Randomization Tools for Clinical Trials

Randomization tools for clinical trials: treatment assignment with 21 CFR Part 11–aligned controls. Common methods, workflow, Capture fit.

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

Overview

Randomization Tools for Clinical Trials

Randomization tools for clinical trials provide treatment assignment with allocation logged and auditable—with 21 CFR Part 11–aligned controls when integrated with EDC and eConsent. Common methods include block and stratified randomization; we explain method options simply. Workflow example: consent → allocation → CRFs in one platform. Capture fit: configurable randomization in same platform as EDC, eConsent, and ePRO; allocation logged and auditable.

What randomization tools do and common methods

Randomization tools assign treatment per protocol and log allocation with full audit trail. Common methods include block and stratified. When 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.

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
Export for analysis and regulatory use
Documentation to support sponsor validation when required (Enterprise)

Without integrated randomization tools

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

Capture fit for randomization tools

Configurable 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

Clinical trial randomization software Block randomization software Features

FAQ

Questions we hear a lot

What are randomization tools for clinical trials?

Randomization tools assign treatment per protocol and log allocation with full audit trail—with 21 CFR Part 11–aligned controls. Capture includes configurable randomization in the same platform as EDC, eConsent, and ePRO.

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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