Software Stack for Running a Clinical Trial

Software stack for running 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

Software Stack for Running a Clinical Trial

A software stack for running a clinical trial typically includes EDC, eConsent, ePRO, and often enrollment and randomization—in one platform with 21 CFR Part 11–aligned controls. Overview: teams need to map the stack 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 software stack for running a trial includes 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

Digital tools for clinical researchTools needed to run a clinical trialFeatures

FAQ

Questions we hear a lot

What is the software stack for running a clinical trial?
The software stack typically includes EDC, eConsent, ePRO—and often enrollment and randomization—in one platform 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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