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 Sírio-Libanês as a bioaccess® client.
If you searched Hospital Sirio-Libanes first-in-human, Hospital Sírio-Libanês São Paulo clinical trial, Sirio Libanes CRO, or “go direct Hospital Sírio-Libanês,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Sírio-Libanês in São Paulo, Brazil, is a real private hospital string on ClinicalTrials.gov. This page is the São Paulo campus family. It is not Brasília and not Buenos Aires. 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 São Paulo Sírio-Libanês intercept. São Paulo spelling variants merge onto this slug as NCT spellings of the same campus family — not as different hospitals we invent. We do not merge Brasília or Buenos Aires Sírio strings. Distinct from Hospital Israelita Albert Einstein (CMS 95621), Hospital do Coração (HCor) (CMS 95633), and ICESP (CMS 95642). Sharing São Paulo 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 leftover rows in /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.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). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.
- Hospital Sírio-Libanês (São Paulo, Brazil) — canonical NCT string: ALL interventional n=29; DEVICE n=1. Example NCT IDs: NCT01667419, NCT01686412, NCT02118584.
- Hospital Sírio Libanês (same SP campus family): ALL n=18.
- Hospital Sirio Libanes (same SP campus family): ALL n=17.
- Hospital Sirio-Libanes (same SP campus family): ALL n=8.
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes (same SP campus family): ALL n=22. Named as an NCT spelling of this São Paulo campus family. We do not invent that it is a different hospital.
List each n separately. We do not add 29+18+17+8+22 as a unique-study union. We do not merge Brasília or Buenos Aires Sírio strings onto this slug.
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 Sírio-Libanês clinical trial” or “Sirio Libanes São Paulo FIH” finds ALL n=29 (DEVICE n=1) and a stack of spelling aliases without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Einstein, HCor, ICESP, Brasília Sírio, or Buenos Aires Sírio. A private São Paulo hospital is still not a CRO. Spelling variants are not extra hospitals we invent.
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 at Sírio-Libanês in São Paulo is not an Einstein, HCor, or ICESP file, and it is not a Brasília or Buenos Aires Sírio 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
Hospital Sírio-Libanês in São Paulo is a serious private hospital. ALL n=29 (DEVICE n=1) on the canonical string, and the listed spelling-variant n values, are registry volume, not a punchline. Do not add the aliases. Do not invent that they are different hospitals. Do not merge Brasília or Buenos Aires Sírio strings. Do not merge Einstein, HCor, or ICESP. Use the São Paulo 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 Hospital Sírio-Libanês 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 Einstein, HCor, ICESP, or a Brasília / Buenos Aires Sírio campus?
No. Einstein is CMS 95621. HCor is CMS 95633. ICESP is CMS 95642. Brasília and Buenos Aires Sírio strings are other cities and are not merged here. This page is the São Paulo Hospital Sírio-Libanês campus family only. The Sociedade Beneficente spelling is an NCT string for this family, not a second hospital we invent.
Why so many ALL n values on one page?
ClinicalTrials.gov stored several São Paulo spellings of one campus family. We list each n. We do not publish a union. We do not invent that they are different hospitals.
Is n=29 plus n=18 plus n=17 plus n=8 plus n=22 a unique-study total?
We will not claim that. Overlap between spelling rows is expected. We list each n. We do not publish a union.
Is this the Brasília or Buenos Aires Sírio campus?
No. Those strings are other cities. This page is São Paulo only.
Does DEVICE n=1 mean this hospital already owns ANVISA for a new device FIH?
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. A DEVICE n of 1 is a registry token, not a dossier.
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 sibling (do not merge): Einstein.
Julio G. Martinez-Clark, CEO · bioaccess®