Reata's Use of Medidata Rave RTSM in Clinical Trials

This case study details Reata's implementation of Medidata Rave RTSM for a Phase-II cardiovascular clinical trial characterized by a complex adaptive design. The document outlines the challenges faced by Reata in finding a suitable randomization and trial supply management solution that could accommodate evolving study requirements, including dose adjustments and cohort size changes. Reata selected Medidata Rave RTSM due to its flexibility, ease of use, and integration with existing systems, which allowed for rapid setup and real-time modifications during the trial. The case study presents significant outcomes, including cost savings from merging three studies into one, completing study setup in two days, and minimizing risks associated with traditional coding methods. Additionally, it highlights the value of Medidata's Professional Services team in facilitating the implementation process, ensuring that Reata's specific needs were met efficiently. The overall impact of Rave RTSM on Reata's trial execution and operational efficiency is emphasized throughout the document.