Case Study: Global Pharmaceutical Company achieves regulatory approval for bronchodilator after proving efficacy with Clario

Global pharmaceutical company proves efficacy of bronchodilator for COPD patients

Global Pharmaceutical Company ran a program of clinical trials to demonstrate that a new bronchodilator delivered superior and sustained lung function (FEV1) for COPD patients while capturing patient‑reported outcomes and reducing reliance on rescue medication. Clario supported the sponsor with integrated Respiratory, eCOA, Cardiac Safety and Enhanced Business Intelligence solutions, including MasterScope™, the Clario EXPERT® platform and AM3TM for home monitoring and ePRO.

Clario centralized spirometry overread, home monitoring/eDiary and ECG collection, and applied Enhanced Business Intelligence to monitor data quality, establishing baselines prior to randomization, detecting exacerbations via patient and investigator alerts, and identifying worsening symptoms. Those capabilities produced a robust assessment of treatment effects and helped the Global Pharmaceutical Company secure new drug approval from U.S. and European regulatory authorities.