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.
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.