-led implementation only
Need to run studies in-house or with limited CRO involvement
Need for one platform that sponsor or site can operate
Need for 21 CFR Part 11–aligned controls without CRO dependency

Capture workflow without CRO

One 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 for system build and operation
Export for analysis and regulatory use

Self-serve clinical trial software EDC for investigator-initiated trials Features

FAQ

Questions we hear a lot

Can we use Capture without a CRO?

Yes. Capture is a platform you can use when running studies without a full-service CRO. You get EDC, eConsent, ePRO, and study builder with 21 CFR Part 11–aligned controls and documentation to support sponsor validation (Enterprise).

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).

Who can build studies in Capture?

Sponsors, sites, or CROs can build and run studies in Capture. The study builder lets you configure visits, forms, and logic; all changes are tracked in the audit trail.

Ready to see Capture in action?

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