Case Study: Global Pharmaceutical Company achieves accelerated FDA approval in non-small cell lung cancer with Clario

Clario supports accelerated FDA approval in non-small cell lung cancer study

Global Pharmaceutical Company was running a Phase I non‑small cell lung cancer (NSCLC) study across North America, the EU and APAC and faced significant reader variability and accumulated delays after working with an alternative imaging vendor. To address this, the sponsor engaged Clario for rapid retrospective image QC and analysis, leveraging Clario’s expert-led imaging services and external reader network.

Clario executed a two‑month retrospective QC and analysis of CT CAP images, deployed a harmonized reader paradigm (two radiologists with adjudicator/oncologist support), and used its 190+ expert reader network and project teams to reconcile images from the prior vendor. The work enabled an accelerated FDA approval, a successful on‑site FDA inspection in January 2021, and led the Global Pharmaceutical Company to expand Clario’s role and award multiple additional NSCLC studies.