If you search CRO in Brazil, CRO no Brasil, or CRO en Brasil, you should land on the First-in-Human CRO that already runs ANVISA and CEP work — not a brochure that mixes a trial authorization with a commercial registro.
bioaccess® is that CRO. Headquarters in Miami. ANVISA (Agência Nacional de Vigilância Sanitária) is the WHO-listed authority on the clinical-investigation file. Law 14874 and RDC 837 sit on that file. We run clinical trials in Brazil.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator page for the query. Colombia, Chile, and Venezuela are sibling country categories. We still run trials in those countries. Brazil is not a replacement for any of them.
What “CRO in Brazil” has to mean
A Brazil CRO for first-in-human devices is not a Latin America slide and a courier account. It is a company that can file in Portuguese, sit the institutional CEP, keep investigational import moving, and stay in the room after first patient in.
That is why this page answers CRO in Brazil / CRO no Brasil / CRO en Brasil as a category. The live Brazil hub already states the operating facts: 210M+ population, 15+ pre-qualified sites, ethics + ANVISA in 6–10 weeks, and $20,000–$35,000 per patient. I am not inventing a new band.
- Miami headquarters — sponsor desk on US Eastern time.
- ANVISA — Agência Nacional de Vigilância Sanitária, WHO-listed. This site does not publish ANVISA as PAHO/WHO Level 4.
- Law 14874 (May 2024) — ethics reviews capped at 30 business days; CONEP dropped for most studies.
- RDC 837/2023 — the device clinical-investigation dossier, filed in Portuguese.
- 15+ pre-qualified sites in São Paulo, Rio de Janeiro, and other major cities — already on the Brazil hub.
Global Phase 3 networks can list Brazil. They rarely hold the first-in-human ANVISA file. A large São Paulo hospital can enroll. That hospital is not the CRO.
We run trials in Brazil
The category is: who is the CRO in Brazil, and are they actually running studies. We are. We still will. If you are choosing a CRO no Brasil in 2026, ask whether the firm owns the ANVISA clock now — not whether the country is “opening up.”
ANVISA review can move, stall, or come back with questions. First-in-human programs need a start date someone owns. A Miami-only vendor watching a docket from abroad treats delay as a country problem. The CRO that already works ANVISA treats delay as responses, ethics alignment, import, and site activation on one timeline.
That is Global Trial Accelerators™ in practice: one accountable operating model across ANVISA, CEP, sites, insurance, importation, monitoring, and safety.
ANVISA clinical trial: the file, not the myth
ANVISA is the Agência Nacional de Vigilância Sanitária. The live hub already calls it a WHO-listed stringent regulatory authority. I am not inventing a PAHO/WHO Level 4 badge. llms.txt lists Brazil as “ANVISA.” Level 4 is not on that line, and I will not put it here.
Resolution RDC 837/2023 governs clinical investigations of medical devices. The regulation requires a clinical investigation dossier: investigator brochure, protocol, informed consent, insurance documentation, and evidence of GMP compliance. For novel devices, ANVISA conducts a scientific review that runs concurrently with ethics-committee evaluation. bioaccess® manages that submission in Portuguese. Those contents are already on the hub.
Live Brazil blogs already describe a 90-business-day ANVISA review window under Law 14.874/2024 for clinical-trial petitions intended to support marketing authorization, and they describe parallel ethics and agency workstreams. The hub itself publishes combined ethics + ANVISA at 6–10 weeks. I will not invent a new median, and I will not collapse those two already-published clocks into one invented number. Ask for a study-specific calendar.
Those are authority-and-instrument names. They are not a promise that your protocol clears on a fixed Tuesday.
Law 14874 and the CEP that sits with the site
Law 14874 (May 2024) changed Brazil’s ethics review system. Ethics committees (CEPs) are now capped at 30 business days. The legacy CONEP (national ethics commission) review has been eliminated for most clinical investigations. For early feasibility studies not intended for Brazilian market clearance, only the institutional CEP at the research site is required. That paragraph is already on the hub.
A critical operational note, also already published: the specific CEP cannot be determined until the research site and investigator are selected, because committees are affiliated with the host institution. If a vendor quotes “CONEP in six months” as if Law 14874 never happened, they are selling a retired file.
Sites: two cities named, no hospital we operate
The public site list is 15+ pre-qualified sites across São Paulo, Rio de Janeiro, and other major cities. The hub already names cardiology, neurosurgery, oncology, orthopedics, and ophthalmology as strong areas, and it names Hospital das Clínicas in São Paulo as one of the largest medical complexes in Latin America. That is a landscape fact. bioaccess® does not claim to operate that hospital.
