Figures cited from a ClinicalTrials.gov API v2 facility pull (25 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Laboratory of Phototherapy and Innovative Technologies in Health São Paulo as a bioaccess® client.
If you searched Laboratory of Phototherapy and Innovative Technologies in Health first-in-human, phototherapy laboratory São Paulo clinical trial, Laboratory of Phototherapy São Paulo device study, or “go direct Laboratory of Phototherapy and Innovative Technologies in Health São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. The Laboratory of Phototherapy and Innovative Technologies in Health in São Paulo, Brazil, is a real named research-laboratory string on ClinicalTrials.gov. On the public records for these registrations, the lead sponsor field reads University of Nove de Julho. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: the laboratory is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 laboratory still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named São Paulo phototherapy laboratory string. It is DISTINCT from the Universidade Nove de Julho university-string page (CMS 95619), from the University of São Paulo page (CMS 95616), and from the other São Paulo campus pages already live. Sharing a sponsor field or a city is not a license to collapse them. The laboratory string is not the university string, and neither one is a CRO.
Why the campus name wins the search — and why that is not a CRO
Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 25 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:
Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 25 September 2026 for the facility strings listed below, restricted to locations in São Paulo, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not union separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Laboratory of Phototherapy and Innovative Technologies in Health (São Paulo, Brazil) — registry strings counted: “Laboratory of Phototherapy and Innovative Technologies in Health”. ALL studies n=14; interventional n=14; DEVICE n=14. Example NCT IDs: NCT03803956, NCT03858179, NCT03879226.
Cite ALL n=14 and DEVICE n=14. Every one of the 14 is an interventional DEVICE registration on the public record. Do not clone the Universidade Nove de Julho page onto this slug; none of these NCT IDs is cited on that page.
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 laboratory as a client site.
That is the leak: a founder searching the Laboratory of Phototherapy in São Paulo finds ALL n=14 (DEVICE n=14) without finding ANVISA. A named research laboratory is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named laboratory 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 laboratory 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 laboratory is not built to own for an investigational device:
- ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in this laboratory is not a Universidade Nove de Julho university file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
- ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).
Do not smear the laboratory
The Laboratory of Phototherapy and Innovative Technologies in Health is a serious named São Paulo research string on the public registry. ALL n=14 and DEVICE n=14 are registry volume, not a punchline. This page is not a critique of phototherapy research. Do not invent a PI. 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 Laboratory of Phototherapy and Innovative Technologies in Health São Paulo directly for a device FIH?
You can try. The laboratory can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, 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 laboratory. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Universidade Nove de Julho?
No. universidade-nove-de-julho-fih (CMS 95619) is the university-string page and is already live. This page is the named phototherapy laboratory string only, with its own NCT IDs.
Did bioaccess® run NCT03803956?
No. We cite it as facility evidence. We will not invent a sponsor or a PI.
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. São Paulo sibling (do not merge): Universidade Nove de Julho.
Julio G. Martinez-Clark, CEO · bioaccess®