Randomization

OpenClinica's Randomization module is a fully integrated clinical trial randomization solution designed to eliminate the complexity and delays associated with managing randomization through separate systems or manual processes. Built directly into the OpenClinica EDC platform, it enables sponsors, CROs, academic researchers, and site coordinators to configure, generate, and manage randomization schemes without relying on third-party vendors or standalone tools.

Whether running a simple randomized controlled trial or a complex adaptive multi-site study, OpenClinica Randomization supports the full spectrum of trial designs. Sites can randomize subjects in real time directly within a CRF, with drug or randomization codes auto-generating and populating into the study database instantly—eliminating manual entry errors and reducing delays across the study team.

Who It Is For

• Academic Researchers: Run complex adaptive designs without depending on separate statisticians or third-party vendors for every randomization list.
• Sponsors and CROs: Manage multiple treatment arms, stratification variables, and re-randomization across multi-site studies—all within a single EDC platform.
• Sites and Coordinators: Randomize subjects in seconds with auto-generated codes that flow directly into CRFs, with no manual entry required.

Randomization Methods and Configuration

• Supports multiple randomization methods including simple, block, random permuted block, and minimization—accommodating whatever the protocol requires.
• Stratify by any CRF variable such as age, sex, site, or custom fields, with no limit on the number of stratification factors.
• Unlimited treatment groups with fully customizable allocation ratios.
• Expert statisticians are available to guide users through scheme setup, ensuring the design is configured correctly from the start.

Key Features

• Auto-generated randomization codes that populate directly into the study database.
• Code list management for treatment kit labeling.
• Support for both blinded and unblinded study designs, with complete code list management for blinded trials.
• Follow-up visit code allocation for studies requiring multiple randomizations.
• Generated and centrally managed randomization lists with full audit trails.
• Automated email notifications to keep study teams and sites informed as randomization events occur.
• Real-time allocation tracking and status visibility.
• Complete audit trail that is 21 CFR Part 11 compliant.
• Fully integrated with OpenClinica EDC—no separate systems required.
• Transparent, modular pricing designed to fit varying study volumes.

How It Works

1. Configure your randomization scheme: Set the method, stratification variables, treatment groups, and allocation ratios. OpenClinica's statisticians can assist with setup to ensure accuracy.
2. Generate and manage lists: Create randomization lists and code lists for labeling treatment kits, managed centrally with full audit trails.
3. Randomize subjects in real time: Sites randomize directly within a CRF, with drug or randomization codes auto-generating and instantly populating into the study database.
4. Track and notify automatically: Monitor allocation status in real time, with automated email notifications keeping all relevant study team members and sites informed.

Ideal Use Cases

• Randomized controlled trials (RCTs)
• Adaptive trial designs
• Multi-arm and multi-stage studies
• Stratified randomization protocols
• Blinded and unblinded studies
• Studies requiring multiple randomizations
• Trials with follow-up visit allocations
• Teams managing their own randomization lists internally

OpenClinica Randomization is trusted by more than 1,500 sponsors, CROs, and research sites worldwide. As a natively integrated component of the OpenClinica platform, it works seamlessly alongside EDC, eConsent, eCOA, and EHR-to-EDC capabilities, providing a unified and compliant environment for end-to-end clinical trial management.