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 Hospital São Lucas da PUCRS as a bioaccess® client.
If you searched Hospital Sao Lucas PUCRS first-in-human, Hospital São Lucas da PUCRS clinical trial, São Lucas Porto Alegre CRO, or “go direct Hospital São Lucas da PUCRS,” you followed a campus string ClinicalTrials.gov still publishes. Hospital São Lucas da PUCRS in Porto Alegre is a real university hospital. ClinicalTrials.gov stores more than one spelling. 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 hospital 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.
This page is one intercept for two ALL spellings of the same campus. It does not clone Hospital de Clínicas de Porto Alegre (CMS 95615), Fundação Universitaria de Cardiologia (CMS 95612), or Hospital Moinhos de Vento (CMS 95622). Three (plus) Porto Alegre buildings. Three (plus) queries. List both strings; do not add the n’s as unique studies.
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:
- ALL: Hospital Sao Lucas – PUCRS (Porto Alegre, Brazil): n=56 (rank 14). Example NCT IDs: NCT00080340, NCT00413218, NCT00430352.
- ALL: Hospital São Lucas da PUCRS: n=56 (rank 15). Example NCT IDs: NCT00428220, NCT00430716, NCT00752362.
Two strings. Two ranks. Do not publish n=112 as if they were unique studies.
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 hospital as a client site.
That is the leak: a founder searching “São Lucas PUCRS clinical trial” finds two ALL spellings of one Porto Alegre campus without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, FUC, or Moinhos.
The site is the site. The CRO is the operator.
A named hospital 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 hospital 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 hospital is not built to own for an investigational device:
- ANVISA. Device investigations sit under RDC 837/2023. A hallway conversation at São Lucas is not that dossier, and it is not an HCPA 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.
Site versus CRO
| Workstream | What São Lucas PUCRS (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, caseload, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not the permit holder by appearing on an NCT | ANVISA clinical-investigation file |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital or 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 | Two NCT spellings of one Porto Alegre campus; not HCPA, FUC, or Moinhos | 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 hospital
Hospital São Lucas da PUCRS is a serious academic resource. n=56 on each spelling is registry volume, not a punchline and not a unique-n total of 112. Do not merge Porto Alegre buildings. 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 Hospital São Lucas da PUCRS directly for a device FIH?
You can try. The hospital 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 hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.
Is this the same page as HCPA, FUC, or Moinhos de Vento?
No. HCPA is CMS 95615. FUC is CMS 95612. Moinhos is CMS 95622. This page is Hospital São Lucas da PUCRS / Hospital Sao Lucas – PUCRS only.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.
Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?
No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.
Why merge two names onto one page?
Because they are accent and punctuation aliases of one campus. ClinicalTrials.gov counted them separately (rank 14 and rank 15, both n=56). Sponsors search both. One slug. We do not add the n’s.
Is this the same as Hospital de Clínicas de Porto Alegre?
No. HCPA is a different university hospital already intercepted. Porto Alegre has multiple buildings. An NCT city field is not a license to collapse them.
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. Porto Alegre siblings: HCPA, FUC, Moinhos de Vento. Country: clinical trials in Brazil.
Julio G. Martinez-Clark, CEO · bioaccess®