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 Instituto Nacional de Cardiología Ignacio Chávez as a bioaccess® client.
If you searched Instituto Nacional de Cardiologia Ignacio Chavez first-in-human, Ignacio Chávez clinical trial, INC Ignacio Chávez CRO Mexico, or “go direct Instituto Nacional de Cardiología Ignacio Chávez,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cardiologia Ignacio Chavez in Mexico City is a real named national cardiology-institute 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.
This page is the named Mexico City national cardiology institute. It is not INCMNSZ, not Instituto Nacional de Cancerología (INCan,), not Hospital Cardiologica Aguascalientes, not InCor, and not HCor. Sharing a cardiology search is not a license to collapse them. Accented Instituto Nacional de Cardiología Ignacio Chávez and Tlalpan / México city-label strings are the same campus on this page; we do not ship a second page.
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.
- Instituto Nacional de Cardiologia Ignacio Chavez (Mexico City, Mexico) — canonical NCT string: ALL interventional n=23; DEVICE n=1. Example NCT IDs: NCT00517738, NCT00578786, NCT00777920.
- Accented alias Instituto Nacional de Cardiología Ignacio Chávez: ALL n=8. Listed separately. Same page. We do not invent a combined unique-study total of 23+8. We do not ship a second page for the accents.
- Tlalpan city-label string: ALL n=4. Listed separately. Same campus. Same page. No combined total.
- México city-label strings are the same campus on this page, not a second page. We do not invent an extra unique-study count for those labels.
These counts are not added together.
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 institute as a client site.
That is the leak: a founder searching “Ignacio Chávez first-in-human” or “Instituto Nacional de Cardiología Ignacio Chávez clinical trial” finds canonical ALL n=23 (DEVICE n=1) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Hospital Cardiologica Aguascalientes, InCor, or HCor. A named national institute is still a site. An NCT location row is not a CRO.
The site is the site. The CRO is the operator.
A named institute 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 institute 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 institute is not built to own for an investigational device:
- COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation at Ignacio Chávez is not an INCMNSZ file, not an INCan file, not an Aguascalientes cardiology file, and not an InCor or HCor 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 in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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.
Not a critique of the institute
Instituto Nacional de Cardiologia Ignacio Chavez is a serious named Mexico City national cardiology institute on the public registry. ALL n=23 and DEVICE n=1 are registry volume, not a punchline. It is separate from INCMNSZ, INCan, Hospital Cardiologica Aguascalientes, InCor, or HCor. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $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 Instituto Nacional de Cardiología Ignacio Chávez directly for a device FIH?
You can try. The institute 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 institute. We will not invent that claim. This page answers the search; it does not claim the studies.
Is this the same page as INCMNSZ, INCan, Hospital Cardiologica Aguascalientes, InCor, or HCor?
No. INCMNSZ has its own page. INCan has its own page. Hospital Cardiologica Aguascalientes has its own page. InCor has its own page. HCor has its own page. This page is Instituto Nacional de Cardiologia Ignacio Chavez only. Accented ALL n=8 and Tlalpan ALL n=4 stay listed separately; we do not combine them.
Should I add canonical ALL n=23, accented ALL n=8, and Tlalpan ALL n=4?
No. Alias n is listed separately. A combined unique-study total is not published. Accents and Tlalpan / México city-label strings stay on this page.
Is this INCMNSZ or INCan?
No. INCMNSZ has its own page. INCan has its own page. Those are other Mexico City national-institute pages. This page is the cardiology institute only.
Why DEVICE n=1?
That is the ranking-table DEVICE count for this string. It is still not COFEPRIS authorization. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Registro sanitario (~30 working days) is a separate file.
Did bioaccess® run NCT00517738?
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. Mexico City sibling (do not merge): INCMNSZ. INCan sibling: Instituto Nacional de Cancerología.
Julio G. Martinez-Clark, CEO · bioaccess®