RTSM

CIMS Global's Randomization and Trial Supply Management System (RTSM) is a comprehensive platform designed to manage the full lifecycle of clinical trial subject management, from registration and screening through enrollment, randomization, and study supply distribution. Built for sponsors and clinical research organizations, the system offers unique capabilities to support innovative trial designs and highly customized enrollment processes.

CIMS' RTSM is engineered to reduce operational complexity while strengthening data integrity and blinding protections, making it suitable for a wide range of clinical trial types and complexity levels.

Key Features

• Flexible Screening and Enrollment Process: The system is easily configurable to accommodate a variety of enrollment procedures, allowing sponsors to tailor the process to their specific study requirements and protocols.
• Innovative Randomization Schemes: CIMS' RTSM supports advanced randomization methodologies including dynamic, adaptive, and competing randomization, as well as standard static block randomization, enabling support for both conventional and cutting-edge trial designs.
• Separate Sequences for Grouping and Packaging: Random sequences for grouping and packaging are maintained independently, which significantly reduces the number of study drug packages required and allows site inventory to be kept at a minimal level, improving supply chain efficiency.
• Stronger Protection of Blinded Data: Beyond the standard double-blind method, the system incorporates an additional layer of partial blinding between the drug supply and pharmacy, providing more effective prevention of accidental unblinding.
• Mobile App (eSite): Through CIMS' mobile application, eSite, investigators can randomize subjects, reserve drug dispenses, and perform urgent unblinding directly from a mobile device, supporting flexibility and rapid response in the field.
• Live Data Simulation: A unique pre-launch feature that allows users to validate the enrollment and randomization process through simulation before the system goes live, helping to identify and resolve issues prior to study start.

Operational and Supply Management Benefits

• Comprehensive management of subject registration, screening, and enrollment in a single integrated system.
• Minimized site inventory requirements through the separation of grouping and packaging sequences.
• Support for both standard and innovative trial designs through a broad range of configurable randomization schemes.
• Enhanced blinding safeguards that go beyond conventional double-blind protections to reduce the risk of accidental unblinding during drug supply and pharmacy interactions.

CIMS Global's RTSM is designed to integrate seamlessly into clinical trial operations, offering a configurable and scalable solution for sponsors seeking to streamline trial supply management while maintaining rigorous data integrity and compliance standards. Organizations interested in learning more can schedule a demo directly with the CIMS team.