Best Practices For Randomization And Trial Supply Management (RTSM)

The RTSM has critical functions including dispensing drug and randomizing patients, with direct patient impact. As clinical trials are becoming more complex, the reliance on these systems to function as intended is growing in importance and is becoming more top of mind to regulators.

However, when it comes to the management of these systems there is a wide range of processes utilized by sponsors and no industry standard exists. In many organizations there are RTSM standards, but across organizations they are managed very differently based on a variety of aspects, including:

• Internal RTSM knowledge and experience
• Trial scope and complexity, ability to standardize
• Organizational structure
• Size, function that manages the RTSM (clinical, supply, data management)
• Existing clinical systems and/or clinical data strategy
• Collaboration with external partners
• Fully outsourced, SaaS/Tech transfer, technology platform differences

The goal of this white paper is not to establish an industry standard, but rather to present best practices that can be applied regardless of the factors mentioned above. There are demonstrable benefits to defining a RTSM strategy surrounding best practices for quality and compliance, RTSM system design/specification process, user acceptance testing (UAT), system change management and study close-out. Guidelines around RTSM project management, supply chain and data management strategies are also discussed.