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 Club de Leones Cruz del Sur as a bioaccess® client.
If you searched Club de Leones Cruz del Sur first-in-human, Corporación de Rehabilitación Club de Leones Punta Arenas clinical trial, Cruz del Sur Magallanes CRO, or “go direct Club de Leones Cruz del Sur,” you followed a campus string ClinicalTrials.gov still publishes. Corporación de Rehabilitación Club de Leones Cruz del Sur in Punta Arenas, Chile, is a real Magallanes rehab-hospital string on ClinicalTrials.gov. It is a unique Magallanes rehab hospital. It is not a Santiago university hospital. 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 Punta Arenas / Magallanes rehab-hospital intercept. Distinct from Hospital Clínico Universidad de Chile (CMS 95665), Hospital Clínico Universidad Católica (CMS 95626), and Universidad Andrés Bello (CMS 95657). Punta Arenas is not Santiago. A rehab hospital in Magallanes is not Católica, not UChile, and not UNAB. Linking is correct. Collapsing every Chilean campus into Santiago 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:
Counts come from leftover rows in /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md 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). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.
- Corporación de Rehabilitación Club de Leones Cruz del Sur (Punta Arenas, Chile) — canonical NCT string: ALL interventional n=9; DEVICE n=8. Example NCT IDs: NCT04228224, NCT04245059, NCT04249349.
Cite ALL n=9 and DEVICE n=8 as given. We will not invent a global CSV rank. We will not invent PAHO/WHO Level 4 standing for ISP. We will not merge this Magallanes campus into Santiago university hospitals.
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 “Club de Leones Cruz del Sur clinical trial” or “Punta Arenas rehab FIH” finds ALL n=9 (DEVICE n=8) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on UChile, Católica, or UNAB. Magallanes is still not Santiago. A rehab hospital is still not a CRO. DEVICE n=8 on a small ALL n is registry volume, not a claim that the campus owns ISP for a new device file.
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 in Punta Arenas is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
- 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
Club de Leones Cruz del Sur is a serious Magallanes rehab hospital. ALL n=9 (DEVICE n=8) is registry volume, not a punchline. Do not merge it into UChile (CMS 95665), Católica (CMS 95626), or UNAB (CMS 95657). Do not invent PAHO/WHO Level 4 for ISP. 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 Club de Leones Cruz del Sur 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 Hospital Clínico Universidad de Chile, Hospital Clínico Universidad Católica, or Universidad Andrés Bello?
No. UChile is CMS 95665 (Santiago). Católica is CMS 95626 (Santiago). UNAB is CMS 95657 (Santiago). This page is Corporación de Rehabilitación Club de Leones Cruz del Sur, Punta Arenas, Magallanes only.
Is Punta Arenas under a different national agency than Santiago?
No. ISP is still the national file. Typical ISP review ~30 business days on Chile blogs. Commercial ISP registration 30–90 days is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit.
Does DEVICE n=8 on ALL n=9 mean this campus already owns ISP for a new device FIH?
No. DEVICE n is unique NCT IDs on the device filter for this facility string. It is not ISP authorization, not import, and not a 21 CFR 812.28 package.
Does ISP have PAHO/WHO Level 4 standing?
We will not invent that claim on this page. Use the live Chile country page for what is actually published. Typical ISP review ~30 business days; commercial ISP registration 30–90 days is a different file.
Is this a Santiago university hospital?
No. This is a unique Magallanes rehab hospital in Punta Arenas. UChile, Católica, and UNAB remain on their own slugs.
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.
Julio G. Martinez-Clark, CEO · bioaccess®