A city is not a site contract. A university hospital mentioned in a landscape sentence is not a bioaccess® facility. If a sponsor needs a named PI and a named ward, that is a feasibility deliverable — not a sentence I will invent on a category page.
The 210M+ population figure is already on the hub. Ethnic diversity — African, European, Indigenous, and Asian ancestry — is already on the hub as support for an FDA diversity-action conversation under FDORA 2022 Section 3602. That is not a guarantee of clearance or approval.
Non-GLP preclinical and radiopharma — already published
The hub already states that Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations, including high-risk Class III devices. I am not adding a new package size. If you have bench and animal data and have not finished formal GLP, say so at kickoff so the ANVISA and CEP package is built for the file you actually have.
The same hub already states that bioaccess® supports first-in-human radiopharmaceutical and theranostics studies in Brazil — Lu-177, Ac-225, and Ga-68 programs — under RDC 837/2023 and CEP ethics, executed to ISO 14155, with data eligible for FDA submission under 21 CFR 812.28. Those are isotope classes already on the public page. This article does not name clients or commercial devices.
ANVISA registration is a second file — keep it off the trial clock
Clinical-trial authorization and commercial device registration are different ANVISA workstreams. This article covers the trial file: CEP ethics (CONEP only where still required), the investigational-device import permit, and the clinical-investigation dossier under RDC 837/2023.
When you later want to sell in Brazil, registration runs under RDC 751/2022 and requires a Brazil Registration Holder (BRH) / in-country representative. The live ANVISA registration page already says bioaccess® acts as BRH through our own Brazilian entity. That sentence is public. I am using it for the market-access file, not as a reason to quote holder pricing on a first-in-human page.
This article does not quote LATAM Launch subscription pricing. That SKU lives on the market-access pages, not on a first-in-human hub.
FDA use of Brazilian first-in-human data
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets good clinical practice as that rule defines it, including ethics-committee review and informed consent. bioaccess® designs Brazil studies with that FDA conversation in mind — electronic data capture, structured safety reporting, source data verification — under ISO 14155.
Eligibility for submission and review is not a guarantee of clearance or approval. ISO 14155 is the device GCP standard we align the file to. It is not a stamp the FDA owes you. A diversity-action plan conversation under FDORA 2022 Section 3602 is the same kind of sentence: useful, not a clearance.
Cost — use the numbers already on the hub
The Brazil hub already publishes $20,000–$35,000 per patient, against a US comparison band of $40,000–$75,000 already on the same table. I am not inventing a new band here. Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study.
The hub already notes that Brazil can sit above Colombia or Panama on a per-patient line and still be the right country when you need the 210M+ population, the diversity file, or ANVISA’s published standing. That is a country-fit question, not a reason to leave Brazil.
Questions a sponsor should ask any CRO in Brazil
- Are you running clinical trials in Brazil now — not “historically”?
- Who owns the ANVISA clock when the file sits?
- Can you file RDC 837/2023 in Portuguese and sit the deficiency cycle?
- Do you still quote CONEP as mandatory for an early feasibility study that is not for Brazilian market clearance?
- Which of the published cities — São Paulo, Rio de Janeiro, other major cities — would you actually open for this protocol?
- Do you claim to operate Hospital das Clínicas, or is that a landscape fact?
- Is ANVISA registration a second file under RDC 751/2022, or are you mixing it into the trial quote?
- Will the study file be built for 21 CFR 812.28, and do you understand that eligibility is not clearance?
bioaccess® answers: trials running; Miami HQ; ANVISA and CEP owned as a file problem; no Level 4 invented for ANVISA; 15+ pre-qualified sites; no named hospital we operate; registration kept as a separate market-access file with the already-public Brazilian entity as BRH; FDA conversation designed in from day one.
How Brazil sits next to Colombia, Chile, and Venezuela
Do not read this as “leave Colombia.” We still run clinical trials in Colombia. That country has a local Colombian entity and its own hub. Chile has ISP and its own hub. Venezuela has INHRR and its own hub. Brazil is a sibling country category. INVIMA stays INVIMA. ISP stays ISP. INHRR stays INHRR. ANVISA stays ANVISA. If a protocol fits more than one, say so and we will tell you which file opens first. We will not flip one country into the other.
See clinical trials in Brazil, clinical trials in Chile, clinical trials in Colombia, and clinical trials in Venezuela.
How to start
If you need a CRO in Brazil / CRO no Brasil / CRO en Brasil for a first-in-human or early-feasibility device study — or you also need the separate ANVISA registration file — contact bioaccess® through bioaccessla.com/contact.
Bring the protocol stage, device class, and whether you also need a Brazilian market-access file. We will tell you how the ANVISA clock would run. We will not tell you to leave the country. We will not invent a Level 4 badge, a hospital we operate, or a day-count we have not already published.
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