bioaccess® can assess a medical device study in Venezuela — first-in-human, early feasibility, and traditional feasibility programs. We are a first-in-human CRO founded in 2010. Two files, two authorities: INHRR (Instituto Nacional de Higiene “Rafael Rangel”), under the Ministry of Popular Power for Health (MPPS), authorizes the clinical investigation; SACS (Servicio Autónomo de Contraloría Sanitaria) handles commercial device registration on a timeline that varies by study (we confirm it per protocol) — a second, separate 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 a medical device study in Venezuela: Miami headquarters, in-country operations, a first-in-human CRO founded in 2010. Device work here means two files with two authorities — and sponsors get in trouble when they confuse them.