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 ISP, 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 Carlos Van Buren Valparaíso as a bioaccess® client.
If you searched Hospital Carlos Van Buren first-in-human, Van Buren Valparaíso clinical trial, Hospital Carlos Van Buren CRO Chile, or “go direct Hospital Carlos Van Buren Valparaíso,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Carlos Van Buren in Valparaíso, Chile, is a real named public-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, Ethical-Scientific Committee (Law 20.120), 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 named Valparaíso hospital. It is not Hospital Clínico Universidad Católica (CMS 95626), not Hospital Clínico Universidad de Chile (CMS 95665), not Universidad Andrés Bello (CMS 95657), not FALP (CMS 95698), and not Biomedica Research Group Santiago (CMS 95726). Valparaíso is not Santiago. Sharing Chile 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 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 We do not publish a unique-study union across alias strings.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.
- Hospital Carlos Van Buren (Valparaíso, Chile) — canonical NCT string: ALL interventional n=20; DEVICE n=3. Example NCT IDs: NCT00022516, NCT00403208, NCT00553410.
Cite canonical ALL n=20 and DEVICE n=3. We will not invent an alias union with Santiago university hospitals. We will not invent PAHO/WHO Level 4 standing for ISP.
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 “Hospital Carlos Van Buren first-in-human” or “Van Buren Valparaíso clinical trial” finds canonical ALL n=20 (DEVICE n=3) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, FALP, or Biomedica Santiago. A named Valparaíso hospital is still a site. An NCT location row is not a CRO.
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:
- ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation in Valparaíso is not a Católica, UChile, UNAB, FALP, or Biomedica Santiago 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 ISP actually works (the short version)
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.
Ask for a protocol-specific calendar. A hospital email is not ISP 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 hospital
Hospital Carlos Van Buren is a serious named Valparaíso public hospital on the public registry. ALL n=20 and DEVICE n=3 are registry volume, not a punchline. Do not invent PAHO/WHO Level 4 for ISP. Do not merge it into Santiago campuses. 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 ISP / 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 Carlos Van Buren Valparaíso 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 ISP 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.
Is this the same page as Católica, UChile, FALP, or Biomedica Research Group Santiago?
No. Católica is CMS 95626. UChile is CMS 95665. FALP is CMS 95698. Biomedica Santiago is CMS 95726. This page is Hospital Carlos Van Buren, Valparaíso only.
Is this a Santiago university hospital?
No. Valparaíso versus Santiago is the filter. Católica, UChile, UNAB, FALP, and Biomedica Santiago stay on their own slugs.
Does ISP have PAHO/WHO Level 4 standing?
We will not invent that claim on this page. Use the live Chile country page. Typical ISP review ~30 business days; commercial ISP registration 30–90 days is a different file.
Why DEVICE n=3?
That is the ranking-table DEVICE count. It is still not ISP authorization.
Did bioaccess® run NCT00022516?
No. We cite it as facility evidence. We will not invent a sponsor or 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 Chile. Santiago sibling (do not merge): Biomedica Research Group Santiago.
Julio G. Martinez-Clark, CEO · bioaccess®