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 Centro Médico Viamonte as a bioaccess® client.
If you searched Centro Medico Viamonte first-in-human, Viamonte Buenos Aires clinical trial, Centro Médico Viamonte CRO, or “go direct Centro Médico Viamonte,” you followed a campus string ClinicalTrials.gov still publishes. Centro Médico Viamonte in Buenos Aires, Argentina, is a real named clinic string on ClinicalTrials.gov, on Viamonte. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Buenos Aires clinic on Viamonte. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), Hospital Británico de Buenos Aires (CMS 95654), CIPREC (CMS 95641), Hospital Universitario Austral (CMS 95638), ENERI / Sagrada Familia (CMS 95625), and Fundación Respirar (CMS 95653). Sharing Buenos Aires is not a license to collapse them.
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 /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.
- Centro Médico Viamonte (Buenos Aires, Argentina): ALL interventional n=32; DEVICE n=0 on the picks file. Batch-5 pick #10. Example NCT IDs: NCT03952143, NCT04184622, NCT04255433.
Cite ALL n=32 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not merge another Buenos Aires ALL-n=32 leftover onto this slug.
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 clinic as a client site.
That is the leak: a founder searching “Centro Médico Viamonte clinical trial” finds ALL n=32 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Británico, CIPREC, Austral, ENERI, or Respirar. A named clinic on Viamonte is still not a CRO.
The site is the site. The CRO is the operator.
A named clinic 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 clinic 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 clinic 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. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
- 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 clinic
Centro Médico Viamonte is a serious named Buenos Aires clinic on the public registry. ALL n=32 is registry volume, not a punchline. Do not merge it into HIBA, Británico, CIPREC, Austral, ENERI/Sagrada Familia, or Fundación Respirar. 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 Centro Médico Viamonte directly for a device FIH?
You can try. The clinic 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as HIBA, Británico, CIPREC, Austral, ENERI, or Fundación Respirar?
No. HIBA is CMS 95620. Británico is CMS 95654. CIPREC is CMS 95641. Austral is CMS 95638. ENERI / Sagrada Familia is CMS 95625. Fundación Respirar is CMS 95653. This page is Centro Médico Viamonte only.
Is this the same clinic as CIPREC or ENERI?
No. CIPREC is CMS 95641. ENERI is CMS 95625. Viamonte is a different NCT string on a different named clinic.
Does ALL n=32 mean this clinic already owns ANMAT?
No. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate. An NCT location row is not that file.
Did bioaccess® run NCT04184622 because it also appears on CEDOES in this batch?
No. An NCT ID can list more than one facility. 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. Country: clinical trials in Argentina. Buenos Aires sibling: Hospital Italiano de Buenos Aires.
Julio G. Martinez-Clark, CEO · bioaccess®