bioaccess® can assess an early feasibility study in Venezuela — pilot device work in small patient cohorts before a larger traditional feasibility or pivotal program. We are a first-in-human CRO founded in 2010. INHRR (Instituto Nacional de Higiene “Rafael Rangel”), under the Ministry of Popular Power for Health (MPPS), is the technical authority on the file; institutional ethics review varies by study (we confirm it per protocol) on early-phase studies. A study is confirmed for the proposed protocol — designed with FDA submission in mind under 21 CFR 812.28.
bioaccess® can assess an early feasibility study in Venezuela: pilot investigations of a device in a small number of subjects to gather early clinical safety and performance signals before committing to a larger program. Miami headquarters, in-country operations — a first-in-human CRO founded in 2010.