Clinical Trial Workflow Software

Clinical trial workflow 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 Workflow Software

Clinical trial workflow software supports the path from protocol to live study—configure visits, forms, and logic with full audit trail and 21 CFR Part 11–aligned controls. What teams need before launch: protocol and CRF requirements. Build workflow: configure workflow in study builder; deploy and amend when your process allows. Traditional delays: long vendor-led build and heavy change control. Capture fit: workflow and 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 software that supports workflow from build to go-live with full audit trail. When workflow software 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

  • Configure visits, forms, and logic 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 build and heavy change control for simple 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 clinical trial workflow

  • Study builder and workflow 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

Clinical trial study builder softwareRapid study setup EDCFeatures

FAQ

Questions we hear a lot

What is clinical trial workflow software?
Clinical trial workflow software supports the path from protocol to live study—with full audit trail and 21 CFR Part 11–aligned controls. Capture includes study builder and workflow 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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