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 Universidad Andrés Bello as a bioaccess® client.
If you searched Universidad Andres Bello first-in-human, UNAB Santiago clinical trial, Universidad Andrés Bello CRO Chile, or “go direct Universidad Andrés Bello,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Andrés Bello in Santiago, Chile, is a real university string on ClinicalTrials.gov. It is an NCT university campus, not Hospital Clínico Universidad Católica. 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 university campus 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 university campus still have to rebuild that stack. An NCT location row is not a CRO.
This page is the NCT university string only. Distinct from Hospital Clínico Universidad Católica (CMS 95626; slug hospital-clinico-universidad-catolica-santiago-fih). Different campus. Different query. We do not clone press-named TMVR claims onto this page. We will not invent a PI.
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:
- Universidad Andrés Bello (Santiago, Chile): DEVICE n=7 (rank 23). OTHER:7. Example NCT IDs: NCT02884427, NCT03636386, NCT04008602.
The same ranking dump has no ALL interventional row for this facility string. We will not invent an ALL n.
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 campus 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 university campus as a client site.
That is the leak: a founder searching “Universidad Andrés Bello clinical trial” or “UNAB Santiago FIH” finds a DEVICE campus (n=7, rank 23, OTHER:7) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Clínico Universidad Católica. A university DEVICE string is not a CRO.
The site is the site. The CRO is the operator.
A named university campus 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 university campus 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 local research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the university campus 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 a UNAB campus 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-site 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 Universidad Andrés Bello (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 | ISP 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 UNAB Santiago DEVICE string (no ALL row in the dump) — not Hospital Clínico Universidad Católica | Colombia (INVIMA) and the rest of the bioaccess® platform |
How ISP actually works (the short version)
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and issues investigational-device import authorizations. Live Chile blogs already put a typical ISP review in a band of about 30 business days. We will not invent a new median. 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.
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 campus email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site work.
Do not smear the university
Universidad Andrés Bello is a serious Santiago academic resource. DEVICE n=7 (rank 23, OTHER:7) is registry volume, not a punchline. Do not invent an ALL n. Do not merge it into Hospital Clínico Universidad Católica. 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 Universidad Andrés Bello directly for a device FIH?
You can try. The university campus 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 university campus. 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 Hospital Clínico Universidad Católica (CMS 95626)?
No. CMS 95626 is Hospital Clínico Universidad Católica (hospital-clinico-universidad-catolica-santiago-fih). This page is Universidad Andrés Bello, an NCT university string only. Different campus. We do not clone that intercept’s press facts.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the ISP / 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 university campus 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.
Why is there no ALL n?
The dump did not publish an ALL interventional row for this string. We cite DEVICE n=7 (rank 23, OTHER:7) only. We will not invent an ALL count.
Is this the same campus as Hospital Clínico Universidad Católica?
No. That is CMS 95626. Universidad Andrés Bello is a different NCT string. Sharing Santiago does not merge ISP files.
Is the 30-business-day ISP figure commercial registration?
No. Typical ISP review ~30 business days is the study/import side on Chile blogs. Commercial ISP registration 30–90 days is a different file. Law 20.120 still governs the Ethical-Scientific Committee. We will not invent PAHO/WHO Level 4 for ISP.
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. Distinct campus: Hospital Clínico Universidad Católica.
Julio G. Martinez-Clark, CEO · bioaccess®