Clinical Trial Platform with Randomization

Clinical trial platform with randomization: allocation, eConsent, and data capture in one platform with 21 CFR Part 11–aligned controls.

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

Overview

Clinical Trial Platform with Randomization

A clinical trial platform with randomization means treatment allocation and data capture in the same platform—allocation logged and auditable, with no separate randomization vendor for simple designs. Teams want it to keep consent, allocation, and CRFs in one audit trail. Capture provides EDC, eConsent, ePRO, and configurable randomization in one platform with 21 CFR Part 11–aligned controls. We explain method options simply and support common randomization designs (e.g., block, stratified) with full audit trail.

Why teams want a platform with randomization

Separate randomization and EDC mean two audit trails. A platform with built-in randomization gives you allocation in the same system as consent and CRFs—allocation logged and auditable. Operational benefits include one build, one audit trail, and simpler monitoring. We support common randomization methods; for advanced biostatistical designs, discuss your requirements with us.

Operational benefits of platform with randomization

One platform and one audit trail for consent, allocation, and CRFs
Configurable randomization (e.g., block, stratified); allocation logged and auditable
Same 21 CFR Part 11–aligned controls and HIPAA-aligned security for all data
Simpler monitoring and inspection readiness; export for analysis and regulatory use
Documentation to support sponsor validation when required (Enterprise)

What slows teams down without built-in randomization

Separate randomization system and integration or manual allocation
Two audit trails and reconciliation for allocation and data
Higher cost and longer implementation for randomized studies
Monitoring and compliance review across multiple systems

Capture workflow for platform with randomization

Configurable randomization in same platform as EDC, eConsent, and ePRO; allocation logged and auditable
One audit trail for all data; 21 CFR Part 11–aligned controls and HIPAA-aligned security
Study builder to configure visits, forms, and randomization; support for common designs
Export for analysis and regulatory use; documentation for validation (Enterprise)

EDC with randomization EDC with built-in ePRO Features

FAQ

Questions we hear a lot

What randomization methods does Capture support?

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

Is allocation auditable?

Yes. Randomization and allocation 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?

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