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 UNESP Faculdade de Medicina Campus Botucatu as a bioaccess® client.
If you searched UNESP Botucatu first-in-human, Faculdade de Medicina de Botucatu clinical trial, UNESP CRO Brazil, or “go direct UNESP Faculdade de Medicina Campus Botucatu,” you followed a campus string ClinicalTrials.gov still publishes. UNESP – Faculdade de Medicina da Universidade Estadual Paulista – Campus Botucatu is a real named medical-school campus 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 campus 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 campus still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Botucatu medical-school campus. It is not University of São Paulo, not UNIFESP, and not University of Campinas / UNICAMP. Sharing a São Paulo-state university search is not a license to collapse them. Botucatu is not São Paulo city and is not Campinas. Aliases Faculdade de Medicina de Botucatu – UNESP and Faculdade de Medicina da UNESP stay on this page; we do not ship second pages. UNESP Presidente Prudente or Araraquara strings are other campuses, not this row and not a second page.
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.
- UNESP – Faculdade de Medicina da Universidade Estadual Paulista – Campus Botucatu (Botucatu, Brazil) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT02100696, NCT02118584, NCT02163759.
- Alias Faculdade de Medicina de Botucatu – UNESP: ALL n=8. Listed separately. Same page. No combined total.
- Alias Faculdade de Medicina da UNESP: ALL n=8. Listed separately. Same page. No combined total.
Alias counts are listed separately. The 22+8+8 counts are not added together. We will not invent a DEVICE n.
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 campus as a client site.
That is the leak: a founder searching “UNESP Botucatu first-in-human” or “Faculdade de Medicina de Botucatu clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on USP, UNIFESP, or UNICAMP. A named medical-school campus is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named campus 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 campus 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 campus 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 UNESP Botucatu is not a USP file, not a UNIFESP file, and not a UNICAMP 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 campus
UNESP Faculdade de Medicina Campus Botucatu is a serious named Botucatu medical-school campus on the public registry. ALL n=22 is registry volume, not a punchline. It is separate from USP, UNIFESP, or UNICAMP. 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. In Panama and Colombia alike, ethics timing depends 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 UNESP Faculdade de Medicina Campus Botucatu directly for a device FIH?
You can try. The campus 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 campus. We will not invent that claim. This page answers the search; it does not claim the studies.
Is this the same page as USP, UNIFESP, or UNICAMP?
No. USP has its own page. UNIFESP has its own page. UNICAMP has its own page. This page is UNESP Faculdade de Medicina Campus Botucatu only. Alias ALL n=8 and ALL n=8 stay listed separately; we do not combine them. Other UNESP cities are not this row and not a second page.
Should I add canonical ALL n=22 and the two ALL n=8 aliases?
No. Alias n is listed separately. A combined unique-study total is not published. Those Faculdade de Medicina strings stay on this page.
Is this USP, UNIFESP, or UNICAMP?
No. Those are already-live university pages. Botucatu is a different campus and a different NCT string.
Why DEVICE n=0?
That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 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 NCT02100696?
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. University siblings (do not merge): University of São Paulo, UNIFESP, University of Campinas.
Julio G. Martinez-Clark, CEO · bioaccess®