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 Centro de Investigación Clínica de Oaxaca as a bioaccess® client.
If you searched Centro de Investigacion Clinica de Oaxaca first-in-human, Oaxaca City clinical trial, CICO Oaxaca CRO, or “go direct Centro de Investigación Clínica de Oaxaca,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigación Clínica de Oaxaca in Oaxaca City, Mexico, is a real named research-clinic 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.
This page is the Oaxaca named research clinic. Distinct from INCMNSZ Salvador Zubirán (CMS 95623), INCan (CMS 95655), Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646), UNAM Optometry Clinic (CMS 95658), and Hospital Universitario Dr. José Eleuterio González (CMS 95643). Oaxaca City is not Mexico City, not Guadalajara, not Monterrey, and not a UNAM optometry lab.
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-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.
- Centro de Investigacion Clinica de Oaxaca (Oaxaca City, Mexico): ALL interventional n=33; DEVICE n=0 on the picks file. Batch-5 pick #6. Example NCT IDs: NCT03498716, NCT03899155, NCT04365868.
Cite ALL n=33 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI.
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 clinic as a client site.
That is the leak: a founder searching “Oaxaca clinical trial clinic” or “Centro de Investigación Clínica de Oaxaca FIH” finds ALL n=33 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Guadalajara, UNAM optometry, or Eleuterio González. A named Oaxaca clinic is still not a CRO.
The site is the site. The CRO is the operator.
A named clinic 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 clinic 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 clinic 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 in Oaxaca 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 clinic
Centro de Investigación Clínica de Oaxaca is a serious named clinic on the public registry. ALL n=33 is registry volume, not a punchline. Do not merge it into INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González. 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 Centro de Investigación Clínica de Oaxaca directly for a device FIH?
You can try. The clinic 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González?
No. INCMNSZ is CMS 95623 (Mexico City). INCan is CMS 95655 (Mexico City). Hospital Civil Guadalajara is CMS 95646. UNAM optometry is CMS 95658. Eleuterio González is CMS 95643 (Monterrey). This page is Centro de Investigación Clínica de Oaxaca, Oaxaca City only.
Is Oaxaca under a different national agency than Mexico City?
No. COFEPRIS is still the national file. Ethics typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. Registro sanitario (~30 working days) is a different file.
Does ALL n=33 mean this clinic already owns COFEPRIS?
No. An NCT location row is not a COFEPRIS authorization. Keep trial clocks separate from registro.
Why DEVICE n=0?
That is the picks-file DEVICE count. We will not invent a DEVICE n from the CSV top-40 dump.
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.
Julio G. Martinez-Clark, CEO · bioaccess®