Optimization of a Complex Randomization and Supply Management Process

“The Medidata team was focused on meeting key study needs—not just when we were getting the study started, but during the entire process. They were always adapting and improving strategies in real time.”
Clinical Operations Lead for the sponsor

The Challenge

A mid-sized pharmaceutical company was preparing a pioneering Phase II oncology study that included modified dose escalation of a novel therapy for oral pre-malignant lesions. The sponsor initially engaged with Medidata to manage the randomization study build, however during the project initiation meeting it became clear they needed resources for both randomization study build and supply management components.

Due to limited internal resources to support the complex supply management process, and a limited drug supply, the sponsor engaged Medidata’s Rave RTSM cross-segment team to manage all post go-live study conduct activities alongside the integrated platform capabilities of Rave EDC and Rave RTSM.

The Solution 

Medidata’s Rave RTSM cross-segment team provided immediate consulting support to help the sponsor navigate a complex supply management process. The team of experts was able to quickly understand the study needs, determine the sponsor’s supply management experience, identify gaps, and propose the go-live management processes. 

Working with the clinical supply manager, the Rave RTSM cross-segment team optimized the supply chain to conserve drug supply and maintain shipments to manage all of the cohorts. “Medidata excelled in coming up with creative solutions to fit our needs,” said the Clinical Operations Lead for the sponsor, which included complex re-supply requirements, as well as finding the appropriate drug supply balance without overshipping or under supplying a site. Having a dedicated Medidata RTSM Subject Matter Expert working with the supply manager on managing daily forecasting risks allowed the sponsor to focus on other critical tasks. 

The Results

The study’s success was a direct result of the collaboration between Medidata’s Rave RTSM cross-segment team, the sponsor, the CRO and the supply manager. The Medidata team provided deep expertise and knowledge of supply chain management, and when coupled with industry partners, this allowed the sponsor to reallocate resources to focus on what is most important — clinical research.

The integration of Rave EDC and Rave RTSM was a valuable component of the automated dispensation plan. The workflow from Rave EDC to Rave RTSM was optimized for the sponsor and the site staff by having only one point of data entry. Integrated platform capabilities eliminated data reconciliation in separate systems, and the integration was favorable for supply chain stakeholders, including the depot manager.