bioaccess® can assess a first-in-human study in Venezuela for the proposed protocol. We are a first-in-human CRO founded in 2010 — 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 varies by study (we confirm it per protocol) on first-in-human and early-phase studies; the complete INHRR file sits in a study-specific band from submission to authorization. A study is confirmed for the proposed protocol — 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 a first-in-human CRO founded in 2010. That is the identity already on the live Venezuela blogs — not a Venezuelan legal entity we do not publish, and not a country we talk sponsors out of.