How to Run a Clinical Trial Without a CRO

How to run a clinical trial without a CRO: 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

How to Run a Clinical Trial Without a CRO

You can run a clinical trial without a full-service CRO by using one platform for EDC, eConsent, ePRO, and enrollment—so you build and operate the study yourself with 21 CFR Part 11–aligned controls. Quick answer: use software that supports sponsor- or site-led build and operation. Steps: define protocol and CRF requirements; choose one platform for consent and data capture; build study and run validation/UAT if regulated; launch and operate. Common blockers: CRO-tied software, 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; no CRO dependency for system build and operation.

Quick answer and steps

Running a trial without a CRO means you need 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. Lead with a direct answer and numbered steps.

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

  • Software that requires CRO for setup and operation
  • Long implementation and dependency on CRO for build
  • Need for one platform that sponsor or site can build and run
  • Capture: study builder; no CRO dependency for system build

Tool options and Capture fit

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

Related

Clinical trial software without CROEDC for CRO-independent trialsFeatures

FAQ

Questions we hear a lot

Can I run a clinical trial without a CRO?
Yes. You can run a trial without a full-service CRO by using one platform for EDC, eConsent, ePRO, and enrollment that you can build and operate. Capture includes study builder and documentation for sponsor validation (Enterprise).
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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