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 CAICI Rosario as a bioaccess® client.
If you searched Instituto CAICI Rosario first-in-human, CAICI clinical trial Rosario, CAICI CRO Argentina, or “go direct Instituto CAICI Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Instituto CAICI in Rosario, Argentina, is a real named clinical-research-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 CAICI institute. It is not Instituto de Investigaciones Clínicas Rosario (CMS 95723; NCT overlap 0 on this canonical string), not Instituto de Oncología de Rosario (CMS 95704; overlap 1), not Hospital Provincial del Centenario (CMS 95649), and not INECO Neurociencias Oroño (CMS 95663). Sharing Rosario is not a license to collapse them. Legal-suffix alias Instituto CAICI SRL and short alias CAICI stay on this slug; we do not ship second slugs.
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 unique strings after batch 11 (CMS 95719–95728 live) 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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Instituto CAICI (Rosario, Argentina) — canonical NCT string: ALL interventional n=21; DEVICE n=0. Example NCT IDs: NCT00080340, NCT00089804, NCT00388726.
- Legal-suffix alias Instituto CAICI SRL: ALL n=9. Listed separately. Same slug. No unique-study union of 21+9. No second slug.
- Short alias CAICI: ALL n=6. Listed separately. Same slug. No union. No second slug.
Cite canonical ALL n=21 and DEVICE n=0. Cite alias n 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 institute as a client site.
That is the leak: a founder searching “Instituto CAICI Rosario first-in-human” or “CAICI clinical trial” finds canonical ALL n=21 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on IIC Rosario, Oncología Rosario, Centenario, or INECO. A named 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 CAICI is not an IIC Rosario file, not an Oncología Rosario file, not a Centenario file, and not an INECO 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.
Do not smear the institute
Instituto CAICI is a serious named Rosario research institute on the public registry. ALL n=21 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into IIC Rosario, Oncología Rosario, Centenario, or INECO. 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 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. 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 Instituto CAICI 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 intercepts the search; it does not claim the studies.
Is this the same page as Instituto de Investigaciones Clínicas Rosario or Instituto de Oncología de Rosario?
No. IIC Rosario is CMS 95723 (NCT overlap 0). Oncología Rosario is CMS 95704 (overlap 1). This page is Instituto CAICI, Rosario only. SRL ALL n=9 and short CAICI ALL n=6 stay listed separately; we do not union.
Should I add canonical ALL n=21, SRL ALL n=9, and short ALL n=6?
No. Alias n is listed separately. A unique-study union is not published. Those strings stay on this slug.
Is this IIC Rosario or Oncología Rosario?
No. IIC Rosario is CMS 95723. Oncología Rosario is CMS 95704. Sharing Rosario is not a merge key.
Why DEVICE n=0?
That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=21 is still not ANMAT authorization. Trial versus registro remain different petitions.
Did bioaccess® run NCT00080340?
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 siblings (do not merge): IIC Rosario, Instituto de Oncología de Rosario.
Julio G. Martinez-Clark, CEO · bioaccess®