Figures cited from published bioaccess® pages, CODET Vision Institute site copy, ClinicalTrials.gov, and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, DIGEMAPS/CONABIOS, DINAVISA, MINSA/CNBI, SRS/CNEIS, and FDA rules with qualified advisers. This page names only clinics, investigators, and trials those sources support. It does not invent Salvadoran clinic names.
If you searched ophthalmic first-in-human clinic Latin America, CODET Vision Tijuana clinical trials, Laser Center Santo Domingo GORE glaucoma, Adrian Ebner FIH, Panama Eye Centre MINIject, or go direct to the eye clinic and skip the CRO, you are following a site name that showed up on a clinic page or a registry listing. That search is rational. A named Latin American eye clinic or a named Asuncion PI can be a real first-in-human site. It is not the operator of the investigational file.
bioaccess®’s position is simple and it is not adversarial: the clinic or hospital is the site. The First-in-Human CRO still owns COFEPRIS / DIGEMAPS / DINAVISA / MINSA / SRS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email the surgeon still have to rebuild that stack. The clinic does not become a CRO because it is less than 20 miles from San Diego International Airport, or because ClinicalTrials.gov listed it.
This hub is the intercept for site-direct ophthalmic and small-clinic first-in-human queries. It sits next to the May 2026 essay Ophthalmic first-in-human studies in Latin America: why smaller markets often move fastest and the hospital hub LATAM FIH hospitals vs the CRO. Those pages stay the country math and the large-hospital list. This page answers the clinic-named query.
Why the clinic name wins the search — and why that is not a CRO
Device press and clinic marketing write the implant, the city, the operating room, and the surgeon. They rarely write the CRO. A U.S. board then Googles the clinic as if it were the vendor. Four public, sourced examples, each verified live on 23 August 2026:
- CODET Vision Institute, Tijuana, Mexico. CODET’s own clinical-research page says its ophthalmologists work with industry from first-in-human through commercialization and beyond, and that the institute sits less than 20 miles south of San Diego International Airport. Dr. Arturo Chayet is the named founder and long-running investigator. Classic site-direct pattern: a sponsor flies San Diego to Tijuana and treats the clinic as the whole stack.
- Laser Center, Santo Domingo, Dominican Republic. ClinicalTrials.gov NCT05557058 — GORE Glaucoma Drainage Implant early feasibility, sponsor W. L. Gore and Associates — lists the single site as Laser Center, Santo Domingo. Independent registry mirrors name Juan F. Batlle Pichardo, M.D., as principal investigator.
- Dr. Adrian Ebner, Sanatorio Italiano / Hospital Italiano, Asuncion, Paraguay. Named first-in-human press often lists the PI and the hospital and omits a CRO. The hospital intercept is already live. This family adds the PI-query page.
- Clinica de Ojos Orillac-Calvo / Panama Eye Centre, Panama City. ClinicalTrials.gov NCT03193736 (iSTAR Medical MINIject, STAR-I) lists Clinica de ojos Orillac-Calvo, Panama City. The British Journal of Ophthalmology STAR-I paper identifies the same site as Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo.
That is how a sponsor finds a room without finding the operator. Winning the query means answering it as the CRO that already runs first-in-human device files in those countries — not treating the clinic as a rival.
Sourced clinics and investigators only
| Site or investigator (sourced) | City / country | Named public file | What we will not invent | Intercept |
|---|---|---|---|---|
| CODET Vision Institute / Dr. Arturo Chayet | Tijuana, Mexico | CODET clinical-research copy (FIH through commercialization; less than 20 miles from SAN). Opira AIOL NCT04756908 lists Codet Vision Institute, Tijuana. Crystalens and RxSight LAL history on CODET pages. | That CODET, Opira, Crystalens, or RxSight is a bioaccess® client. That flying SAN to TIJ replaces COFEPRIS. | CODET Vision Tijuana FIH |
| Laser Center / Juan F. Batlle Pichardo, M.D. | Santo Domingo, Dominican Republic | GORE GDI EFS NCT05557058, site Laser Center, Santo Domingo; PI named on ICH GCP registry mirrors. | That W. L. Gore is a bioaccess® client. That the site is DIGEMAPS. | Laser Center Santo Domingo FIH |
| Dr. Adrian Ebner (PI query) | Asuncion, Paraguay | Protaryx Dec 2024; Artio Amplifi 2021; NuVera NuVision ICE 2020; Thoratec HeartMate PHP 2013; Vascudyne TRUE graft; Supira pVAD on the bioaccess® program page. | A CRO role on Protaryx, Artio, NuVera, Thoratec, or Vascudyne. The hospital page already covers Supira as the site story. | Adrian Ebner Paraguay FIH · Hospital Italiano Asuncion FIH |
| Clinica de Ojos Orillac-Calvo / Panama Eye Centre | Panama City, Panama | MINIject STAR-I NCT03193736 (iSTAR Medical). | That iSTAR / MINIject is a bioaccess® client. That the clinic is MINSA/CNBI. | Panama Eye Centre MINIject |
That is the clinic-and-PI list. If a program is not on it, we do not invent a building.
El Salvador — country level only
Julio Martinez-Clark’s position, 23 August 2026: ophthalmic clinics exist in El Salvador, and smaller LATAM markets often move fastest for a 5 to 15 patient ophthalmic first-in-human. That sentence is already the thesis of the May 2026 ophthalmic essay. The bioaccess® column does not name a Salvadoran eye clinic. This hub will not invent one.
