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 COFEPRIS, 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 Ángeles Andares Guadalajara as a bioaccess® client.
If you searched Hospital Angeles Andares first-in-human, Angeles Andares Guadalajara clinical trial, Innoblative SIRA Guadalajara, or “go direct Hospital Ángeles Andares Guadalajara,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Ángeles Andares in Guadalajara, Mexico, is a real hospital named in public sponsor press for a device first-in-human procedure (Innoblative SIRA® RFA, public LinkedIn item dated May 2026). It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns COFEPRIS, institutional 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 press-named Guadalajara Ángeles Andares campus. It is not Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646). Sharing Guadalajara is not a license to collapse them. We do not claim Hospital Ángeles Andares as a bioaccess® client. We do not invent a principal investigator beyond what that public press item already names.
Why the campus name wins the search — and why that is not a CRO
Device press often writes the city, the hospital, and a milestone headline. It rarely writes the CRO. On the weekday press watch (CIT / MassDevice / MDN / EVT / PR wires plus sponsor LinkedIn), this campus shows up as:
Counts come from leftover unique strings after batch 12 (CMS 95729–95738 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. Rank 8 is a press-named building (Innoblative SIRA RFA FIH, public LinkedIn May 2026), not an NCT frequency row.
- Hospital Ángeles Andares (Guadalajara, Mexico) — press-named building on an Innoblative SIRA® RFA electrosurgical-device first-in-human item (public LinkedIn, May 2026). This is not an NCT frequency rank. Example public naming: Innoblative Designs post describing clinical use at Hospital Angeles Andares, Guadalajara.
Press naming a hospital is still not COFEPRIS authorization. We will not invent NCT IDs for this page.
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 “Angeles Andares first-in-human” or “Innoblative Guadalajara” finds the hospital name in sponsor press without finding COFEPRIS, ethics, import, insurance, ISO 14155 monitoring, or 21 CFR 812.28. A press-named hospital is still a site. A LinkedIn milestone 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:
- COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that 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 COFEPRIS actually works (the short version)
Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.
Ask for a protocol-specific calendar. A hospital email is not COFEPRIS 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 Ángeles Andares is a serious Guadalajara hospital named in public device press. A FIH press item is not a smear license. Do not invent enrollment counts. Do not claim bioaccess® ran the case. 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 COFEPRIS / 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 Ángeles Andares Guadalajara 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 COFEPRIS 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 Civil de Guadalajara Fray Antonio Alcalde?
No. That is CMS 95646. This page is Hospital Ángeles Andares only.
Is this an NCT ranking page?
No. Rank 8 in this batch is a press-named building. We will not invent an ALL n or DEVICE n for it.
Is Hospital Ángeles Andares a bioaccess® client?
No live bioaccess® case-study page names this hospital as a client site. We will not invent that claim.
Did bioaccess® run the Innoblative SIRA case?
No. We cite the public press naming as facility evidence. We will not invent a CRO claim.
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. Guadalajara sibling (do not merge): Hospital Civil Fray Antonio Alcalde. Country: clinical trials in Mexico.
Julio G. Martinez-Clark, CEO · bioaccess®