Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the NCT facility string “University of Sao Paulo” and example NCT IDs those sources support. We do not invent InCor, HCFMUSP, or a principal investigator on this page. We do not claim University of Sao Paulo as a bioaccess® client.
If you searched University of Sao Paulo first-in-human, University of Sao Paulo CRO, USP clinical trials Brazil device, or “go direct University of Sao Paulo,” you followed the exact location string ClinicalTrials.gov still publishes. University of Sao Paulo is a real university. 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 string is the site label. 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 São Paulo is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.
This page answers the registry string University of Sao Paulo only. It does not invent InCor or HCFMUSP as this page’s campus. Heart-institute searches already have a live intercept: InCor HCFMUSP (CMS 95522). Link that page. Do not clone it. “University of Sao Paulo General Hospital” is a different NCT string (DEVICE n=7 on the same sweep) and is not merged here.
Why the NCT string wins the search — and why that is not a CRO
Sponsors type what the registry prints. On the 1 September 2026 ClinicalTrials.gov LATAM sweep, the facility string University of Sao Paulo, São Paulo, Brazil, is DEVICE rank 5, n=15, and ALL interventional rank 6, n=73. Example DEVICE NCT IDs: NCT01033084, NCT01149213, NCT01525524.
Public snapshots of those three IDs list lead sponsor University of Sao Paulo and location facility University of Sao Paulo. Brief titles on those records are transcranial direct current stimulation studies in major depressive disorder, including post-stroke depression. We cite the IDs as facility evidence. We will not invent a PI. We will not claim they are first-in-human device programs bioaccess® ran. We will not stretch them into a heart-institute claim. No live bioaccess® case-study page names this NCT string as a client site.
That is the leak: a founder searching “University of Sao Paulo clinical trial” or “USP FIH Brazil” finds a campus without finding ANVISA, import, insurance, or 21 CFR 812.28. Ranking n=15 device studies is registry volume, not a CRO product.
The site is the site. The CRO is the operator.
A São Paulo university campus can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under this English facility string. 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 university can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing lab or clinic.
- Share institutional CEP calendars and university research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the university is not built to own for an investigational device:
- ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese). A campus email is not that dossier.
- CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
- Investigational import — a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a USP-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
- The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
- Multi-country optionality. If São Paulo enrollment or the indication later needs Colombia, Panama, or another campus, a single-university MSA will not stretch.
Going direct to the University of Sao Paulo NCT string is how you confirm a label. It is not how you open an investigational file.
Site versus CRO
| Workstream | What the USP campus string (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, labs, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Institutional CEP calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not the permit holder by appearing on an NCT | ANVISA clinical-investigation dossier (RDC 837/2023) |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | University quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One NCT spelling in São Paulo | Colombia (INVIMA) and the rest of the bioaccess® platform |
How ANVISA and CEP actually work (the short version)
Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:
- Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
- Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
- Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
- For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
- Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
- Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.
All bioaccess® Brazil device protocols 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.
Sibling heart-institute page — do not merge it here
If the search you actually meant was Instituto do Coração / HCFMUSP / InCor, stay on incor-hcfmosp-fih. That page already covers public device rows such as Cephea and Leaflex under InCor spellings. This page will not copy those claims onto “University of Sao Paulo.” The Brazil country page already notes that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America as a landscape fact; bioaccess® does not claim to operate that hospital. Dante Pazzanese remains a separate intercept. Do not smear the university.
What the CRO still does after you have a USP slide
- Regulatory-fit, not tourism. Brazil is a sourced device geography. An English NCT campus string 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/CEP packet.
- Importer of record and device accountability.
- Site activation that is more than a tour. Activate a University of Sao Paulo site only if it fits the protocol — and only the building the protocol actually needs, not a merged InCor identity.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — 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 University of Sao Paulo directly for a device FIH?
You can try. A university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing as n=15 DEVICE / n=73 ALL 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.
Is this the InCor page?
No. InCor / HCFMUSP is already live at incor-hcfmosp-fih. This page is the NCT string “University of Sao Paulo” only.
Did bioaccess® run NCT01033084, NCT01149213, or NCT01525524?
No public bioaccess® case-study page says so. We will not invent that claim.
Next step
If the search that brought you here was University of Sao Paulo, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Heart-institute sibling: InCor HCFMUSP.
Julio G. Martinez-Clark, CEO · bioaccess®