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 Centro de Pesquisa São Lucas Campinas as a bioaccess® client.
If you searched Centro de Pesquisa Sao Lucas first-in-human, São Lucas Campinas clinical trial, Centro de Pesquisa São Lucas CRO Brazil, or “go direct Centro de Pesquisa São Lucas Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Pesquisa Sao Lucas in Campinas, Brazil, is a real named research-center string on ClinicalTrials.gov. Campinas is not Porto Alegre. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.
This page is the Campinas named research center. Distinct from Hospital São Lucas da PUCRS (CMS 95636, Porto Alegre). It is also not Hospital São Vicente de Paulo in Passo Fundo (this batch). Sharing “São Lucas” in another city is not a license to collapse them. Campinas versus Porto Alegre is the whole point of the intercept.
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-7-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; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Centro de Pesquisa Sao Lucas (Campinas, Brazil) — leftover ranking row / canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT03899259, NCT04211337, NCT04232553. JSONL confirm (1 September 2026 all_interventional dump, 17497 studies): unique NCT IDs on this Campinas string n=27.
- Accented alias Centro de Pesquisa São Lucas (Campinas): ALL n=4. Listed separately. Same slug. We do not invent a unique-study union of 27+4. We do not ship a second slug for the accented spelling.
Cite leftover ALL n=27 and DEVICE n=0 on the canonical string. Cite alias ALL n=4 separately. Do not add them. 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 center as a client site.
That is the leak: a founder searching “Centro de Pesquisa São Lucas Campinas clinical trial” or “São Lucas FIH Brazil” finds leftover ALL n=27 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital São Lucas da PUCRS in Porto Alegre. Campinas is still not Porto Alegre. A named research center is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named center 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 center 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 center 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 in Campinas is not a PUCRS São Lucas Porto Alegre 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 center
Centro de Pesquisa Sao Lucas in Campinas is a serious named research center on the public registry. ALL n=27 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Hospital São Lucas da PUCRS (Porto Alegre) or into Hospital São Vicente de Paulo (Passo Fundo). 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-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 Centro de Pesquisa São Lucas Campinas directly for a device FIH?
You can try. The center 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 center. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Hospital São Lucas da PUCRS or Hospital São Vicente de Paulo Passo Fundo?
No. Hospital São Lucas da PUCRS is CMS 95636 in Porto Alegre. Hospital São Vicente de Paulo is a Passo Fundo slug in this batch. This page is Centro de Pesquisa Sao Lucas, Campinas only. The accented alias ALL n=4 stays listed separately; we do not union.
Should I add leftover ALL n=27 and the accented ALL n=4?
No. Alias n is listed separately. A unique-study union is not published. The accented spelling is the same Campinas campus on the same slug.
Is this Hospital São Lucas da PUCRS?
No. PUCRS São Lucas is Porto Alegre (CMS 95636). This page is Campinas. City is the filter.
Why DEVICE n=0?
That is the leftover-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANVISA authorization.
Did bioaccess® run NCT03899259?
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. Porto Alegre sibling (do not merge): Hospital São Lucas da PUCRS.
Julio G. Martinez-Clark, CEO · bioaccess®