Explore best practices for FIH clinical trials in Costa Rica, focusing on efficiency and compliance.
Introduction First-in-human (FIH) clinical trials in Costa Rica offer a unique blend of challenges and opportunities for MedTech and Biopharma companies. With a robust regulatory framework governed by Law 9234 and the oversight of the National Council for Health Research (CONIS), understanding these dynamics is crucial for successful trial execution. This article explores best practices that can streamline the approval process, enhance patient recruitment, and ensure compliance with ICH-GCP standards. Ultimately, this positions Costa Rica as a strategic hub for early-stage research in Latin America. By leveraging local insights and regulatory expertise, how can companies enhance trial outcomes and expedite market entry for innovative therapies? Understand the Regulatory Landscape for FIH Trials in Costa Rica Understanding Costa Rica’s regulatory framework is essential for successful FIH clinical trial Costa Rica in the region. Governed by Law 9234, enacted in 2014 , this framewo…