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 ANMAT, 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 Instituto de Oncología de Rosario as a bioaccess® client.
If you searched Instituto de Oncologia de Rosario first-in-human, Instituto de Oncología Rosario clinical trial, IOR Rosario CRO, or “go direct Instituto de Oncología de Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oncología de Rosario in Rosario, Argentina, is a real named oncology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.
bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, 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 institute still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Rosario oncology institute. It is not Hospital Provincial del Centenario, not INECO, not Fundación de Estudios Clínicos Rosario, not Sanatorio Parque, not ICESP, not Barretos, not A.C. Camargo, and not CORI. Sharing Rosario or sharing an oncology search is not a license to collapse them. Unaccented Instituto de Oncologia de Rosario is a spelling alias on this page, not a second page.
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), this campus sits here after filters:
Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.
- Instituto de Oncología de Rosario (Rosario, Argentina) — canonical NCT string: ALL interventional n=24; DEVICE n=0. Example NCT IDs: NCT01026142, NCT01572038, NCT01641939.
- Unaccented alias Instituto de Oncologia de Rosario: ALL n=22. Listed separately. Same page. We do not invent a combined unique-study total of 24+22. We do not ship a second page for the missing accent.
These counts are not added together. 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 institute as a client site.
That is the leak: a founder searching “Instituto de Oncología de Rosario clinical trial” or “IOR Rosario FIH” finds canonical ALL n=24 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. A named oncology institute is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named institute 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 institute 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 institute is not built to own for an investigational device:
- ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at this Rosario institute is not a Centenario, INECO, Estudios Clínicos, Parque, ICESP, Barretos, Camargo, or CORI 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 ANMAT actually works (the short version)
Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.
Ask for a protocol-specific calendar. A hospital email is not ANMAT 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.
Not a critique of the institute
Instituto de Oncología de Rosario is a serious named Rosario oncology resource on the public registry. ALL n=24 is registry volume, not a punchline. It is separate from Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. 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 ANMAT / 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract Instituto de Oncología de Rosario directly for a device FIH?
You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT 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 institute. We will not invent that claim. This page answers the search; it does not claim the studies.
Is this the same page as Centenario, INECO, Estudios Clínicos Rosario, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI?
No. Centenario has its own page. INECO has its own page. Estudios Clínicos Rosario has its own page. Sanatorio Parque has its own page. ICESP has its own page. Barretos has its own page. Camargo has its own page. CORI has its own page. This page is Instituto de Oncología de Rosario only. Unaccented ALL n=22 stays listed separately; we do not combine them.
Should I add canonical ALL n=24 and unaccented ALL n=22?
No. Alias n is listed separately. A combined unique-study total is not published. The missing accent is the same Rosario campus on the same page.
Is this ICESP, Barretos, or A.C. Camargo?
No. Those are Brazilian oncology pages already published. This page is Rosario, Argentina.
Why DEVICE n=0?
That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=24 is still not ANMAT authorization.
Did bioaccess® run NCT01026142?
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. Rosario sibling (do not merge): Fundación de Estudios Clínicos Rosario. São Paulo oncology sibling (do not merge): A.C. Camargo.
Julio G. Martinez-Clark, CEO · bioaccess®