Protocol-to-Study Setup Software

Protocol-to-study setup 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

Protocol-to-Study Setup Software

Protocol-to-study setup software gets you from protocol to live study quickly—configure visits, forms, and logic from protocol and CRF requirements without heavy vendor-led cycles. What teams need before launch: protocol and CRF requirements. Build workflow: translate protocol to visits and forms in study builder; deploy and amend when your process allows. Traditional delays: long vendor-led setup 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 protocol-to-study setup with full audit trail. When setup 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.

Build workflow

  • Translate protocol to visits and forms 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

  • Long vendor-led protocol-to-study setup and heavy change control
  • Dependency on vendor for setup and amendments
  • Delays to first patient or first dose
  • Need for rapid setup and amendments without enterprise overhead

Capture fit for protocol-to-study setup

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

Related

Clinical trial study builder softwareEDC with automated study setupFeatures

FAQ

Questions we hear a lot

What is protocol-to-study setup software?
Protocol-to-study setup software gets you from protocol to live study quickly—with full audit trail and 21 CFR Part 11–aligned controls. Capture includes study builder in the same platform as EDC, eConsent, and ePRO.
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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