Figures cited from ClinicalTrials.gov NCT06673264 (retrieved 1 September 2026), CEVAXIN public pages, published bioaccess® Panama and case-study pages, and named public press. 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 Panama Clinic, CEVAXIN first-in-human, The Panama Clinic NCT, or “go direct to the site in Panama City,” you followed a facility string ClinicalTrials.gov actually published. Centro de Vacunación e Investigación SA (CEVAXIN) at The Panama Clinic is a real research center inside a real hospital. It is not the operator of the MINSA file.
bioaccess®’s position is simple and it is not adversarial: CEVAXIN is a site (and The Panama Clinic is the building). 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 is not the only fit. Sponsors who skip the CRO and email the research center still have to rebuild that stack. An NCT location row does not become a CRO.
This page is the intercept for that search. It does not clone The Panama Clinic first-in-human (the hospital-name page) or clinical trials in Panama. Those stay the hospital intercept and the country operating system. This page answers the CEVAXIN / NCT query.
Why the NCT site string wins the search — and why that is not a CRO
Device registries write the facility, the city, and the sponsor. They rarely write the CRO. NCT06673264 is the clean public example.
Retrieved 1 September 2026 from ClinicalTrials.gov:
- Brief title: First-In-human Trial of a NovEl Soft and Stretchable Neural probE.
- Official title: FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study.
- Lead sponsor: Axoft, Inc. (INDUSTRY). No collaborator listed. No CRO listed.
- Status: COMPLETED. Actual start 14 March 2025. Actual primary completion and completion 21 August 2025. Last update posted 18 September 2025.
- Design: interventional; phase N/A; single-group; device feasibility; no masking. Actual enrollment 5.
- Intervention, in the registry’s words: device, Soft Neural Probe — sub-acute insertion with neural signal recording during already-scheduled brain-tumor or epileptogenic-tissue resection; 30-day follow-up.
- The only location row: Centro de Vacunación e Investigación SA (CEVAXIN) – The Panama Clinic, Panama City, Panama.
- On that snapshot: no central contacts, no overall officials, no site contacts, no investigators. We will not invent a PI name to fill that blank.
That is useful public information about a completed first-in-human device study at this building. It is also how a founder googles “Panama Clinic neural probe” and lands on a vaccine-research center with no operator on the page.
The same leak exists in trade press that never touches this NCT. Medical Device Network (retrieved 23 August 2026) placed Nanochon’s Chondrograft first-in-human at The Panama Clinic, with named sports-medicine surgeons, MINSA approval, and no CRO in the copy. As of this writing, bioaccess® does not list Nanochon as a client. We cite that press for one reason: this is how a sponsor finds the hospital without finding the operator. We will not add Nanochon to a bioaccess® hospital list.
CEVAXIN is a site. The Panama Clinic is a building. The CRO is the operator.
CEVAXIN’s own about page (retrieved 1 September 2026) describes a medical research center founded in 2013 in Panama. Public claims on that page: more than ten years; +40 clinical studies; +25,000 participants; +15 national and international sponsors; more than 200 research professionals; five Panama sites, including The Panama Clinic, 24 de diciembre, and Chorrera (the same page also lists Avenida México and Chiriquí). The work it advertises is 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.
That is a real vaccine and epidemiology site network. It is not a first-in-human medical-device CRO. Pediatrics, epidemiology, and tropical medicine on a staff page do not become ISO 14155 device monitoring, an investigational-device importer of record, or a 21 CFR 812.28 package because one NCT row hyphenated the legal name onto The Panama Clinic.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing research center or a surgical service in the same building.
- Share institutional ethics-committee calendars and hospital research rules.
- Quote procedure, bed, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- MINSA and CNBI. The national file is not a hallway conversation with a research coordinator, and it is not an NCT location string.
- 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 hospital runs the case. The research center 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-site MSA will not stretch.
Going direct to CEVAXIN or The Panama Clinic 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. The facts a sponsor searching this NCT needs on one screen:
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.
Which first-in-human studies has bioaccess® already run at this building?
Two named programs, already on live case-study pages. We will not add a third hospital-level claim we have not verified on a bioaccess® page. We will not pretend the NCT named the CRO; it did not.
Axoft — ultra-soft BCI at The Panama Clinic
Live case study Axoft — Panama First-in-Human: ultra-soft implantable BCI; FDA Breakthrough Device Designation (2022). With bioaccess®, the FIH ran at The Panama Clinic — four patients implanted during brain-tumor resection — inside a worldwide effort the same page reports as 11 implants, then a $55M Series A in April 2026. Ethics on that page: 4 weeks. bioaccess® ran the regulatory submission, site prep, surgical coordination, and FDA-oriented data collection.
NCT06673264 is the public registry row for that Axoft FINESSE study: completed, actual n=5, location string CEVAXIN–The Panama Clinic, no CRO on the record. Read both sources as they are. The case study is the operator claim. The NCT is the site-direct leak. We will not invent a reconciliation of 4 versus 5 beyond what each page already prints.
Newrotex — world’s first SilkAxons™ implant
Live case study Newrotex — SilkAxons™: investigational silk nerve guide. World-first SilkAxons™ implant at The Panama Clinic through bioaccess®; FIH start August 2025; still investigational; regulatory approval on that page ~2 weeks. bioaccess® found the microsurgery team and ran screening, surgical logistics, implant tracking, and follow-up under ISO 14155-aligned protocols.
The country page also names other Panama work. Those are Panama-country claims, not “at CEVAXIN” claims, so they stay off this list.
What the CRO still does after you have a facility string
Once CEVAXIN–The Panama Clinic is on the slide, the remaining job is the one sponsors skip when they go site-direct:
- Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every indication or every FDA plan. 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 CEVAXIN, The Panama Clinic, or both only if they fit the protocol. A vaccine-research center is not automatically a neurosurgical FIH site.
- 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 site string like this one.
Colombia is still on the map
A Panama Clinic 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 or The Panama Clinic directly?
You can try. A research center can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by appearing on an NCT row, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study, contract the CRO that already ran FIH implants at that building, then let the CRO activate the site.
Does CEVAXIN run device first-in-human studies?
CEVAXIN publishes vaccine, epidemiology, and public-health work. One completed device NCT lists it as the location for Axoft FINESSE. That is a facility string, not a device-CRO product. We do not claim CEVAXIN as a bioaccess® client.
Which FIH studies has bioaccess® already run at The Panama Clinic?
Two on live case-study pages: Axoft and Newrotex. We do not add Nanochon. Nanochon’s public press places Chondrograft at The Panama Clinic; it does not make Nanochon a bioaccess® client.
Next step
If the search that brought you here was CEVAXIN or the NCT location, start as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the hospital intercept on The Panama Clinic first-in-human and the country system on clinical trials in Panama. Named work at this building: Axoft and Newrotex.
CEVAXIN-brand query (no hospital hyphen): CEVAXIN FIH: a vaccine research center is not the device CRO.
Julio G. Martinez-Clark, CEO · bioaccess®