Skip to main content
Clinical Research Platform

Randomization Engine

Statistically rigorous randomization as a standalone service.

A validated randomization core exposed via API and UI — for sponsors who need sophisticated allocation (stratification, minimization, adaptive designs) inside their own ecosystem or embedded in Capacia RTSM.

randomization.capacia.cloud
30-day activity▲ trending up
Permuted block, stratified and covariate-adaptive
Central and site-stratified allocation with
Simulation workbench to validate design
Sealed-envelope compatible emergency code-break workflow
System statusAll systems operational

Capabilities

What Randomization Engine does

Permuted block, stratified and covariate-adaptive minimization

Central and site-stratified allocation with audit-proof seeds

Simulation workbench to validate design balance pre-study

Sealed-envelope compatible emergency code-break workflow

REST API for embedding into any eClinical stack

Statistician review and e-signature on every schema release

Workflow

How teams run on it

1

Design

Model your protocol, visit schedule, CRFs and edit checks with versioned, CDISC-aligned study builders.

2

Capture

Collect site, patient and vendor data through EDC, ePRO/eCOA and API-driven external loads.

3

Clean & Review

Automated review rules, query management, SDV and medical coding keep data submission-ready continuously.

4

Analyze

Real-time dashboards, TFL generation and statistical compute bridges to SAS, R and Python.

5

Lock & Submit

Snapshot, e-signature sign-off, define.xml and submission package assembly with full traceability.

Benefits

Why enterprises choose Capacia

Faster time to value

Preconfigured templates, guided onboarding and migration tooling get teams productive in weeks, not quarters.

Lower total cost

One vendor, one contract, one integrated stack — retire point solutions and their integration tax.

Audit-ready always

Every action is logged, versioned and attributable. Evidence for auditors is a report, not a project.

Open by design

REST and GraphQL APIs, webhooks and event streams on every entity. Your data is never locked in.

Enterprise-grade security

SSO, RBAC, encryption in transit and at rest, and continuous security monitoring as standard.

Global scale

Multi-region deployment, 99.99% uptime SLA and 24×7 follow-the-sun support.

Security & Compliance

Randomization Engine inherits the Capacia security baseline — encryption in transit and at rest, SSO with adaptive MFA, granular RBAC and immutable audit trails — plus the certifications and frameworks your regulators expect:

21 CFR Part 11GxP / GCPHIPAAGDPRCDISC (SDTM · ADaM · ODM)ICH E6(R3)

Industries served

Documentation

Full product documentation, API references and validation packages are available to customers and evaluators — request access.

FAQs

Frequently asked questions

How is Randomization Engine deployed?

Randomization Engine is available as managed SaaS in Capacia's cloud, in your own Azure / AWS / GCP tenancy, or on-premise for regulated environments. All deployment models receive the same release cadence and support SLAs.

Does Randomization Engine integrate with our existing systems?

Yes. Every entity is exposed through documented REST and GraphQL APIs plus webhooks and event streams, and the Capacia Integration Hub ships 200+ prebuilt connectors for common enterprise systems.

What does implementation look like?

A typical rollout runs 4–12 weeks: discovery, configuration, data migration, validation and hypercare — led by a dedicated Capacia product team with a named success manager.

How is pricing structured?

Pricing is subscription-based, scaled to usage tiers within the Clinical Research Platform. Volume, multi-product and multi-year discounts are available — contact us for a tailored quote.

Is my data secure and compliant?

All products inherit Capacia's security baseline: encryption everywhere, SSO/MFA, granular RBAC, full audit trails, and compliance mappings for GDPR, HIPAA and — where applicable — 21 CFR Part 11 with validation documentation.

See Randomization Engine in action

A 30-minute demo tailored to your workflows — no slides, real product.