Key Takeaways Ensure your CRO has a permanent, in-country presence, not just contractors. Demand evidence of successful FDA submissions utilizing their LATAM FIH data. Verify strong, named relationshi...
Key Takeaways Ensure your CRO has a permanent, in-country presence, not just contractors. Demand evidence of successful FDA submissions utilizing their LATAM FIH data. Verify strong, named relationships with local regulatory bodies and ethics committees. Confirm their in-house capabilities for device import and customs clearance. Insist on realistic, milestone-driven timelines with clear contingency plans. Scrutinize their ICH-GCP and ISO 14155 compliance with specific protocols. Understand their documented escalation pathways for regulatory delays or issues. Approving a First-in-Human (FIH) trial, especially in a region as dynamic and promising as Latin America (LATAM), is a significant strategic decision for any medical device or pharmaceutical company. It represents a substantial investment of capital, time, and reputation. As a board member, CEO, or venture capitalist, your role is to mitigate risk while maximizing the potential for groundbreaking innovation. The CRO you partner w…