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 facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital de Clínicas de Porto Alegre as a bioaccess® client.
If you searched Hospital de Clínicas de Porto Alegre first-in-human, HCPA clinical trials, Hospital de Clinicas de Porto Alegre CRO, or “go direct HCPA Brazil,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Clínicas de Porto Alegre (HCPA) in Porto Alegre, Rio Grande do Sul, is a real university hospital. 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 Porto Alegre 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 three registry spellings of the same campus. ClinicalTrials.gov stores them as separate facility strings; we do not. Accented Hospital de Clínicas de Porto Alegre, unaccented Hospital de Clinicas de Porto Alegre, and Hospital de Clinicas e Porto Alegre (HCPA) are one page. It does not clone Fundação Universitaria de Cardiologia Porto Alegre (CMS 95612). That is a different hospital, on a different NCT (Polares MRace / NCT06113354). Linking is correct. Cloning that Polares page is not.
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 DEVICE studies; all years; complete dump), this campus sits at the top of named Brazilian device facilities after filters:
- Hospital de Clínicas de Porto Alegre (accented): DEVICE rank 1, n=30. Example NCT IDs: NCT00761280, NCT00921791, NCT02105064.
- Hospital de Clinicas de Porto Alegre (unaccented): DEVICE rank 3, n=26. Example NCT IDs: NCT00489463, NCT00929175, NCT01133223.
- Hospital de Clinicas e Porto Alegre (HCPA): DEVICE rank 36, n=5. Example NCT IDs: NCT01954277, NCT02432677, NCT03744897.
On the same sweep’s ALL interventional ranking (not device-only): accented n=293 (rank 1) and unaccented n=213 (rank 2). 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 not a quality score. They are how a sponsor searching “Porto Alegre hospital clinical trial” lands on a campus without landing on an operator.
Public snapshots of those example IDs show mixed hospital- and industry-sponsored interventional work. 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.
The site is the site. The CRO is the operator.
A Porto Alegre university hospital can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on hundreds of 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 CEP 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 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Porto Alegre 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 into Brazil is 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 an HCPA-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 Porto Alegre enrollment or the indication later needs São Paulo, Bogotá, or Panama City, a single-hospital MSA will not stretch.
Going direct to Hospital de Clínicas de Porto Alegre is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What HCPA (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, caseload, 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 | Hospital 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 Porto Alegre campus (three NCT spellings, one building) | 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 — and do not merge Porto Alegre buildings
Hospital de Clínicas de Porto Alegre is a serious academic resource. Ranking first on a public DEVICE facility list is a signal of registry volume, not a punchline. This page is not a critique of that work. Volume on ClinicalTrials.gov is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.
Do not merge this campus into Fundação Universitaria de Cardiologia. Do not merge it into São Paulo intercepts already live: InCor HCFMUSP and Instituto Dante Pazzanese. Different buildings. Different queries.
What the CRO still does after you have an HCPA slide
- Regulatory-fit, not tourism. Brazil is a sourced device geography. One Porto Alegre 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/CEP packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate HCPA 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 de Clínicas de Porto Alegre directly for a device FIH?
You can try. The hospital can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by ranking high 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 n=30+26+5 (DEVICE) and n=293+213 (ALL) are ClinicalTrials.gov counts, not bioaccess® enrollment.
Is this the same hospital as Fundação Universitaria de Cardiologia?
No. Fundação Universitaria de Cardiologia is a different Porto Alegre facility already intercepted for Polares MRace (NCT06113354). This page is the HCPA campus-string intercept.
If I already have HCPA, what does the CRO still do?
Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design); the ANVISA/CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.
Next step
If the search that brought you here was Hospital de Clínicas de Porto Alegre or HCPA, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Other Porto Alegre hospital: Fundação Universitaria de Cardiologia.
Julio G. Martinez-Clark, CEO · bioaccess®