Clinical Trial Randomization Software
Clinical trial randomization software: treatment assignment with 21 CFR Part 11–compliant controls. Common methods, workflow, Capture fit.
21 CFR Part 11 compliant · HIPAA-compliant 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–compliant 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–compliant 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–compliant controls and HIPAA-compliant security
- One audit trail for consent, allocation, and data capture
- Documentation for sponsor validation (Enterprise); explore randomization or book a demo
FAQ
Questions we hear a lot
What is clinical trial randomization software?
What randomization methods does Capture support?
Is Capture 21 CFR Part 11–compliant?
Ready to see Capture in action?
Explore the platform with a free sandbox. No sales call required.
Explore randomization