Clinical Trial Randomization Software

Clinical trial randomization software: 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

Clinical Trial Randomization Software

Clinical trial randomization software provides treatment assignment with allocation logged and auditable—with 21 CFR Part 11–aligned controls when integrated with EDC and eConsent. What randomization software does: assigns treatment per protocol, logs allocation, and keeps one audit trail. Common methods include block and stratified randomization; we explain method options simply and avoid implying advanced biostatistical capabilities unless supported. 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 software does and common methods

Randomization software assigns treatment per protocol and logs allocation with full audit trail. Common methods include block and stratified randomization. We support common designs; for advanced biostatistical designs, discuss your requirements with us. 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

Separate randomization system: two audit trails and reconciliation
Manual or custom 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

Configurable randomization (e.g., block, stratified) 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

EDC with randomization Clinical trial platform with randomization Features

FAQ

Questions we hear a lot

What is clinical trial randomization software?

Randomization software assigns treatment per protocol and logs 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.

What randomization methods does Capture support?

Capture includes configurable randomization (e.g., block, stratified) for common designs. Allocation is logged and auditable. For advanced biostatistical designs, discuss your requirements with us.

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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