Clinical Trial Study Builder Software

Clinical trial study builder software: get from protocol to live study quickly. 21 CFR Part 11–aligned controls.

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

Overview

Clinical Trial Study Builder Software

Clinical trial study builder software lets teams get from protocol to live study quickly—configure visits, forms, and logic without heavy vendor-led configuration cycles. What teams need before launch: protocol, CRF requirements, and a platform that supports rapid build with full audit trail. Build workflow: configure visits, forms, and logic in study builder; deploy and amend when your process allows. Traditional delays: long vendor-led build and heavy change control. Capture fit: study builder 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 a platform that supports rapid build with full audit trail. When study builder is in the same platform as EDC and eConsent, you get one build and one audit trail; when it’s vendor-only, you get long configuration cycles and dependency.

Build workflow

  • Configure visits, forms, and logic in study builder; full audit trail for changes
  • Deploy and amend when your process allows; no lengthy vendor cycles for simple updates
  • 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

  • Long vendor-led build and heavy change control for simple form and visit updates
  • Dependency on vendor for build and amendments
  • Delays to first patient or first dose
  • Need for rapid build and amendments without enterprise overhead

Capture fit for study builder

  • Study builder in same platform as EDC, eConsent, ePRO; all changes in audit trail
  • 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

EDC with study builderRapid study setup EDCFeatures

FAQ

Questions we hear a lot

What is clinical trial study builder software?
Study builder software lets you configure visits, forms, and study logic without lengthy vendor-led build—with full audit trail and 21 CFR Part 11–aligned controls. Capture includes study builder in the same platform as EDC, eConsent, and ePRO.
Can we amend studies without vendor involvement?
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.
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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