Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Panama country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the NCT facility string “Panama Eye Center” and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Panama Eye Center as a bioaccess® client.
If you searched Panama Eye Center first-in-human, Panama Eye Center CRO, Panama Eye Center clinical trials, or “go direct Panama Eye Center,” you followed the exact location string ClinicalTrials.gov still publishes. Panama Eye Center in Panama City is a real ophthalmic facility string in the public file. It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA device file.
bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns MINSA/CNBI, 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 Panama City 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 intercept for the NCT campus string Panama Eye Center (n=13 DEVICE studies on the 1 September 2026 sweep — the highest new Panama device site after The Panama Clinic / CEVAXIN strings already intercepted). It does not clone the live MINIject / STAR-I intercept Panama Eye Centre / Orillac-Calvo MINIject (CMS 95530). That page is a different query: NCT03193736 STAR-I and the British Journal of Ophthalmology site name. Link it. Do not copy it. Do not invent PIs to reconcile spellings.
Why the campus string wins the search — and why that is not a CRO
Device registries write the implant class, the city, and the facility name. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM DEVICE sweep, Panama Eye Center, Panama City, Panama, is rank 7, n=13, all INDUSTRY-sponsored in that ranking row. Example NCT IDs: NCT03374553, NCT03996200, NCT04517786.
Public snapshots of those three IDs list lead sponsor iSTAR Medical and location facility Panama Eye Center (alongside other countries’ eye hospitals on some records). Brief titles concern MINIject in open-angle glaucoma. That is facility evidence for this NCT string. It is not a reason to republish the STAR-I / Orillac-Calvo page. We will not invent a PI. We will not claim bioaccess® ran these NCTs. No live bioaccess® case-study page names this clinic as a client. iSTAR Medical / MINIject is not claimed as a bioaccess® client here either — the live STAR-I intercept already says the same.
That is the leak: a founder searching “Panama Eye Center clinical trial” finds n=13 device rows without finding MINSA, CNBI, import, insurance, or 21 CFR 812.28. Ranking after TPC/CEVAXIN is a registry fact, not a CRO product.
The site is the site. The CRO is the operator.
A Panama City eye clinic can provide an OR, imaging, and coordinators who have already appeared on industry device 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 ophthalmic service.
- 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 clinic is not built to own for an investigational device:
- MINSA and CNBI. The national device file is not a hallway conversation with a coordinator.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a clinic email. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. The Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
- 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. Eligibility is not clearance. A site MSA does not produce it.
- Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-clinic MSA will not stretch.
Going direct to Panama Eye Center is how you confirm a room. It is not how you open a first-in-human device investigation.
Site versus CRO
| Workstream | What Panama Eye Center (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | OR, imaging, ophthalmic service, local staff | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB, CNBI-registered process |
| National authority | Not the permit holder by appearing on an NCT | MINSA / CNBI |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Clinic 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 Panama City NCT string | Colombia (INVIMA) and the rest of the bioaccess® platform |
How MINSA and CNBI actually work (the short version)
Use the country pages for the full pathway. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI).
Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:
- On clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. Currency is the U.S. dollar.
- On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI often 4–8 weeks; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.
Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship. That is CRO work, not site work.
All bioaccess® Panama protocols 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 clone the STAR-I page — and do not smear the clinic
Panama Eye Center is a serious ophthalmic resource on the public NCT file. This page is not a critique of that work. A cluster of industry glaucoma-device rows is a signal of registry volume, not a substitute for a CRO quality system. Use the site when the protocol fits. Hire the operator.
For STAR-I / Orillac-Calvo / Panama Eye Centre (British spelling) stay on panama-eye-centre-orillac-calvo-miniject. For hospital-named Panama City FIH stay on The Panama Clinic first-in-human. For the vaccine-network brand stay on CEVAXIN FIH. Those are different queries.
What the CRO still does after you have a Panama Eye Center slide
- Regulatory-fit, not tourism. Panama is fast and bilingual. An ophthalmic NCT string is not automatically the right room for every device indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
- Importer of record and device accountability.
- Site activation that is more than a tour. Activate Panama Eye Center only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — eligibility, not a promise of FDA action.
bioaccess® has been active in Panama since the early 2010s. 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 Panama Eye Center directly for a device FIH?
You can try. A clinic can discuss investigator interest, local visit costs, and institutional ethics calendars. It cannot, by appearing as n=13 DEVICE rows, become your MINSA/CNBI 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.
Is this the MINIject / Orillac-Calvo page?
No. That intercept is CMS 95530 for STAR-I (NCT03193736). This page is the NCT campus string “Panama Eye Center” (n=13). Some of those n=13 rows are other iSTAR MINIject listings. Linking is correct. Cloning is not. We do not invent a PI to merge the spellings.
Did bioaccess® run NCT03374553, NCT03996200, or NCT04517786?
No public bioaccess® case-study page says so. We will not invent that claim.
Next step
If the search that brought you here was Panama Eye Center, start as the operator: contact bioaccess® or book from First-in-Human CRO. STAR-I sibling: Panama Eye Centre / Orillac-Calvo MINIject. Hospital: The Panama Clinic first-in-human. Country: clinical trials in Panama.
Julio G. Martinez-Clark, CEO · bioaccess®