Clinical Trial Study Design Tools

Clinical trial study design tools: configure visits, forms, and logic. 21 CFR Part 11–aligned controls.

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

Overview

Clinical Trial Study Design Tools

Clinical trial study design tools let you configure visits, forms, and study logic—so you can get from protocol to live study without heavy vendor-led cycles. What teams need before launch: protocol and CRF requirements. Build workflow: design visits and forms in study builder; deploy and amend when your process allows. Traditional delays: long vendor-led design and heavy change control. Capture fit: study design tools (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 tools to design visits and forms with full audit trail. When study design tools are 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

  • Design 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 design and heavy change control
  • Dependency on vendor for design and amendments
  • Delays to first patient or first dose
  • Need for rapid design and amendments without enterprise overhead

Capture fit for study design tools

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

Related

Clinical trial study builder softwareEDC with drag-and-drop CRF builderFeatures

FAQ

Questions we hear a lot

What are clinical trial study design tools?
Study design tools let you configure visits, forms, and study logic—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).

Ready to see Capture in action?

Explore the platform with a free sandbox. No sales call required.