An RTSM system that takes weeks to deploy isn’t ideal for the current age clinical trials. The ideal RTSM should be deployable within days, allowing trials to start promptly and run smoothly. Quick deployment is essential for maintaining project timelines, reducing costs, and ensuring trials start promptly.

The ideal RTSM should be fully configurable and intuitive. Configurable systems can easily accommodate protocol amendments, various randomization schemes, and diverse trial designs by eliminating the need for complex coding and significantly reducing setup time. A highly configurable system is adaptable and efficient, capable of accommodating most clinical trials without extensive customization.

A robust RTSM system should offer powerful integration capabilities to ensure seamless interoperability with clinical trial systems like EDC, CTMS, and ePRO. These integrations allows real-time data transfer across systems, minimizing errors, eliminating the need of data reconciliation, enhancing data accuracy, and optimizing operational efficiency. By facilitating a unified workflow and reducing manual interventions, a well-integrated RTSM system empowers clinical trials to achieve accurate and reliable outcomes.

When selecting an RTSM system, prioritize one that supports the dynamic needs of adaptive trials. An ideal RTSM should enable mid-study changes with ease, such as modify randomization procedures, subject replacement, dosage modifications, sample size adjustments, and trial design alterations. Additionally, in emergencies, the system should offer support for unblinding to maintain the trial’s integrity and continuity. A well-equipped RTSM system with robust adaptive trial capabilities ensures greater flexibility, allowing clinical trials to navigate evolving requirements and achieve reliable, efficient outcomes.

To support complex clinical trial protocols effectively, an RTSM system should be versatile and adaptable. It must accommodate various study designs, including crossover, sequencing, and extension studies, ensuring it meets the unique needs of each trial. The system should also offer robust cohort management capabilities and a range of randomization options, such as static, stratified, dynamic, forced, and adaptive, to provide tailored support for complex trial protocols. This ensures the system can maintain trial integrity and deliver accurate, reliable results.

An ideal RTSM system should provide comprehensive monitoring and tracking of investigational product (IP) inventory. It is essential for strategic planning and distribution, ensuring inventory levels at each trial site remain adequate. The system should also track patient registrations and IP quantities across trial centers to prevent shortages. Additionally, the RTSM should promptly alert when inventory levels fall below a threshold, facilitating timely restocking from the depot. This ensures smooth trial operations and minimizes disruptions in treatment delivery.

The RTSM system that you are choosing should comply with industry standards such as 21 CFR Part 11, GDPR, and EU Annex 11. If it’s being operated in multiple countries then the system should comply with the local regulations as well. Also, the data security should be robust and the system should have a disaster recovery plan in place to ensure continuation of trials even under unforeseen circumstances.