This is an investigator initiated, 5-site, industry funded Phase 4 clinical trial to better understand the mechanism of action of FDA-approved cladribine tablets by exploring the effect on central nervous system biomarkers relevant in the relapsing forms of multiple sclerosis.
Dr. Wu, a young investigator conducting his first multicenter clinical trial as overall study PI, reached out to Trial-CARE for support in project management and coordinating center activities. Kate McNulty, MHS, facilitated the study’s start-up and has served as Project Manager, facilitating protocol development, MOP/SOP development, database design and build, IRB approvals (under a Single IRB model), as well as coordination of study drug management and set-up of MRI acquisition and upload from sites to a central repository. In addition, the PM brought onboard all external sites, including facilitation of the sub-contracting and budget processes, regulatory file set-up and collection, and site training and initiation visits.
For this study, Trial-CARE provides both clinical coordination and data coordination services, the latter in partnership with the Division of Biostatistics. The PM continues to provide ongoing study management for WU and all external performance sites.