IWRS

Internet-based randomization and drug supply management for clinical trials with unlimited subjects, sites, and trial duration.

Overview

Randomize.net is an internet-based randomization and drug supply management service (IWRS) for clinical trials, operated by Interrand Inc. and available since 2000. It is designed for coordinating centers, academic institutions, hospitals, and private sector sponsors who need to manage subject randomization across single or multi-site trials. The platform is fully compliant with FDA 21 CFR Part 11 and was developed under the supervision of a Professor of Biostatistics at the University of Toronto.

Randomize.net operates on a one-time activation fee model with no cost until a trial is activated. Academic and hospital-funded trials are priced at $2,500 per trial, while private sector-funded trials are priced at $4,500 per trial. Both tiers include unlimited trial duration, unlimited clinical sites, unlimited subjects, downloadable reports, and unlimited support. Additional costs may apply for trial customization and minimization algorithms.

Randomization Algorithms

Permuted blocked stratification
Minimization
Simple randomization

Trial Configuration and Management

Randomization applications can be configured with a customizable set of options and features
Supports unlimited treatment arms and stratification variables
Full support for double-blinded trials, including kit management, kit replacement, and emergency unblinding
Configurable email notifications
Real-time reports that can be viewed and downloaded

User Management

Multiple Coordinating Center user accounts can be created
User roles include Administrator, Auditor, and Kit Administrator

Systems Integration

Web Service API available for integrating randomization into external applications
API supports subject randomization and reporting functions

Compliance and Security

Fully compliant with FDA 21 CFR Part 11
Described as a highly secure internet-based service

Randomize.net is hosted and supported by Interrand Inc., based in Ottawa, Canada. The platform has been in operation since 2000 and has supported hundreds of completed trials. Sign-up is free, with activation fees due within 30 days of trial activation. Custom pricing is available for trials requiring additional customization or minimization features.