Block Randomization Software

Block randomization software: block-based 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

Block Randomization Software

Block randomization software provides block-based treatment assignment with allocation logged and auditable—with 21 CFR Part 11–aligned controls when integrated with EDC and eConsent. Common methods include fixed or variable block sizes; we explain method options simply. Workflow example: consent → allocation (block) → CRFs in one platform. Capture fit: configurable block randomization in same platform as EDC, eConsent, and ePRO; allocation logged and auditable.

What block randomization software does

Block randomization assigns treatment within blocks to balance groups. When block randomization is in the same platform as EDC and eConsent, you get one audit trail; when it’s separate, you get integration cost and two audit trails. We support common block designs; for advanced designs, discuss your requirements with us.

Workflow example

  • Consent and eligibility confirmed; block 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
  • Export for analysis and regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

Without integrated block randomization

  • Separate randomization system: two audit trails and reconciliation
  • Manual block allocation: error-prone, no single audit trail
  • Need for one platform for consent, allocation, and CRFs with one audit trail
  • Capture: configurable block randomization in same platform as EDC, eConsent, ePRO

Capture fit for block randomization

  • Configurable block randomization in same platform as EDC, eConsent, ePRO
  • 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 randomization softwareEDC with randomizationFeatures

FAQ

Questions we hear a lot

What is block randomization software?
Block randomization software assigns treatment within blocks and logs allocation with full audit trail—with 21 CFR Part 11–aligned controls. Capture includes configurable block randomization in the same platform as EDC, eConsent, and ePRO.
Is allocation auditable?
Yes. Randomization and allocation in Capture are recorded in the audit trail with the same 21 CFR Part 11–aligned controls as the rest of the study.
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.