Randomization / IWRS

Integrated randomization and IWRS with simple, block, and permuted block methods for clinical trial enrollment and patient cohort assignment.

Overview

TrialStat EDC includes an integrated Interactive Web Response System (IWRS) and randomization module designed to manage patient enrollment and treatment assignment within a single platform. The module is intended for clinical trial teams who need to handle randomization of any complexity without relying on a separate, standalone IWRS system.

The randomization functionality is tied directly into the EDC workflow, connecting with screening criteria such as inclusion/exclusion checks and qualifying metrics like pain scores to assign patients to cohorts. Sites can trigger randomization codes without leaving the TrialStat EDC environment. TrialStat also offers Randomization and Supply Management as a standalone service for sponsors using a different EDC system.

Randomization Methods Supported

Simple randomization
Block randomization
Permuted block randomization

Key Randomization and IWRS Capabilities

Full integration with the EDC — no separate software system required
Supports any degree of randomization complexity
Multiple levels of stratification
Randomization into different patient cohorts
Integration with inventory management
Randomization notifications
Randomization and patient enrollment status tracking
21 CFR Part 11 compliant

Broader TrialStat EDC Platform Features

eConsent module
ePRO / eCOA (Electronic Patient Reported Outcomes) module
Medical coding module
Pharmacovigilance — AE and SAE tracking
Vendor Neutral Imaging Archive (VNA) with DICOM image viewer
Fully customizable eCRFs and data review status workflows
Dynamic skip logic and comprehensive edit checks
Real-time data visualization, monitoring, reporting, and validation
40+ standard reports with configurable reports and dashboards
Multi-lingual support
Browser-based and mobile responsive interface
Bar code integration
Configurable study workflow with a typical 2–4 week build time
CTMS integration via SimpleTrials
Ability to replicate entire studies

The platform is designed to operate from rapid database build through database lock. Randomization and Supply Management services are available independently for organizations using a third-party EDC, allowing TrialStat to support those workflows without requiring a full platform migration.