Randomization & Trial Supply Management (RTSM)

What is RTSM?

RTSM (Randomization and Trial Supply Management) systems enable study teams to manage patient randomization and supply investigational drugs, placebos, and/or medical devices to sites throughout the study lifecycle. RTSM systems are alternatively called Interactive Response Technology (IRT), which encompasses IWRS, IVRS, and IxRS (Interactive Web, Voice, and Voice/Web Response Systems).

These technologies supported site staff in obtaining study kit information, especially when computers were not widely available in surgical rooms. Today, web access is more prevalent in hospital settings, so staff may leverage centralized RTSM systems to manage patients dosages. IxRS is still commonly used throughout the world.

Patients must be assigned into different treatment arms via randomization to balance known and unknown subject attributes and demonstrate validity of statistical comparisons. This process is complicated due to Sponsor/CRO requirements such as double blindness (neither patient nor study team knowing which treatment was obtained), complex stratifications, and ability to recruit patients globally while maintaining oversight from a centralized location. With high volumes of subjects, it’s easy to incorrectly assign a randomization number or dispense the wrong treatment kit.

Unlike other clinical systems, such as CTMS and eTMF, that may be managed fully in-house, Sponsors typically rely on IRT vendors to set up studies and provide professional/validation services due to the build complexity.

Important Considerations for RTSM Implementation

Implementation and vendor selection comprise an arduous process, and Sponsors are often unsure what to ask. As novel trial and master protocol designs evolve, the complexity of these decisions will likely grow. For a successful RTSM implementation, consider the following:

• Study Build Timelines: Sometimes, the core RTSM application will not meet every need of your trial design. Allocate time for the vendor to develop custom programming to incorporate your requirements into the system.
• Vendor Expertise: Choose an experienced vendor who acts as a partner, understands your study’s unique requirements, and provides expert advice. ProPharma specializes in vendor assessment, guiding your organization through RFX and system demos to select a fit-for-purpose system.
• Functionality and Flexibility: At a minimum, ensure that the system can accommodate complex protocols, adaptive studies, multiple-subject cohorts, and advanced randomization methods as needed for your drug/therapeutic area.
• Interoperability: Many clinical trial processes are housed in disparate systems; for example, Sponsors may wish to have the randomization form in EDC and site activation conducted in CTMS. RTSM systems should offer published APIs to integrate with EDC and CTMS.

Popular Vendors in the RTSM/IRT Space

• EndPoint PULSE: with pre-validated, configurable study components, PULSE streamlines system modifications and simplifies site, user, and supply management.
• Medidata RTSM: fully pre-validated solution that enables mid-study changes and integrates seamlessly with Rave EDC.
• Suvoda IRT: offers rich functionality in cohort/stage/phase management, adaptive replacement and randomization, and drug accountability and reconciliation.
• Veeva RTSM (previously Veracity Logic): modular, quick to configure, and offers features like screening, rescreening, adaptive randomizations, and cohort management.
• YPrime IRT: provides flexible supply management, Sponsor-controlled cohort management, and easy adjustment of dispensing levels.