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 Cancerología as a bioaccess® client.
If you searched Instituto Nacional de Cancerologia first-in-human, INCan Mexico City clinical trial, INCan CRO Mexico, or “go direct Instituto Nacional de Cancerología,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cancerología (INCan) in Mexico City is a real national cancer-institute string on ClinicalTrials.gov. It is not INCMNSZ, not a Brazil campus, and not CODET Tijuana. 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 is the Mexico City INCan page. Distinct from INCMNSZ Salvador Zubirán (InCor HCFMUSP is Brazil and is not this campus). Distinct from CODET Vision Institute Tijuana, Hospital Universitario Eleuterio González (Monterrey), Hospital Civil de Guadalajara Fray Antonio Alcalde, and UNAM Optometry Clinic (separate page). Two national institutes in Mexico City are still two NCT strings.
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:
- Instituto Nacional de Cancerologia (Mexico City, Mexico): ALL interventional n=40 (rank 40). Example NCT IDs: NCT00036647, NCT00395655, NCT00532818.
We will not invent a DEVICE n or a sponsor-class split the registry pull did not print on this instruction set.
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 hospital as a client site.
That is the leak: a founder searching “INCan clinical trial” or “Instituto Nacional de Cancerología FIH” finds rank 40 on ALL (n=40) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, CODET, Eleuterio, Fray Antonio, or UNAM optometry. A national cancer-institute ranking is registry volume, not a CRO, and not a Brazil InCor duplicate.
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 local 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 committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation at INCan is not that file, and it is not an INCMNSZ 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-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 Instituto Nacional de Cancerología (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 | COFEPRIS 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 INCan Mexico City NCT string — not INCMNSZ, CODET, Eleuterio, Fray Antonio, or UNAM optometry | Colombia (INVIMA) and the rest of the bioaccess® platform |
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.
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 hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.
Not a critique of the hospital
Instituto Nacional de Cancerología is a serious Mexico City national institute. n=40 ALL (rank 40) is registry volume, not a punchline. It is separate from INCMNSZ, CODET Tijuana, Eleuterio Monterrey, Fray Antonio Guadalajara, or UNAM optometry. 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 review in both Panama and Colombia runs on 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 Cancerología 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 answers 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 INCMNSZ, CODET Tijuana, Eleuterio González, Fray Antonio, or UNAM Optometry Clinic?
No. INCMNSZ has its own page. InCor HCFMUSP is a Brazil campus. CODET is Tijuana. Eleuterio has its own page (Monterrey). Fray Antonio has its own page (Guadalajara). UNAM Optometry Clinic has its own page. This page is Instituto Nacional de Cancerología, Mexico City only.
If I already have this campus, what does the CRO still do?
Regulatory-fit (this country versus Colombia versus a multi-site design); the COFEPRIS / 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 hospital 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.
Is INCan the same as INCMNSZ?
No. INCMNSZ has its own page. INCan is Instituto Nacional de Cancerología. Sharing Mexico City does not merge the files.
Is this InCor / HCFMUSP?
No. InCor is in Brazil. The INCMNSZ page is INCMNSZ Salvador Zubirán.
Is there a guaranteed start-up time for this institute?
No. Ethics committee review comes first, then COFEPRIS review, and we confirm the calendar per protocol. Registro sanitario (~30 working days) is a separate petition.
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. INCMNSZ sibling: INCMNSZ Salvador Zubirán.
Julio G. Martinez-Clark, CEO · bioaccess®