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 CIPREC as a bioaccess® client.
If you searched CIPREC first-in-human, CIPREC Buenos Aires clinical trial, CIPREC CRO Argentina, or “go direct CIPREC,” you followed a campus string ClinicalTrials.gov still publishes. The NCT facility string is CIPREC, Buenos Aires, Argentina. We name only that registry string. We will not invent an expansion of the CIPREC acronym. 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 hospital 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.
This page is the CIPREC Buenos Aires intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), Sagrada Familia / ENERI (CMS 95625), Hospital Universitario Austral (CMS 95638), Hospital Italiano de La Plata (this batch), and Hospital Italiano Asunción (CMS 95517). Linking is correct. Collapsing Buenos Aires, Pilar, La Plata, and Asunción because they share a language 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 studies; all years; complete dump), this campus sits here after filters:
- CIPREC (Buenos Aires, Argentina): ALL interventional n=55 (rank 16). Example NCT IDs: NCT00094302, NCT03383146, NCT03420781.
Cite ALL only as given. We will not invent a DEVICE n or an acronym expansion.
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 hospital as a client site.
That is the leak: a founder searching “CIPREC clinical trial” finds rank 16 on ALL (n=55) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Austral, ENERI, or La Plata. High ALL volume on a short facility string is still not a CRO, and not a client we invent.
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 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:
- 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 in Buenos Aires is not that file. Trial authorization and commercial registro remain separate petitions.
- 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.
Site versus CRO
| Workstream | What CIPREC (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 | ANMAT 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 CIPREC Buenos Aires NCT string — not HIBA, Austral, ENERI, La Plata, or Asunción | Colombia (INVIMA) and the rest of the bioaccess® platform |
How ANMAT actually works (the short version)
Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.
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 ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the hospital
CIPREC is a real Buenos Aires facility string with n=55 ALL. That volume is not a punchline. We will not smear it by inventing an acronym, a PI, or a client claim. Do not merge it into HIBA, Austral, ENERI, La Plata, or Asunción. 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 CIPREC 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 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 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 HIBA, Austral, ENERI, La Plata, or Hospital Italiano Asunción?
No. HIBA is CMS 95620. Austral is CMS 95638. Sagrada Familia / ENERI is CMS 95625. Asunción Italiano is CMS 95517 (DINAVISA, Paraguay). Hospital Italiano de La Plata is a separate intercept in this batch. This page is the NCT string CIPREC, Buenos Aires, Argentina only.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / 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.
What does CIPREC stand for?
We will not invent an expansion. The public ranking dump stores the facility as CIPREC, Buenos Aires, Argentina. That is the string this page intercepts.
Is the 90-business-day figure a guarantee of start-up?
No. It is a published statutory target on the trial-authorization side and the clock pauses for RFIs. Trial versus registro are separate. Ask for a protocol-specific calendar. An NCT row is not ANMAT clearance. Same Argentina hub used on the HIBA intercept (CMS 95620).
NCT00094302 also appears on another campus. Does that merge the hospitals?
No. Example IDs are facility evidence from the dump. Shared NCT IDs across location rows do not make CIPREC the same building as Hospital Italiano de La Plata or HIBA. We still will not invent a PI.
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®