Case Study: Global Pharmaceutical Company achieves new drug approval for COPD bronchodilator with Clario

Clario Safety & Efficacy Solutions integrated with Enhanced Business Intelligence helps secure new drug approval from global regulatory authorities

Global Pharmaceutical Company needed to prove that a new bronchodilator provided superior, sustained lung function for COPD patients while capturing patient-reported outcomes and reducing reliance on rescue medication—despite common underreporting of exacerbations. Clario supported the program with integrated Respiratory, eCOA, Cardiac Safety and Enhanced Business Intelligence solutions, including centralized spirometry (MasterScope), the EXPERT platform and AM3 home monitoring/ePRO tools.

Clario implemented centralized spirometry and overread, home eDiary monitoring via AM3 to establish baselines, trigger patient/investigator alerts for exacerbations, and collect daily symptom and ECG data, with Enhanced Business Intelligence ensuring data quality. These integrated solutions enabled detection of exacerbations, identification of worsening symptoms, and a robust assessment of treatment effects, helping the Global Pharmaceutical Company secure new drug approval from U.S. and European regulatory authorities.