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 merged facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Nove de Julho as a bioaccess® client.
If you searched Universidade Nove de Julho first-in-human, University of Nove de Julho CRO, Nove de Julho University clinical trials, or “go direct UNINOVE São Paulo,” you followed campus strings ClinicalTrials.gov still publishes as three separate labels. They are one university. They are not a first-in-human medical-device CRO, and they are 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 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 merges three accent/language aliases into one slug: Universidade Nove de Julho, University of Nove de Julho, and Nove de Julho University. It does not clone InCor HCFMUSP or Dante Pazzanese. Those are different São Paulo buildings.
Why the three spellings win the search — and why that is not a CRO
ClinicalTrials.gov stores Portuguese and English campus names as separate facility keys. On the 1 September 2026 LATAM DEVICE sweep they sit as:
- Universidade Nove de Julho: DEVICE rank 9, n=11. Example NCT IDs: NCT02588768, NCT02591680, NCT02715050.
- University of Nove de Julho: DEVICE rank 14, n=9. Example NCT IDs: NCT01984021, NCT02057120, NCT02398344.
- Nove de Julho University: DEVICE rank 27, n=6. Example NCT IDs: NCT01844271, NCT02474602, NCT02498249.
Public snapshots of those IDs list lead sponsor University of Nove de Julho (or the Portuguese equivalent) and the matching location string. Brief titles cluster around photobiomodulation / phototherapy, low-level laser, kinesio taping, acupuncture on trapezius, neuromuscular stimulus, and tDCS in hemiparesis. 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 university as a client site. Combined DEVICE n=11+9+6 is how a sponsor searching any of the three spellings finds a campus without finding an operator.
The site is the site. The CRO is the operator.
A São Paulo private university can provide labs, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under three English/Portuguese spellings. 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.
- 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). Three NCT spellings do not become 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 UNINOVE-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, Recife, or Porto Alegre, a single-university MSA will not stretch.
Going direct to Universidade Nove de Julho is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Nove de Julho (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Labs, rooms, 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 São Paulo university (three NCT spellings) | 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.
Do not smear the university — and do not merge São Paulo buildings
Universidade Nove de Julho is a serious academic resource. Combined DEVICE volume across three spellings is a signal of how the registry indexes the same campus, not a punchline. This page is not a critique of phototherapy or rehabilitation listings. Volume is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.
Do not merge this campus into InCor HCFMUSP, Dante Pazzanese, or the University of Sao Paulo NCT-string page. Different queries. Different buildings.
What the CRO still does after you have a UNINOVE slide
- Regulatory-fit, not tourism. Brazil is a sourced device geography. Three NCT aliases of one private university are 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 Nove de Julho only if it fits the protocol.
- 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 Universidade Nove de Julho directly for a device FIH?
You can try. The university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing under three NCT spellings (n=11+9+6 DEVICE), 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.
Why merge three names onto one page?
Because they are accent and language aliases of one campus. ClinicalTrials.gov counted them separately. Sponsors search all three. One slug. We do not invent a fourth hospital.
Did bioaccess® run these NCT IDs?
No public bioaccess® case-study page says so. We will not invent that claim.
Next step
If the search that brought you here was Universidade Nove de Julho, University of Nove de Julho, or Nove de Julho University, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Sibling São Paulo NCT string: University of Sao Paulo.
Julio G. Martinez-Clark, CEO · bioaccess®