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 Erasto Gaertner as a bioaccess® client.
If you searched Hospital Erasto Gaertner first-in-human, Erasto Gaertner Curitiba clinical trial, Erasto Gaertner CRO, or “go direct Hospital Erasto Gaertner,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Erasto Gaertner in Curitiba, Brazil, is a real hospital string on ClinicalTrials.gov. Curitiba is not Porto Alegre and not São Paulo. 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 the Curitiba Erasto Gaertner intercept. Distinct from Porto Alegre campuses (HCPA, Moinhos, PUCRS, Conceição, Dornelles, Santa Casa) and from São Paulo-state cancer campuses (ICESP, Barretos). Paraná is not Rio Grande do Sul and not the capital of São Paulo.
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:
- Hospital Erasto Gaertner (Curitiba, Brazil), DEVICE list: n=5 (rank 38). INDUSTRY:2; OTHER:2; NETWORK:1. Example NCT IDs: NCT00385983, NCT03368313, NCT03721978.
- Same facility on the ALL interventional list: n=55 (rank 18). INDUSTRY:42; OTHER:11; NETWORK:2. Example NCT IDs: NCT00083304, NCT00382031, NCT00385983.
Cite DEVICE and ALL as given. NCT00385983 appears on both example sets because the dump printed it on both rows. That overlap does not merge Curitiba into Porto Alegre or ICESP.
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 campus 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 “Erasto Gaertner clinical trial” finds both a DEVICE campus (n=5, rank 38) and an ALL campus (n=55, rank 18) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, or any Porto Alegre hospital. Curitiba registry volume is still not a CRO. NETWORK tokens are not named networks we invent as clients.
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 local 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 in Curitiba is not that dossier, and it is not an ICESP, Barretos, or 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-site 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 Hospital Erasto Gaertner (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 | One Curitiba hospital NCT string (DEVICE and ALL listed separately) — not Porto Alegre campuses, ICESP, or Barretos | Colombia (INVIMA) and the rest of the bioaccess® platform |
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.
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.
Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the hospital
Hospital Erasto Gaertner is a serious Curitiba resource. DEVICE n=5 (rank 38) and ALL n=55 (rank 18) are registry volume, not a punchline. Do not merge it into Porto Alegre campuses or into ICESP or Barretos. 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 Erasto Gaertner 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, ICESP, or Barretos Cancer Hospital?
No. HCPA is CMS 95615 (Porto Alegre). ICESP is CMS 95642 (São Paulo). Barretos is CMS 95648. This page is Hospital Erasto Gaertner, Curitiba only. DEVICE and ALL are two filters on one facility string, not two hospitals.
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 cite both DEVICE n=5 and ALL n=55?
The 1 September 2026 dump published both rows for this facility string. DEVICE rank 38 (n=5; INDUSTRY:2; OTHER:2; NETWORK:1) and ALL rank 18 (n=55; INDUSTRY:42; OTHER:11; NETWORK:2). We cite both. We do not pretend DEVICE n is ALL n.
Does NCT00385983 on both lists merge this campus with ICESP?
No. Shared example IDs across filters are facility evidence. They do not move Curitiba to São Paulo. We still will not invent a PI.
Is Curitiba a Porto Alegre alias?
No. Porto Alegre campuses stay on their own intercepts. This page is Paraná.
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. Cancer-campus siblings: ICESP, Barretos.
Julio G. Martinez-Clark, CEO · bioaccess®