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 Centenario Hospital Miguel Hidalgo as a bioaccess® client.
If you searched Centenario Hospital Miguel Hidalgo first-in-human, Hospital Miguel Hidalgo Aguascalientes clinical trial, Miguel Hidalgo CRO Mexico, or “go direct Centenario Hospital Miguel Hidalgo,” you followed a campus string ClinicalTrials.gov still publishes. Centenario Hospital Miguel Hidalgo in Aguascalientes, Mexico, is a real named public-hospital string on ClinicalTrials.gov. 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 named Aguascalientes public hospital. It is not Hospital Provincial del Centenario in Rosario (CMS 95649) and it is not Hospital Cardiologica Aguascalientes (CMS 95693). “Centenario” in Rosario is a different country and a different city. Sharing Aguascalientes is not a license to collapse this hospital into the cardiology clinic already live there.
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 /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.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; 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 We do not publish a unique-study union across alias strings.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.
- Centenario Hospital Miguel Hidalgo (Aguascalientes, Mexico) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT00269828, NCT00920816, NCT01120184.
Cite canonical ALL n=23 and DEVICE n=0. We will not invent an alias union with Rosario Centenario or with Hospital Cardiologica Aguascalientes. We will not invent a DEVICE n. We do not ship a second slug for this campus.
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 Miguel Hidalgo Aguascalientes first-in-human” or “Centenario Hospital Miguel Hidalgo clinical trial” finds canonical ALL n=23 (DEVICE n=0) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes. A named public hospital is still a site. An NCT location row 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. A hallway conversation at Miguel Hidalgo is not a Rosario Centenario file and is not a Hospital Cardiologica Aguascalientes 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
Centenario Hospital Miguel Hidalgo is a serious named Aguascalientes public hospital on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Hospital Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes. Do not invent a PI. 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 Centenario Hospital Miguel Hidalgo 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 Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes?
No. Hospital Provincial del Centenario is CMS 95649 in Rosario, Argentina — different country, different city. Hospital Cardiologica Aguascalientes is CMS 95693, a different NCT string in the same Mexican city. This page is Centenario Hospital Miguel Hidalgo only.
Is this Hospital Provincial del Centenario in Rosario?
No. Rosario Centenario is CMS 95649. Argentina versus Mexico is the filter. “Centenario” in the name is not a merge key.
Is this Hospital Cardiologica Aguascalientes?
No. That is CMS 95693. Same city is not the same hospital. This page is Centenario Hospital Miguel Hidalgo.
Why DEVICE n=0?
That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=23 is still not COFEPRIS authorization. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median start-up on the Mexico hub; registro ~30 working days.
Did bioaccess® run NCT00269828?
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. Mexico hub: clinical trials in Mexico. Aguascalientes sibling (do not merge): Hospital Cardiologica Aguascalientes. Rosario sibling (do not merge): Hospital Provincial del Centenario.
Julio G. Martinez-Clark, CEO · bioaccess®