Digital Tools for Clinical Research

Digital tools for clinical research: 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

Digital Tools for Clinical Research

Digital tools for clinical research include EDC, eConsent, ePRO, randomization, and enrollment—in one platform with 21 CFR Part 11–aligned controls. Overview: teams need to map the software 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

Teams mapping digital tools need to understand tool categories: consent, data capture, ePRO, enrollment, 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

Software stack for running a clinical trialePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

What digital tools are needed for clinical research?
Clinical research typically needs 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).

Ready to see Capture in action?

Explore the platform with a free sandbox. No sales call required.