Supporting Seamless Execution Across Early Phase Alzheimer's Trials
This case study examines the operational challenges of managing multi-site early-phase Alzheimer's clinical trials during the COVID-19 pandemic. It highlights how streamlined oversight and improved communication helped the program meet its timeline and budget goals.
Advancing a novel Alzheimer's treatment through three consecutive early-phase studies across 18 sites is a complex undertaking under any circumstances. During the COVID-19 pandemic, the program faced compounding obstacles, including participant hesitancy to enroll, inefficiencies introduced by intermediary consultant layers, high turnover among vendor support staff, and compressed timelines for single- and multiple-ascending-dose studies. This study reviews how the program overcame these hurdles by streamlining oversight and maintaining near-daily sponsor communication, completing the entire early-phase program on time and on budget.
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