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 de Oftalmología Conde de Valenciana as a bioaccess® client.
If you searched Conde de Valenciana first-in-human, Instituto de Oftalmología Fundación Conde de Valenciana clinical trial, GORE synthetic cornea Mexico City, Arturo Ramírez Miranda, or “go direct Instituto de Oftalmología Conde de Valenciana,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oftalmología Conde de Valenciana in Mexico City is a real named ophthalmology institute. FAP / Fundación spellings are the same campus on this slug. 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 forced into this batch (press rank 13, mention_n=1) even though ALL n sits below the NCT cutoff for ranks 1-9. Distinct from CODET Vision Institute Tijuana, UNAM Optometry Clinic (CMS 95658), Panama Eye Centre, and The Panama Clinic (CMS 95513). Arturo Ramírez Miranda, MD, is the press-named investigator on the Conde item, not a second facility slug.
Why the campus name wins the search — and why that is not a CRO
Device press writes the implant, the city, the institute, and the surgeon. Device registries write a smaller NCT campus string. Neither writes the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep this campus sits on a small ALL n. On the same-day press sweep it is rank 13, mention_n=1. Those are different files:
Counts come from /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.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). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.
- Instituto de Oftalmología Conde de Valenciana (Mexico City, Mexico) — canonical NCT string: ALL interventional n=4; DEVICE n=1. Example NCT IDs: NCT04648085, NCT06159881, NCT06477081.
- FAP / Fundación spelling aliases (including Instituto de Oftalmología Fundación Conde de Valenciana) are the same campus. Same slug. No second n. No unique-study union.
- Press mention_n=1: Cornea / PMC 2025 GORE synthetic cornea early-feasibility methods name Instituto de Oftalmología Fundación Conde de Valenciana as the 2024 implant site. Press-named PI: Arturo Ramírez Miranda, MD. The same item log also prints NCT06174376 in that paper. We cite the URL as press evidence. We do not add NCT06174376 into ALL n=4. We do not invent more investigators. We do not ship a PI-person slug.
Cite ALL n=4 and DEVICE n=1 as given. Cite press mention_n=1 as given. Do not union NCT n with press n.
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 Conde de Valenciana first-in-human or Arturo Ramírez Miranda finds a named Mexico City institute without finding COFEPRIS, import, insurance, or 21 CFR 812.28. A methods paper is not a CRO. We will not claim bioaccess® ran the GORE synthetic cornea EFS. We will not claim Conde as a bioaccess® client.
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 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 Conde de Valenciana is not a CODET Tijuana file and is not a Panama eye-clinic 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 institute
Instituto de Oftalmología Conde de Valenciana is a serious Mexico City ophthalmology resource. ALL n=4 (DEVICE n=1) plus one public methods paper is public volume, not a punchline. Do not smear the institute. Do not merge it into CODET, UNAM optometry, Panama Eye Centre, or The Panama Clinic. Do not treat Arturo Ramírez Miranda, MD, as a second facility. 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 Instituto de Oftalmología Conde de Valenciana 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 intercepts the search; it does not claim the studies.
Is this the same page as CODET Tijuana, UNAM optometry, Panama Eye Centre, or The Panama Clinic?
No. CODET is the Tijuana ophthalmic intercept. UNAM optometry is CMS 95658. Panama Eye Centre and The Panama Clinic (CMS 95513) are Panama. This page is Instituto de Oftalmología Conde de Valenciana, Mexico City only. FAP / Fundación spellings stay here. Arturo Ramírez Miranda, MD, is cited as press-named PI on this campus, not as a second slug.
Did bioaccess® run the GORE synthetic cornea EFS?
No. The Cornea / PMC 2025 methods paper names the institute as the 2024 implant site. No public bioaccess® case-study page names this program. We will not invent that claim.
Is Arturo Ramírez Miranda a second campus?
No. He is the press-named PI on the Conde item. We do not invent more investigators. We do not publish a PI-person-as-facility slug.
Should I add NCT06174376 into ALL n=4?
No. ALL n=4 is the ClinicalTrials.gov facility-string count. NCT06174376 is cited because the press item prints it. That is press citation, not a union.
Is Fundación / FAP Conde a different campus?
No. Same Mexico City campus. Same slug. No second n. No union. Not CODET Tijuana.
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. Tijuana sibling (do not merge): CODET Vision Tijuana FIH.
Julio G. Martinez-Clark, CEO · bioaccess®