Tools Needed to Run a Clinical Trial

Tools needed to run a clinical trial: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR Part 11–aligned controls.

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

Overview

Tools Needed to Run a Clinical Trial

Tools needed to run a clinical trial include EDC, eConsent, ePRO, and often enrollment and randomization—in one platform with 21 CFR Part 11–aligned controls. Overview: teams need to map the tools to launch or run a study. Tool categories: consent, data capture, ePRO, enrollment, randomization. What teams actually need: one platform, full audit trail, documentation for validation. Capture fit: one platform for EDC, eConsent, ePRO; study builder; documentation for sponsor validation (Enterprise).

Overview and tool categories

The tools needed to run a trial include consent, data capture, ePRO, enrollment, and (when needed) randomization. What teams actually need is one platform with 21 CFR Part 11–aligned controls and documentation for sponsor validation.

Tool categories

  • eConsent: version control, e-signature, one audit trail
  • EDC: CRFs, visits, one audit trail
  • ePRO: questionnaires, diaries, one audit trail
  • Enrollment: screening, consent, one audit trail
  • Randomization: allocation logged and auditable (when required)

What teams actually need

  • One platform instead of multiple vendors
  • Full audit trail and 21 CFR Part 11–aligned controls
  • Documentation for sponsor validation when required
  • Capture: one platform for EDC, eConsent, ePRO

Capture fit

  • One platform for EDC, eConsent, ePRO; study builder
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore platform or book a demo

Related

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FAQ

Questions we hear a lot

What tools are needed to run a clinical trial?
You typically need one platform for EDC, eConsent, ePRO—with 21 CFR Part 11–aligned controls. Capture offers one platform; explore platform or book a demo.
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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