Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim IBPClin as a bioaccess® client.
If you searched IBPClin first-in-human, Instituto Brasil de Pesquisa Clínica clinical trial, IBPClin Rio CRO, or “go direct IBPClin,” you followed a campus string ClinicalTrials.gov still publishes. IBPClin — Instituto Brasil de Pesquisa Clínica in Rio de Janeiro, Brazil, is a real named investigative-institute string on ClinicalTrials.gov. This is the first Rio de Janeiro clinic slug in this intercept series. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANVISA/CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Rio investigative institute. It is not CEPIC (CMS 95662), not CPQuali (CMS 95671), not CPCLIN (CMS 95684), and not CEMEC (CMS 95695). It is not Universidade Federal do Rio de Janeiro (this batch, a university string on a different slug). Sharing a Rio de Janeiro search or sharing a “pesquisa clínica” token is not a license to collapse them.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:
Counts come from /workspace/five-trials/kill-page-batch-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- IBPClin – Instituto Brasil de Pesquisa Clínica (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT03899259, NCT03952559, NCT04255433.
Cite canonical ALL n=25 and DEVICE n=0. We will not invent an alias union with UFRJ. We will not invent a DEVICE n. First Rio clinic slug; UFRJ stays on its own slug in this batch.
Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.
We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this institute as a client site.
That is the leak: a founder searching “IBPClin Rio first-in-human” or “Instituto Brasil de Pesquisa Clínica clinical trial” finds canonical ALL n=25 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. A named research institute is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named institute can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.
What the institute can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing service line.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the institute is not built to own for an investigational device:
- ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at IBPClin is not a CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ file.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a campus-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
- Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.
Going direct to this campus is how you confirm a room. It is not how you open an investigational file.
How ANVISA actually works (the short version)
Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.
Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.
All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Do not smear the institute
IBPClin is a serious named Rio investigative institute on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. Do not invent a PI. Use the site when the protocol fits. Hire the operator.
What the CRO still does after you have the campus on a slide
- Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.
The firm was founded in 2010. That is the operator layer around a campus string.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract IBPClin directly for a device FIH?
You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® run the NCT IDs listed here?
No public bioaccess® case-study page names this institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as CEPIC, CPQuali, CPCLIN, CEMEC, or Universidade Federal do Rio de Janeiro?
No. CEPIC is CMS 95662. CPQuali is CMS 95671. CPCLIN is CMS 95684. CEMEC is CMS 95695. UFRJ is a different Rio university string in this batch. This page is IBPClin only. First Rio clinic slug.
Is this UFRJ?
No. Universidade Federal do Rio de Janeiro is a university NCT string on its own slug in this batch. IBPClin is a named investigative institute. Rio is not a merge key.
Is this CEPIC, CPQuali, CPCLIN, or CEMEC?
No. Those are already-live research-center intercepts in other Brazilian cities. This page is IBPClin, Rio de Janeiro.
Why DEVICE n=0?
That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=25 is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.
Did bioaccess® run NCT03899259?
No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.
Next step
If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. São Paulo research-center sibling (do not merge): CPCLIN.
Julio G. Martinez-Clark, CEO · bioaccess®