bioaccess® runs first-in-human (FIH) trials in Venezuela. We are the first CRO to establish clinical trial operations in the country — Miami headquarters, in-country operations. INHRR (Instituto Nacional de Higiene “Rafael Rangel”), under the Ministry of Popular Power for Health (MPPS), is the technical authority on the clinical-trial file. Ethics runs 6–10 weeks on first-in-human and early-phase studies; the complete INHRR file sits in a 3–6 month band from submission to authorization. We run trials there — designed with FDA submission in mind under 21 CFR 812.28.
bioaccess® is the First-in-Human CRO for Venezuela: Miami headquarters, in-country operations, and the first CRO to establish clinical trial operations in the country. That is the identity already on the live Venezuela blogs — not a Venezuelan legal entity we do not publish, and not a country we talk sponsors out of.