Summary
This case study outlines Clario's involvement in a Phase I non-small cell lung cancer (NSCLC) study initiated by a global pharmaceutical company in 2017. The study faced challenges related to reader variability and delays due to the incumbent imaging vendor. In 2020, Clario was engaged to conduct a rapid two-month retrospective image quality control (QC) and analysis to meet accelerated FDA timelines. The study highlights Clario's deployment of an expert team, including radiologists and oncologists, and their extensive external reader network to ensure accurate imaging reads. Clario's approach included reader harmonization through onboarding and training, as well as a smooth transition from the previous vendor. The successful execution of the project not only facilitated accelerated FDA approval but also led to a successful on-site FDA inspection in January 2021. Consequently, the sponsor expanded Clario's role to include full site-facing responsibilities and awarded additional NSCLC studies.
