Expanding clinical trials into new territories offers sponsors access to diverse patients, cost efficiencies, regulatory flexibility, and untapped markets. Success requires robust local expertise, infrastructure assessment, and careful planning. Key factors include patient recruitment tailored to cultural contexts, strong site intelligence, reliable logistics, and compliance with local regulations. Balancing full-service (FSO) and functional service provision (FSP) models ensures agility and scale. With AI-driven enrollment modeling, integrated risk-based monitoring, and localized engagement, sponsors can accelerate approvals, optimize trial delivery, and generate more representative data for global healthcare.

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