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Category: Advantages of Conducting Trials in Latin America

Explores the benefits and opportunities of conducting clinical trials in Latin America, including cost-effectiveness and regulatory advantages.

  • University of Sao Paulo: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil 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 ANVISA, CEP, and FDA rules with qualified advisers. We name only the NCT facility string “University of Sao Paulo” and example NCT IDs those sources support. We do not invent InCor, HCFMUSP, or a principal investigator on this page. We do not claim University of Sao Paulo as a bioaccess® client.

    If you searched University of Sao Paulo first-in-human, University of Sao Paulo CRO, USP clinical trials Brazil device, or “go direct University of Sao Paulo,” you followed the exact location string ClinicalTrials.gov still publishes. University of Sao Paulo is a real university. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the campus string is the site label. The First-in-Human CRO still owns ANVISA/CEP, 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 São Paulo is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page answers the registry string University of Sao Paulo only. It does not invent InCor or HCFMUSP as this page’s campus. Heart-institute searches already have a live intercept: InCor HCFMUSP (CMS 95522). Link that page. Do not clone it. “University of Sao Paulo General Hospital” is a different NCT string (DEVICE n=7 on the same sweep) and is not merged here.

    Why the NCT string wins the search — and why that is not a CRO

    Sponsors type what the registry prints. On the 1 September 2026 ClinicalTrials.gov LATAM sweep, the facility string University of Sao Paulo, São Paulo, Brazil, is DEVICE rank 5, n=15, and ALL interventional rank 6, n=73. Example DEVICE NCT IDs: NCT01033084, NCT01149213, NCT01525524.

    Public snapshots of those three IDs list lead sponsor University of Sao Paulo and location facility University of Sao Paulo. Brief titles on those records are transcranial direct current stimulation studies in major depressive disorder, including post-stroke depression. We cite the IDs as facility evidence. We will not invent a PI. We will not claim they are first-in-human device programs bioaccess® ran. We will not stretch them into a heart-institute claim. No live bioaccess® case-study page names this NCT string as a client site.

    That is the leak: a founder searching “University of Sao Paulo clinical trial” or “USP FIH Brazil” finds a campus without finding ANVISA, import, insurance, or 21 CFR 812.28. Ranking n=15 device studies is registry volume, not a CRO product.

    The site is the site. The CRO is the operator.

    A São Paulo university campus can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under this English facility string. 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 university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing lab or clinic.
    • Share institutional CEP calendars and university research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the university is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese). A campus email is not that dossier.
    • CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
    • Investigational import — a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a USP-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
    • The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
    • Multi-country optionality. If São Paulo enrollment or the indication later needs Colombia, Panama, or another campus, a single-university MSA will not stretch.

    Going direct to the University of Sao Paulo NCT string is how you confirm a label. It is not how you open an investigational file.

    Site versus CRO

    Workstream What the USP campus string (site) typically owns What the CRO still owns
    Procedure Rooms, labs, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional CEP calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation dossier (RDC 837/2023)
    Import Receiving and storage if contracted Importer of record
    Quality University 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 NCT spelling in São Paulo Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANVISA and CEP actually work (the short version)

    Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

    • Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
    • Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
    • Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
    • For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
    • Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
    • Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

    All bioaccess® Brazil device 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.

    Sibling heart-institute page — do not merge it here

    If the search you actually meant was Instituto do Coração / HCFMUSP / InCor, stay on incor-hcfmosp-fih. That page already covers public device rows such as Cephea and Leaflex under InCor spellings. This page will not copy those claims onto “University of Sao Paulo.” The Brazil country page already notes that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America as a landscape fact; bioaccess® does not claim to operate that hospital. Dante Pazzanese remains a separate intercept. Do not smear the university.

    What the CRO still does after you have a USP slide

    1. Regulatory-fit, not tourism. Brazil is a sourced device geography. An English NCT campus string is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour. Activate a University of Sao Paulo site only if it fits the protocol — and only the building the protocol actually needs, not a merged InCor identity.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — 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 University of Sao Paulo directly for a device FIH?

