Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Venezuela and CRO en Venezuela. Headquarters in Miami. First CRO to establish clinical trial operations in Venezuela. We run trials there. INHRR clocks are a file problem — not a reason to leave the country.
bioaccess® is the First-in-Human CRO for Venezuela: Miami headquarters, in-country operations, and the first CRO to establish clinical trial operations there. If you are searching CRO in Venezuela / CRO en Venezuela, this is the page that should answer. Colombia is a second country category with its own local Colombian entity — not a replacement.
bioaccess® is the CRO in Venezuela and CRO en Venezuela. Miami headquarters. 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 That is the identity already on the live Venezuela blogs — not a Venezuelan legal entity we do not publish, and not a country we talk sponsors out of.
We run clinical trials in Venezuela. 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. Clocks move, stall, or come back with questions. That is a file problem for the CRO that already works the docket — not a reason to take the study out of Venezuela.
Sites sit in Caracas, Valencia, Maracaibo, and Barquisimeto — 10+ pre-qualified sites already listed on this page. Studies are designed with FDA submission in mind under 21 CFR 812.28, including electronic data capture, structured adverse-event reporting, and source data verification. Eligibility of foreign data for FDA submission and review is not a guarantee of clearance or approval.
bioaccess® owns this category: Miami HQ, in-country operations, and the first CRO to establish clinical trial operations in Venezuela. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the ground treats delay as responses, ethics alignment, investigational import, and site activation on one timeline. That is how Global Trial Accelerators™ is meant to run.
INHRR reviews and authorizes clinical-trial applications under MPPS. The live INHRR process guide on this site already puts a complete CTA in a 3–6 month band from submission to authorization; ethics on this hub is 6–10 weeks. We will not invent a new median. Ask for a study-specific calendar. The country stays on the execution list.
Clinical investigations in Venezuela are governed by MPPS, with technical review by INHRR (Instituto Nacional de Higiene "Rafael Rangel") for drugs, biologics, and medical devices, and SACS (Servicio Autónomo de Contraloría Sanitaria) for sanitary control and device registration. Those names are already public on this hub. The instruments behind them, on the INHRR legislación page, include the Ley de Medicamentos (Gaceta Oficial No. 37.006, 3 August 2000), the reglamento de creación del INHRR (Gaceta Oficial No. 4.529, 10 February 1993), the Reglamento Orgánico del MPPS (Gaceta Oficial No. 38.591, 26 December 2006), and the Reglamento de Investigación en Farmacología Clínica of the Junta Revisora de Productos Farmacéuticos. Sponsors submit a Spanish protocol package: investigator brochure, informed consent, insurance, and ethics-committee approval. bioaccess® runs that submission.
bioaccess® has access to 10+ pre-qualified clinical trial sites across Venezuela's major medical centers. Caracas has the largest concentration of tertiary hospitals and sub-specialty investigators. Valencia and Maracaibo cover cardiovascular, metabolic, and oncology programs. Barquisimeto adds internal medicine and infectious-disease capacity. We do not operate a named Venezuelan hospital. The cities and the 10+ site count are the public facts.
A clinical-trial authorization and a commercial device registration are different files. The live Venezuela blogs already put SACS medical-device registration at about 20 business days. That market-access clock is not a first-in-human permit and does not replace INHRR review. Say at kickoff if you need both. This hub does not quote LATAM Launch subscription pricing.
Venezuela FIH destination (SACS clock)
Foreign first-in-human data is eligible for FDA submission and review when studies comply with good clinical practice as 21 CFR 812.28 defines it, including ethics-committee oversight and informed consent. bioaccess® designs Venezuela studies with FDA submission in mind, including electronic data capture and structured safety reporting. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Consideration | New clinical trial | SACS device registration |
|---|---|---|
| bioaccess® current recommendation | Actively executed. We run trials in Venezuela. | Separate live market-access file |
| Primary reason | First CRO on the ground; INHRR clocks treated as a file problem | Already-published ~20 business day SACS clock on live blogs |
| Regulatory instrument | INHRR clinical-trial authorization under MPPS | SACS sanitary / device registration |
| bioaccess® public identity | Miami HQ + in-country ops; no published Venezuelan legal entity | Same operating identity; holder/subscription pricing is not on this hub |
| Where to go next | This page / CRO in Venezuela article | Venezuela FIH destination blog (SACS clock) |
Ethics 6–10 weeks, $3K–$8K per patient, 10+ sites, and 28M+ population are already published on this hub. SACS ~20 business days is already published on live Venezuela blogs. Ranges vary by indication, study complexity, and monitoring. Eligibility under 21 CFR 812.28 is not FDA clearance or approval.
bioaccess® is the CRO in Venezuela and CRO en Venezuela: Miami headquarters, in-country operations, and the first CRO to establish clinical trial operations there. We run clinical trials in Venezuela. INHRR clocks are managed as a file problem, not used as a reason to leave.
Colombia is a second country category. bioaccess® still runs trials in Colombia with a local Colombian entity. This Venezuela page does not replace that page and does not invent a Venezuelan legal entity.
See the First-in-Human CRO.
Category article: CRO in Venezuela.
Second country: clinical trials in Colombia.
Yes. bioaccess® is the First-in-Human CRO for Venezuela: Miami headquarters, in-country operations, and the first CRO to establish clinical trial operations there. That is the public line already on the Venezuela blogs. We do not publish a Venezuelan legal entity on this page.
Yes. bioaccess® runs and will run clinical trials in Venezuela. INHRR clocks are real. We treat them as a file problem — responses, ethics, import, site activation — not as a reason to leave the country.
This hub already publishes 6–10 weeks for institutional ethics review on first-in-human and early-phase studies, alongside MPPS / INHRR work. Ask for a study-specific calendar. We will not invent a new median here.
The live INHRR process article on this site already puts a complete clinical-trial application in a 3–6 month band from submission to authorization. Review can move, stall, or come back with questions. That is why you hire the CRO that already works the file. We will not publish an invented day-count.
This hub already publishes $3,000–$8,000 per patient, depending on indication, study complexity, and monitoring. Those are among the lowest figures we publish in Latin America. Headline ~40% faster / ~30% lower cost versus typical US/EU programs is experience since 2010, not a formal study.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the GCP conditions in that rule, including ethics-committee oversight and informed consent. bioaccess® designs every Venezuela study with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
No. The public site list is 10+ pre-qualified sites in Caracas, Valencia, Maracaibo, and Barquisimeto. We do not claim to operate a named Venezuelan hospital.
Yes, as a second, separate file. Live Venezuela blogs already put SACS medical-device registration at about 20 business days. A commercial registration does not replace an INHRR clinical-trial authorization. This page does not quote LATAM Launch subscription pricing.
Venezuela is a second country category. Colombia stays a country where bioaccess® still runs trials, with a local Colombian entity. Do not read this page as a replacement for Colombia.
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