Ethnic bridging studies can present unique recruitment and regulatory challenges, especially when highly specific inclusion criteria and cross-cultural considerations are involved. In this Phase 1 PK study, the sponsor needed to match healthy Japanese and Caucasian subjects by gender and smoking status during winter — a notoriously difficult season for Japanese clinical trial enrollment.
Clinilabs not only met the target of 20 matched subjects within 12 weeks but also exceeded expectations by enrolling 22 participants and earning a request to enroll 6 more.
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