Rapid Study Setup EDC

Rapid study setup EDC: build and deploy studies in weeks with eConsent, ePRO, and 21 CFR Part 11–aligned controls.

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

Overview

Rapid Study Setup EDC

Rapid study setup EDC means you can build and deploy studies in weeks rather than months—without sacrificing 21 CFR Part 11–aligned controls or integrated eConsent and ePRO. Teams want it to reach first patient or first dose faster. Capture provides EDC, eConsent, ePRO, and study builder in one platform; you can build and deploy quickly, and for regulated studies we provide documentation to support validation and UAT.

Why teams want rapid study setup

Traditional EDC often requires long implementation. Rapid study setup means you can configure visits, forms, and logic and go live in weeks—with full audit trail and 21 CFR Part 11–aligned controls. Operational benefits include faster time to first patient, flexible amendments, and one platform for consent, CRFs, and ePRO.

Operational benefits of rapid study setup

Build and deploy studies in weeks; study builder to configure visits, forms, and logic
Full audit trail for all changes; 21 CFR Part 11–aligned controls and HIPAA-aligned security
One platform for EDC, eConsent, ePRO, and safety
Amend without lengthy vendor cycles when your process allows
Documentation to support sponsor validation when required (Enterprise)

What slows teams down without rapid setup

Months of implementation before go-live
Heavy change control for simple updates
Delays to first patient or first dose
Need for speed without sacrificing compliance

Capture workflow for rapid study setup

Study builder and rapid deployment; all changes in audit trail
One platform for EDC, eConsent, ePRO, and safety; 21 CFR Part 11–aligned controls and HIPAA-aligned security
Build and deploy in weeks; documentation for validation (Enterprise)
Export for analysis and regulatory use

EDC with automated study setup Clinical trial software with instant study setup Features

FAQ

Questions we hear a lot

How fast can we set up a study in Capture?

Study build can start once you have protocol and CRF requirements. Many teams build and deploy in weeks. For regulated studies, we provide documentation to support validation and UAT (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).

Can we amend studies quickly?

You can update forms, visits, and logic in the study build. Changes are tracked in the audit trail. For regulated studies, follow your validation and change-control procedures.

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