Software to Build Case Report Forms (CRFs)

Software to build case report forms (CRFs): configure CRFs without code. 21 CFR Part 11–aligned controls.

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

Overview

Software to Build Case Report Forms (CRFs)

Software to build case report forms (CRFs) lets you configure CRFs without code—fields, layouts, and logic in a study builder with full audit trail. What teams need before launch: protocol and CRF requirements. Build workflow: build CRFs in study builder; deploy and amend when your process allows. Traditional delays: code-based or vendor-only CRF build and heavy change control. Capture fit: CRF build in same platform as EDC, eConsent, ePRO; 21 CFR Part 11–aligned controls; documentation for sponsor validation (Enterprise).

What teams need before launch

Teams need protocol and CRF requirements, then software to build CRFs with full audit trail. When CRF build is in the same platform as EDC and eConsent, you get one build and one audit trail; when it’s code-based or vendor-only, you get long configuration cycles.

Build workflow

  • Build CRFs in study builder; full audit trail for changes
  • Deploy and amend when your process allows
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • One platform for EDC, eConsent, ePRO, and safety
  • Documentation to support sponsor validation when required (Enterprise)

Traditional delays

  • Code-based or vendor-only CRF build and heavy change control
  • Dependency on vendor or IT for CRF build and amendments
  • Delays to first patient or first dose
  • Need for rapid CRF build and amendments without enterprise overhead

Capture fit for CRF build

  • Study builder to build CRFs; same platform as EDC, eConsent, ePRO
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Rapid build and flexible amendments; documentation for validation (Enterprise)
  • Explore study setup or book a demo

Related

CRF builder for clinical trialsEDC with drag-and-drop CRF builderFeatures

FAQ

Questions we hear a lot

What is software to build case report forms (CRFs)?
Software to build CRFs lets you configure case report forms without code—with full audit trail and 21 CFR Part 11–aligned controls. Capture includes study builder in the same platform as EDC, eConsent, and ePRO.
Do I need to code to build CRFs?
No. You can build and amend CRFs in the study builder without code. For regulated studies, follow your validation and change-control procedures.
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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