Randomization Software for Small Studies

Randomization software for small studies: 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 Software for Small Studies

Randomization software for small studies provides treatment assignment with allocation logged and auditable—with 21 CFR Part 11–aligned controls when integrated with EDC and eConsent. Small studies need randomization without enterprise IVRS/IWRS overhead. 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; built for small studies.

What randomization software for small studies does

Small studies need treatment assignment with full audit trail—without enterprise IVRS/IWRS complexity. 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 for small studies

Enterprise IVRS/IWRS: complexity and cost for small studies
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; fit for small studies

Capture fit for randomization for small studies

Configurable randomization in same platform as EDC, eConsent, ePRO; built for small studies
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 Randomization without CRO Features

FAQ

Questions we hear a lot

What is randomization software for small studies?

Randomization software for small studies provides treatment assignment with full audit trail—with 21 CFR Part 11–aligned controls—without enterprise IVRS/IWRS overhead. 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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