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 Santa Casa de Belo Horizonte as a bioaccess® client.
If you searched Santa Casa Belo Horizonte first-in-human, Santa Casa de Misericordia de Belo Horizonte clinical trial, Santa Casa BH CRO, or “go direct Santa Casa de Belo Horizonte,” you followed a campus string ClinicalTrials.gov still publishes. Santa Casa de Misericórdia de Belo Horizonte in Belo Horizonte, Minas Gerais, Brazil, is a real hospital string on ClinicalTrials.gov. 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 page is the Belo Horizonte Santa Casa intercept. Distinct from Irmandade da Santa Casa de Misericórdia de Porto Alegre (CMS 95651). That is a different city, a different state (Rio Grande do Sul vs Minas Gerais), and a different NCT string family. Sharing the words “Santa Casa” is not a license to collapse them. This page is not a Porto Alegre clone.
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-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.
- Santa Casa de Misericordia de Belo Horizonte (Belo Horizonte, Brazil): ALL interventional n=38; DEVICE n=0 on the picks file. Batch-5 pick #2. Example NCT IDs: NCT00071331, NCT00412893, NCT00413218.
Cite ALL n=38 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not borrow a Porto Alegre Santa Casa count onto this campus.
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 “Santa Casa Belo Horizonte clinical trial” finds ALL n=38 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Santa Casa Porto Alegre. Minas Gerais is not Rio Grande do Sul. An NCT city field is not a license to collapse every Santa Casa.
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 Belo Horizonte is not a Porto Alegre Santa Casa 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 hospital
Santa Casa de Belo Horizonte is a serious Minas Gerais resource. ALL n=38 is registry volume, not a punchline. Do not merge it into Santa Casa Porto Alegre (CMS 95651). Do not smear that campus by treating every Santa Casa string as one ANVISA file. 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 Santa Casa de Belo Horizonte 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 intercepts the search; it does not claim the studies.
Is this the same page as Santa Casa de Porto Alegre?
No. Irmandade da Santa Casa de Misericórdia de Porto Alegre is CMS 95651. Different city. Minas Gerais vs Rio Grande do Sul. This page is Santa Casa de Misericórdia de Belo Horizonte only.
Is Belo Horizonte the same metro as Porto Alegre?
No. Porto Alegre is Rio Grande do Sul. Belo Horizonte is Minas Gerais. Sharing a hospital-order name does not make them one CEP or one ANVISA file.
Does ALL n=38 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 picks-file DEVICE count for this string. We will not invent a DEVICE n from the CSV top-40 dump.
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 Santa Casa sibling (do not merge): Santa Casa Porto Alegre.
Julio G. Martinez-Clark, CEO · bioaccess®