Software to Manage a Clinical Trial

Software to manage a clinical trial: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR Part 11–aligned controls.

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

Overview

Software to Manage a Clinical Trial

Software to manage a clinical trial should provide one platform for EDC, eConsent, ePRO, and enrollment—so you can build and operate the study with 21 CFR Part 11–aligned controls. Quick answer: use one system for consent and data capture. Steps: define protocol and CRF requirements; choose one platform; build study and run validation/UAT if regulated; launch and operate. Common blockers: multiple systems, long implementation. Tool options: look for study builder, integrated eConsent and ePRO, documentation for sponsor validation. Capture fit: one platform for EDC, eConsent, ePRO; study builder; documentation for sponsor validation (Enterprise).

Quick answer and steps

Managing a trial means one platform for consent and data capture that you can build and operate—with full audit trail and 21 CFR Part 11–aligned controls. Steps include defining requirements, choosing software, building the study, and launching.

Steps/process

  • Define protocol and CRF requirements
  • Choose one platform for eConsent, EDC, ePRO, and enrollment
  • Build study using study builder; run validation/UAT if regulated
  • Launch and operate; amend when your process allows
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Multiple systems for consent and data capture
  • Long implementation and vendor dependency
  • Need for one platform to manage the full trial
  • Capture: one platform for EDC, eConsent, ePRO

Tool options and Capture fit

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

Related

Tools for running a clinical trial internallyTools to launch a clinical trial fastFeatures

FAQ

Questions we hear a lot

What software do I need to manage a clinical trial?
You need one platform for EDC, eConsent, ePRO, and enrollment that you can build and operate. Capture includes study builder and documentation for sponsor validation (Enterprise); explore workflow 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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