bioaccess® runs early feasibility studies (EFS) in Venezuela — pilot device work in small patient cohorts before a larger traditional feasibility or pivotal program. We are the first CRO to establish clinical trial operations in the country. 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 runs 6–10 weeks on early-phase studies. We run trials there — designed with FDA submission in mind under 21 CFR 812.28.
bioaccess® runs early feasibility studies 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 — the first CRO to establish clinical trial operations in the country.