EDC with Study Builder

EDC with study builder: configure visits, forms, and logic in one platform with 21 CFR Part 11–aligned controls.

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

Overview

EDC with Study Builder

EDC with study builder means you can configure visits, forms, and study logic without long vendor-led implementation. Teams want it to launch and amend studies quickly and keep control in-house. Capture provides EDC, eConsent, ePRO, and a study builder in one platform with 21 CFR Part 11–aligned controls; all changes are tracked in the audit trail and you can amend studies without lengthy change control when your process allows.

Why teams want EDC with study builder

Vendor-led build often means long timelines and heavy change control. A study builder gives you the ability to configure visits, forms, and logic—with full audit trail—so you can launch and amend studies faster. Operational benefits include rapid setup, flexible amendments, and one platform for consent, CRFs, and ePRO.

Operational benefits of study builder

  • Configure visits, forms, and logic in one platform; full audit trail for changes
  • Rapid study build and deployment; amend without lengthy vendor cycles when your process allows
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
  • One platform for EDC, eConsent, ePRO, and safety
  • Documentation to support sponsor validation when required (Enterprise)

What slows teams down without study builder

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

Capture workflow for EDC with study builder

  • Study builder to configure visits, forms, and logic; all changes in audit trail
  • One platform for EDC, eConsent, ePRO, and safety; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Rapid build and flexible amendments; documentation for validation (Enterprise)
  • Export for analysis and regulatory use

Related

EDC with drag-and-drop CRF builderRapid study setup EDCFeatures

FAQ

Questions we hear a lot

What is the study builder in Capture?
Capture includes a study builder so you can configure visits, forms, and study logic. All changes are tracked in the audit trail. For regulated studies, follow your validation and change-control procedures.
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 substantial amendments, we recommend documenting the change and, for regulated studies, following 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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