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 FACH Santiago as a bioaccess® client.
If you searched Hospital FACH Santiago first-in-human, Hospital Fach clinical trial, Hospital FACH Chile CRO, Fuerza Aérea de Chile hospital CRO, or “go direct Hospital FACH Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital FACH / Hospital Fach in Santiago, Chile, is a real named military/institutional hospital-campus string on ClinicalTrials.gov (Fuerza Aérea de Chile hospital family). 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, accredited 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 named Santiago Hospital FACH campus. It is DISTINCT from Clínica Colonial Santiago, Hospital Luis Tisné Santiago, and Clínica INDISA Santiago. Sharing Santiago metro — and even sharing Levita magnetic / robotic-platform NCT rows with sibling campuses — is not a license to collapse them. Hospital FACH is not Clínica Colonial. Hospital FACH is not Hospital Luis Tisné. Hospital FACH is not Clínica INDISA. Overlapping Levita sites exist elsewhere in Chile; we do not claim FACH-only for shared studies.
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 the last live leftover-site batch 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. We do not pad DEVICE n with non-DEVICE Hospital Fuerza Aérea de Chile rows. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Hospital Fach (Santiago, Chile) — NCT string as published: DEVICE feasibility row NCT05695989 (Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System…; COMPLETED).
- Hospital FACH (Santiago, Chile) — NCT string as published: DEVICE evaluation row NCT05353777 (Clinical Evaluation of the Levita Robotic Platform; COMPLETED). Title lacks an explicit FIH token; cite as a DEVICE facility string.
List Hospital Fach and Hospital FACH separately. Same campus family (Fuerza Aérea de Chile hospital). Do not invent a union DEVICE n. Sibling Chile sites on overlapping Levita rows include Colonial, Tisné, San Borja, and INDISA — do not claim those NCT IDs as FACH-only.
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 FACH Santiago first-in-human finds Levita magnetic / robotic-platform DEVICE rows without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO. A military-hospital brand story is still 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 at Hospital FACH is not a Clínica Colonial file, not a Hospital Luis Tisné file, and not a Clínica INDISA 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 FACH Santiago is a serious named Chilean military/institutional campus on the public registry — Levita magnetic / robotic-platform DEVICE rows under Hospital Fach and Hospital FACH are real facility evidence, not a punchline. Do not invent a PI. Do not pad DEVICE volume with non-DEVICE Fuerza Aérea rows. Do not invent “Chile’s top FIH hospital” marketing. 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
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 FACH Santiago 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 Clínica Colonial Santiago or Clínica INDISA Santiago?
No. clinica-colonial-santiago-fih and clinica-indisa-santiago-fih are distinct Santiago campuses. This page is Hospital FACH / Hospital Fach only (Fuerza Aérea de Chile hospital family).
Did bioaccess® run NCT05695989 or NCT05353777?
No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies. NCT05353777 also names other Chile sites (including Clínica Indisa); do not treat it as FACH-only.
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. Santiago siblings (do not merge): Clínica Colonial Santiago, Hospital Luis Tisné Santiago, Clínica INDISA Santiago.
Julio G. Martinez-Clark, CEO · bioaccess®