FALP: The NCT Campus String Is Not the ISP File

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 […]

If you searched FALP first-in-human, Fundacion Arturo Lopez Perez clinical trial, Fundación Arturo López Pérez Santiago CRO, or “go direct FALP,” you followed a campus string ClinicalTrials.gov still publishes. Fundacion Arturo Lopez Perez (FALP) in Santiago, Chile, is a real named cancer-center 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Santiago FALP campus. Distinct from Hospital Clínico Universidad Católica, Hospital Clínico Universidad de Chile, Universidad Andrés Bello, and Club de Leones Cruz del Sur. Sharing Santiago or sharing Chile is not a license to collapse them. Punta Arenas is not this campus.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

Fundacion Arturo Lopez Perez (Santiago, Chile) — ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00022516, NCT00045032, NCT00094653.
Checked against the 1 September 2026 ClinicalTrials.gov pull on the named campus string: unique NCT IDs n=30. Same campus. Not two centers.
Alias Fundación Arturo López Pérez: ALL n=11. Listed separately. Same page. No combined total.
Alias FALP: ALL n=7. Listed separately. Same page. No combined total.

These counts are not added together. DEVICE n=0; we will not pad it. 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 center as a client site.

That is the leak: a founder searching “FALP Santiago clinical trial” or “Fundacion Arturo Lopez Perez FIH” finds ALL n=25 (named-string n=30) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, or Club de Leones. A named Santiago cancer center is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named center 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 center 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 center 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 FALP is not a Católica, UChile, UNAB, or Punta Arenas 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 in 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.

Not a critique of the center

Fundacion Arturo Lopez Perez is a serious named Santiago cancer center on the public registry. ALL n=25 is registry volume, not a punchline. named-string n=30 is the same named string, not a second campus. We do not invent a DEVICE n. We do not invent PAHO/WHO Level 4 for ISP. It is separate from Católica, UChile, UNAB, or Club de Leones. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract FALP directly for a device FIH?

You can try. The center 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Hospital Clínico Universidad Católica, Hospital Clínico Universidad de Chile, Universidad Andrés Bello, or Club de Leones Cruz del Sur?

No. Católica has its own page. UChile has its own page. UNAB has its own page. Club de Leones has its own page (Punta Arenas). This page is Fundacion Arturo Lopez Perez / FALP, Santiago only. ALL n=25 is ranking; named-string n=30 is the named string; alias n=11 and n=7 stay listed separately. We do not combine.

Should I add ALL n=25, named-string n=30, alias n=11, and FALP n=7?

No. ALL n=25 is the ranking row. named-string n=30 is the same named string confirmed. Alias n is listed separately. A combined unique-study total is not published.

Is FALP a Santiago university hospital?

No. Católica, UChile, and UNAB remain on their own pages. This page is Fundacion Arturo Lopez Perez.

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.

Did bioaccess® run NCT00022516?

No. 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 Chile. Santiago sibling (do not merge): Hospital Clínico Universidad de Chile.

Julio G. Martinez-Clark, CEO · bioaccess®