A step-by-step practical guide for pharmaceutical and medical device sponsors looking to conduct clinical trials in Venezuela, covering INHRR regulatory submissions, private hospital site selection, ethics committee requirements, expected timelines, and operational considerations including currency and language.
Key Takeaways 6 steps from CRO engagement to patient enrollment Focus site selection on private hospitals in Caracas, Valencia, Maracaibo, and Barquisimeto Ethics committee approval is a prerequisite for INHRR CTA submission All documents must be in Spanish — bioaccess® provides certified translation Foreign sponsors must appoint a local authorized representative — bioaccess® serves this role Expected timeline: 18-33 weeks from CRO engagement to first patient enrolled Pre-submission meetings with INHRR can significantly reduce review timelines For pharmaceutical and medical device sponsors considering clinical trials in Venezuela , this practical guide provides a step-by-step roadmap from initial planning through study close-out. Step 1: Engage a Local CRO with Venezuelan Regulatory Expertise The single most important decision is choosing the right CRO partner. Venezuela's regulatory landscape requires local expertise that international CROs without in-country presence cannot provide.…