Case Study: Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence

In an effort to enhance clinical trial operations in Japan, a leading global pharmaceutical company collaborated with Medable to address challenges related to electronic Clinical Outcome Assessment (eCOA) adherence and patient enrollment. Recognizing the unique regulatory, cultural, and logistical landscape of Japan, Medable implemented a comprehensive, culturally sensitive strategy that set a new benchmark for clinical trials in the region. Key initiatives included direct engagement with Japanese study teams, localization of all patient and site materials into Japanese, procurement of devices compliant with local regulations, and the provision of tailored training sessions in both Japanese and English.

This approach led to remarkable outcomes: eCOA adherence rates exceeded 99%, helpdesk inquiries dropped significantly, and both sites and patients reported high levels of satisfaction. Notably, the study achieved First Patient In (FPI) ahead of schedule, with all sites and Clinical Research Associates (CRAs) fully trained prior to FPI. The success of this initiative prompted the pharmaceutical company to adopt Medable's recommendations as the new standard for all studies in Japan, underscoring the effectiveness of a culturally attuned, patient-centric approach in establishing a "gold standard" for clinical trials.