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 Hospital Bruno Born as a bioaccess® client.
If you searched Hospital Bruno Born first-in-human, Bruno Born Lajeado clinical trial, Hospital Bruno Born CRO, or “go direct Hospital Bruno Born,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Bruno Born in Lajeado, Rio Grande do Sul, Brazil, is a real hospital string on ClinicalTrials.gov. Lajeado is not Porto Alegre. 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 hospital 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.
This is the Lajeado campus page. Distinct from Hospital de Clínicas de Porto Alegre, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Hospital Moinhos de Vento, Hospital Mãe de Deus (separate page), UFCSPA (separate page), Hospital Ernesto Dornelles, Hospital Nossa Senhora da Conceição, and Hospital São Lucas da PUCRS. Lajeado is a different city. Sharing Rio Grande do Sul is not a license to collapse every hospital into Porto Alegre.
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), this campus sits here after filters:
Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.
- Hospital Bruno Born (Lajeado, Brazil): ALL interventional n=31; DEVICE n=0 on the ranking table. Example NCT IDs: NCT01897532, NCT02178956, NCT02272413.
We will not invent a DEVICE ranking from the top-40 CSV. We will not borrow a Porto Alegre count onto Lajeado.
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 hospital as a client site.
That is the leak: a founder searching “Hospital Bruno Born clinical trial” or “Lajeado FIH” finds ALL n=31 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS. Lajeado is still not Porto Alegre. An NCT city field is not a license to collapse every Rio Grande do Sul hospital.
The site is the site. The CRO is the operator.
A named hospital 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 hospital 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 hospital 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 in Lajeado is not a Porto Alegre 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 in 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.
Not a critique of the hospital
Hospital Bruno Born is a serious Lajeado resource. ALL n=31 is registry volume, not a punchline. It is separate from HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS. Do not treat every Rio Grande do Sul string as one CEP. 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract Hospital Bruno Born directly for a device FIH?
You can try. The hospital 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 hospital. We will not invent that claim. This page answers the search; it does not claim the studies.
Is this the same page as HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS?
No. HCPA has its own page. Santa Casa Porto Alegre has its own page. Moinhos has its own page. Mãe de Deus has its own page (Porto Alegre). UFCSPA has its own page. Dornelles has its own page. Conceição has its own page. São Lucas PUCRS has its own page. This page is Hospital Bruno Born, Lajeado only.
Is Lajeado the same metro as Porto Alegre?
No. Lajeado is a different city in Rio Grande do Sul. Sharing a state is not a license to collapse the hospital into HCPA, Santa Casa, Moinhos, or Mãe de Deus.
Does ALL n=31 mean this campus already owns ANVISA?
No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub.
Why DEVICE n=0?
That is the ranking-table DEVICE count for this string. We will not invent a DEVICE n.
Is this the same page as Hospital Mãe de Deus?
No. Mãe de Deus is Porto Alegre (separate page). Bruno Born is Lajeado. Different city. Different NCT string.
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. Porto Alegre sibling (do not merge): HCPA.
Julio G. Martinez-Clark, CEO · bioaccess®