What we will repeat is already published on clinical trials in El Salvador: Superintendencia de Regulacion Sanitaria (SRS, established August 2024) and Comite Nacional de Etica de la Investigacion en Salud (CNEIS) can run in parallel, with a published 30-60 day startup window; the economy is dollarized; foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not clearance. If a later primary source names a Salvadoran ophthalmic FIH site, we can add a page. Until then, the country system is the honest answer.
Colombia remains on the map. bioaccess® still runs clinical trials in Colombia. Those other markets are options when the device needs them.
Site versus CRO — the table that should sit on every clinic search
| Workstream | What the clinic / hospital (site) typically owns | What the CRO still owns |
|---|---|---|
| Surgical / procedure capability | OR, imaging, implanting physicians, local staff, bilingual front desk | Feasibility against the protocol, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not a hallway conversation with a surgeon, and not a 20-mile drive from SAN | COFEPRIS (Mexico), DIGEMAPS + CONABIOS (Dominican Republic), DINAVISA (Paraguay), MINSA/CNBI (Panama), SRS/CNEIS (El Salvador) |
| Investigational import | Receiving dock, storage if contracted | Importer of record, permits, accountability |
| Quality system | Clinic quality and the case itself | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from the cases they ran | 21 CFR 812.28 eligibility package — not a promise of clearance |
| Country optionality | One building | Colombia and the rest of the bioaccess® platform if the indication needs it |
Going direct to the clinic is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation that a U.S. board expects to survive FDA review.
Four countries, four authorities — same operator layer
Mexico (COFEPRIS). Published on clinical-trials-mexico: COFEPRIS governs device investigations; ethics typically 4-6 weeks; COFEPRIS review typically 4-8 weeks after ethics clearance; combined start-up cited there as 2.8 months, the fastest median in Latin America on that page. Tijuana proximity to SAN is logistics. It is not a COFEPRIS waiver. Intercept: CODET Vision Tijuana FIH.
Dominican Republic (DIGEMAPS / CONABIOS). Published on clinical-trials-dominican-republic: Ministry of Public Health through DIGEMAPS is the national authority; CONABIOS oversees research ethics committees; institutional REC review averages about 30 days; CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Laser Center can run the case. It does not become DIGEMAPS. Intercept: Laser Center Santo Domingo FIH.
Paraguay (DINAVISA). The national sanitary authority for an investigational device is not Dr. Ebner’s inbox. The hospital intercept and the PI intercept split the query: Hospital Italiano Asuncion FIH and Adrian Ebner Paraguay FIH. Supira sits on a live bioaccess® program page. Protaryx, Artio, NuVera, Thoratec, and Vascudyne are named public press. We will not invent a CRO sentence those releases do not contain.
Panama (MINSA / CNBI). Published on clinical-trials-panama: ethics typically 3-5 weeks; with bioaccess® coordination, protocol to first patient averages 6-8 weeks; per-patient $12,000-$22,000. The Panama Clinic intercept remains the large-hospital page. Panama Eye Centre / Orillac-Calvo is the sourced ophthalmic clinic for MINIject STAR-I. Intercept: Panama Eye Centre MINIject.
Why email the PI still leaves the FDA file empty
A principal investigator can tell you whether the anatomy is feasible. That is necessary. It does not produce:
- A regulatory-fit decision — Tijuana is convenient; Santo Domingo is a sourced glaucoma EFS site; Asuncion has a dense cardiovascular FIH press file; Panama is fast and bilingual; El Salvador is a published small-market clock; Colombia still wins on site network and INVIMA Level 4 credibility for some indications. Country choice is a review, not a boarding pass.
- The national application plus insurance.
- Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
- 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. See Can OUS first-in-human data support an FDA IDE submission?.
- A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages — not a clinic we-can-start-next-month hallway number.
bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named clinic.
Do not smear the clinic
CODET Vision Institute, Laser Center Santo Domingo, Dr. Ebner’s cardiovascular service, and Panama Eye Centre / Orillac-Calvo are serious clinical resources. This hub is not a critique of those sites. Use the clinic. Hire the operator.
Colombia is still on the map
A Tijuana, Santo Domingo, or skip-the-CRO search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®.The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract the eye clinic directly?
You can try. A clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by sitting near SAN or by appearing on ClinicalTrials.gov, become your COFEPRIS, DIGEMAPS, DINAVISA, MINSA, or SRS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the clinic as the site.
Which ophthalmic or small-clinic FIH sites can bioaccess® actually name?
On this hub: CODET Vision Institute (Tijuana); Laser Center (Santo Domingo); Dr. Adrian Ebner / Sanatorio Italiano-Hospital Italiano (Asuncion); Clinica de Ojos Orillac-Calvo / Panama Eye Centre (Panama City). El Salvador is country-level only. We will not add an invented Salvadoran clinic, and we will not claim CODET, GORE, iSTAR, Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients.
If I already have the clinic name, what does the CRO still do?
Regulatory-fit and country choice; the national authority packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or another bioaccess® market if one site is not enough. The clinic still does the procedure. Those are different contracts.
Does googling a clinic mean I should avoid that clinic?
No. Do not smear the site. The error is treating the site as the CRO.
Next step
If the search that brought you here was a clinic, start as the operator: contact bioaccess® or book from First-in-Human CRO. Clinic intercepts: CODET Vision Tijuana, Laser Center Santo Domingo, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Hospital pages already live: The Panama Clinic, Hospital Italiano Asuncion, LATAM hospitals vs CRO. Country systems: Mexico, Dominican Republic, Panama, El Salvador, Colombia. Essay: smaller ophthalmic markets.
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