Randomization Without CRO

Randomization without CRO: treatment assignment with 21 CFR Part 11–aligned controls. Integrated with EDC and eConsent.

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

Overview

Randomization Without CRO

Randomization without CRO means treatment assignment in a platform you can operate without depending on a CRO for randomization—with 21 CFR Part 11–aligned controls when integrated with EDC and eConsent. Allocation is logged and auditable. Common methods include block and stratified; we explain method options simply. Capture fit: configurable randomization in same platform as EDC, eConsent, and ePRO; allocation logged and auditable; no CRO dependency for randomization.

What randomization without CRO means

Sponsor- or site-led trials need treatment assignment without CRO-led randomization. When randomization is in the same platform as EDC and eConsent, you get one audit trail and no CRO dependency for allocation; when it’s separate, you may depend on CRO or external system.

Workflow example

  • Consent and eligibility confirmed; allocation in same platform as EDC and eConsent
  • Allocation logged and auditable; 21 CFR Part 11–aligned controls
  • CRFs and follow-up in same platform; one audit trail
  • Run randomization without CRO dependency
  • Documentation to support sponsor validation when required (Enterprise)

Without randomization without CRO

  • CRO-led randomization: dependency and cost for sponsor-led trials
  • Separate randomization system: two audit trails and reconciliation
  • Need for one platform for consent, allocation, and CRFs with one audit trail
  • Capture: configurable randomization in same platform as EDC, eConsent, ePRO; no CRO dependency

Capture fit for randomization without CRO

  • Configurable randomization in same platform as EDC, eConsent, ePRO; no CRO dependency for allocation
  • Allocation logged and auditable; 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • One audit trail for consent, allocation, and data capture
  • Documentation for sponsor validation (Enterprise); explore randomization or book a demo

Related

Clinical trial software without CROClinical trial randomization softwareFeatures

FAQ

Questions we hear a lot

What is randomization without CRO?
Randomization without CRO means treatment assignment in a platform you can operate without a CRO—with 21 CFR Part 11–aligned controls. Capture includes configurable randomization in the same platform as EDC, eConsent, and ePRO; no CRO dependency for allocation.
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.