EDC with Automated Study Setup

EDC with automated study setup: rapid build and deployment with 21 CFR Part 11–aligned controls.

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

Overview

EDC with Automated Study Setup

EDC with automated or streamlined study setup lets teams build and deploy studies quickly—without months of vendor-led implementation. Teams want it to reach first patient or first dose faster. Capture provides EDC, eConsent, ePRO, and study builder in one platform with 21 CFR Part 11–aligned controls; you can build and deploy studies in weeks, and for regulated studies we provide documentation to support validation and UAT.

Why teams want automated study setup

Traditional EDC often requires long vendor-led setup. Automated or streamlined study setup means you can configure visits, forms, and logic and go live faster—with full audit trail and 21 CFR Part 11–aligned controls. Operational benefits include rapid deployment, flexible amendments, and one platform for consent, CRFs, and ePRO.

Operational benefits of automated study setup

  • Build and deploy studies in weeks rather than months
  • Study builder to configure visits, forms, and logic; full audit trail
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
  • Amend without lengthy vendor cycles when your process allows
  • Documentation to support sponsor validation when required (Enterprise)

What slows teams down without streamlined setup

  • Months of vendor-led implementation before go-live
  • Heavy change control for simple form and visit updates
  • Delays to first patient or first dose
  • Need for rapid deployment without enterprise overhead

Capture workflow for automated study setup

  • Study builder and rapid deployment; all changes in audit trail
  • One platform for EDC, eConsent, ePRO, and safety; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Build and deploy in weeks; documentation for validation (Enterprise)
  • Export for analysis and regulatory use

Related

Rapid study setup EDCEDC with study builderFeatures

FAQ

Questions we hear a lot

How fast can we set up a study in Capture?
Study build can start once you have protocol and CRF requirements. Many teams build and deploy in weeks. For regulated studies, we provide documentation to support validation and UAT (Enterprise).
Is setup automated?
Capture includes a study builder so you can configure visits, forms, and logic. We streamline setup so you can deploy without months of vendor-led implementation. All changes are tracked in the audit trail.
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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