Figures cited from CEVAXIN public pages (retrieved 1 September 2026), ClinicalTrials.gov NCT06673264, and published bioaccess® Panama and case-study pages. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the facility, sponsor, and trial those sources support. We do not invent a principal investigator the NCT did not publish. We do not claim CEVAXIN as a bioaccess® client.
If you searched CEVAXIN first-in-human, CEVAXIN CRO, CEVAXIN Panama clinical trials, or “go direct CEVAXIN Panama,” you followed a research-center brand that is genuinely in the public file. Centro de Vacunación e Investigación SA (CEVAXIN) is a real Panama site network. 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: CEVAXIN is a 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 a CEVAXIN room is not the only fit. Sponsors who skip the CRO and email the research center still have to rebuild that stack. A vaccine-trial brand does not become a device CRO because a founder typed “CEVAXIN CRO.”
This page is the CEVAXIN-brand intercept. It does not clone The Panama Clinic first-in-human (the hospital-name page, CMS 95513) or the NCT hyphen page CEVAXIN / The Panama Clinic FIH. Those stay the building query and the registry-string query. This page answers the CEVAXIN-only search.
Why the CEVAXIN name wins the search — and why that is not a CRO
Site marketing writes the studies, the volunteer count, and the MINSA endorsement. It rarely writes a device CRO. CEVAXIN’s own about page (retrieved 1 September 2026) is the clean public example:
- Medical research center founded in 2013 in the Republic of Panama.
- Public claims: more than ten years; +40 clinical studies; +25,000 participants; +15 national and international sponsors; more than 200 research professionals.
- Five Panama sites: The Panama Clinic, 24 de diciembre, Chorrera, and (on the same page) Avenida México and Chiriquí.
- The work it advertises: clinical, epidemiological, and public-health studies of vaccine-preventable disease — polio, dengue, RSV, zoster, norovirus, pneumococcus, hepatitis A, meningitis, pertussis, chikungunya, COVID-19 — under national ethics committees and MINSA endorsement.
- Staff specialties named on that page: pediatrics, epidemiology, pneumology, internal medicine, tropical medicine, health economics.
That copy is useful. It is how a sponsor finds a Panama research center without finding a device operator. It is also how a founder concludes that “CEVAXIN CRO” is the whole first-in-human plan. It is not. MINSA still exists after you have the brand. Pediatrics and vaccine epidemiology on a staff page do not become ISO 14155 device monitoring, an investigational-device importer of record, or a 21 CFR 812.28 package.
This article will not invent a bioaccess® relationship CEVAXIN’s pages do not contain. We do not claim CEVAXIN as a client.
The public device NCT is a location string, not a CRO product
One completed device registry row lists CEVAXIN as a facility. Read it as a location string.
NCT06673264, retrieved 1 September 2026: FINESSE, first-in-human soft neural probe; lead sponsor Axoft, Inc. (INDUSTRY); no collaborator; no CRO; status COMPLETED; actual enrollment 5; actual start 14 March 2025; completion 21 August 2025. The only location row is Centro de Vacunación e Investigación SA (CEVAXIN) – The Panama Clinic, Panama City, Panama. No central contacts, no overall officials, no site investigators on that snapshot. We will not invent a PI name to fill that blank.
That NCT is how a “CEVAXIN first-in-human” search leaks into device FIH. It is not proof that CEVAXIN sells a device-CRO stack. The live bioaccess® case study Axoft — Panama First-in-Human is the operator claim for that building: four patients implanted during brain-tumor resection at The Panama Clinic, ethics ~4 weeks, FDA Breakthrough 2022, $55M Series A April 2026 as cited on that page. The NCT did not name the CRO. We will not pretend it did. We will not invent a reconciliation of 4 versus 5 beyond what each page already prints.
Newrotex — SilkAxons™ is a second live bioaccess® case study at The Panama Clinic (world-first SilkAxons™ implant; FIH start August 2025). That is a hospital-level operator claim. It is not a CEVAXIN-client claim.
CEVAXIN is a site. The CRO is the operator.
A Panama vaccine and epidemiology network can provide rooms, coordinators, volunteer pipelines, and investigators who have run MINSA-endorsed public-health studies. That is necessary for the work they publish. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.
What a research center can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing site.
- 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 center is not built to own for an investigational device:
- MINSA and CNBI. The national device file is not a hallway conversation with a research coordinator.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a site email.
- 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. Foreign data is eligible for FDA submission and review after ISO 14155 / ethics documentation. Eligibility is not clearance, and 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-center MSA will not stretch.
Going direct to CEVAXIN is how you confirm a room. It is not how you open a first-in-human device investigation.
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 research-center 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.
What the CRO still does after you have a CEVAXIN slide
- Regulatory-fit, not tourism. Panama is fast and bilingual. A vaccine site network 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 — see Importer of record for clinical trial devices in Latin America.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate a CEVAXIN site 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. See Can OUS first-in-human data support an FDA IDE submission?.
bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010. That is the operator layer around a research-center brand.
Do not smear the research center
CEVAXIN is a serious vaccine and epidemiology resource. Five named Panama sites and a decade of public-health studies are not a punchline. This page is not a critique of that work. MINSA endorsement of vaccine and epi protocols is a real operating fact. It is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator. For the hospital-named search, stay on The Panama Clinic first-in-human. For the NCT hyphen, stay on CEVAXIN / The Panama Clinic FIH.
Colombia is still on the map
A Panama site-brand 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. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract CEVAXIN directly for a device FIH?
You can try. A research center can discuss investigator interest, local visit costs, and institutional ethics calendars. It cannot, by publishing vaccine-trial volume, become your MINSA/CNBI device applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Is CEVAXIN a CRO?
CEVAXIN publishes itself as a medical research center for clinical, epidemiological, and public-health studies. That is a site network. It is not the First-in-Human CRO for investigational devices. We do not claim CEVAXIN as a bioaccess® client.
Is this the same page as The Panama Clinic first-in-human?
No. That page is the hospital-named intercept (CMS 95513). The NCT hyphen is a separate page. This page is the CEVAXIN-brand intercept.
Next step
If the search that brought you here was CEVAXIN, start as the operator: contact bioaccess® or book from First-in-Human CRO. Hospital: The Panama Clinic first-in-human. NCT hyphen: CEVAXIN / The Panama Clinic FIH. Country: clinical trials in Panama. Named work at The Panama Clinic that is ours: Axoft and Newrotex.
Julio G. Martinez-Clark, CEO · bioaccess®