Case Study: Large Pharmaceutical Company achieves accelerated FDA approval for Alzheimer’s treatment with Clario

Clario supports large pharmaceutical company with a complex Alzheimer’s disease study

Large Pharmaceutical Company faced the challenge of proving safety and efficacy for a novel Alzheimer’s treatment across global Phase I–III trials in 15 countries, requiring large volumes of highly precise, standardized MRI, PET and ECG data plus expert management of endpoints and adverse events. They engaged Clario to provide neuroscience expertise and imaging and cardiac safety data services to support the program from protocol development through regulatory submission.

Clario implemented standardized global data acquisition, QC and centralized analysis—collecting and managing over 35,000 MRI and amyloid PET time points from 1,200 sites and more than 20,000 ECGs, training site staff, shipping devices and providing a study portal—while centrally reviewing images and ECGs. As a result, the sponsor achieved accelerated FDA approval in 2023; Clario continues to support the company toward full approval and to lead industry education on ARIA, demonstrating clear regulatory and operational impact.