    You can try. A university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing as n=15 DEVICE / n=73 ALL on ClinicalTrials.gov, become your ANVISA 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 InCor page?

    No. InCor / HCFMUSP is already live at incor-hcfmosp-fih. This page is the NCT string “University of Sao Paulo” only.

    Did bioaccess® run NCT01033084, NCT01149213, or NCT01525524?

    No public bioaccess® case-study page says so. We will not invent that claim.

    Next step

    If the search that brought you here was University of Sao Paulo, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Heart-institute sibling: InCor HCFMUSP.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital de Clínicas de Porto Alegre: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Brazil 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 ANVISA, CEP, 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 Hospital de Clínicas de Porto Alegre as a bioaccess® client.

    If you searched Hospital de Clínicas de Porto Alegre first-in-human, HCPA clinical trials, Hospital de Clinicas de Porto Alegre CRO, or “go direct HCPA Brazil,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Clínicas de Porto Alegre (HCPA) in Porto Alegre, Rio Grande do Sul, is a real university hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA/CEP, 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 Porto Alegre is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

    This page is one intercept for three registry spellings of the same campus. ClinicalTrials.gov stores them as separate facility strings; we do not. Accented Hospital de Clínicas de Porto Alegre, unaccented Hospital de Clinicas de Porto Alegre, and Hospital de Clinicas e Porto Alegre (HCPA) are one page. It does not clone Fundação Universitaria de Cardiologia Porto Alegre (CMS 95612). That is a different hospital, on a different NCT (Polares MRace / NCT06113354). Linking is correct. Cloning that Polares page is not.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional DEVICE studies; all years; complete dump), this campus sits at the top of named Brazilian device facilities after filters:

    On the same sweep’s ALL interventional ranking (not device-only): accented n=293 (rank 1) and unaccented n=213 (rank 2). 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 not a quality score. They are how a sponsor searching “Porto Alegre hospital clinical trial” lands on a campus without landing on an operator.

    Public snapshots of those example IDs show mixed hospital- and industry-sponsored interventional work. 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 hospital as a client site.

    The site is the site. The CRO is the operator.

    A Porto Alegre university hospital can provide rooms, coordinators, institutional CEP calendars, and investigators who have already appeared on hundreds of 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 hospital can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional CEP calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

    What the hospital is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Porto Alegre is not that dossier.
    • CEP. Institutional ethics under Law 14874. The CEP is tied to the host institution once the site is chosen.
    • Investigational import into Brazil is a separate permit from trial authorization and from later market registration. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent an HCPA-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 Porto Alegre enrollment or the indication later needs São Paulo, Bogotá, or Panama City, a single-hospital MSA will not stretch.

    Going direct to Hospital de Clínicas de Porto Alegre is how you confirm a room. It is not how you open an investigational file.

    Site versus CRO

    Workstream What HCPA (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional CEP calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation dossier (RDC 837/2023)
    Import Receiving and storage if contracted Importer of record
    Quality Hospital 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 Porto Alegre campus (three NCT spellings, one building) Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANVISA and CEP actually work (the short version)

    Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

    • Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
    • Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
    • Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
    • For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
    • Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
    • Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

    All bioaccess® Brazil device 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.

    Do not smear the hospital — and do not merge Porto Alegre buildings

    Hospital de Clínicas de Porto Alegre is a serious academic resource. Ranking first on a public DEVICE facility list is a signal of registry volume, not a punchline. This page is not a critique of that work. Volume on ClinicalTrials.gov is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.

    Do not merge this campus into Fundação Universitaria de Cardiologia. Do not merge it into São Paulo intercepts already live: InCor HCFMUSP and Instituto Dante Pazzanese. Different buildings. Different queries.

    What the CRO still does after you have an HCPA slide

    1. Regulatory-fit, not tourism. Brazil is a sourced device geography. One Porto Alegre campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA/CEP packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate HCPA only if it fits the protocol.
    5. 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 Hospital de Clínicas de Porto Alegre directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by ranking high on ClinicalTrials.gov, become your ANVISA 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 hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry n=30+26+5 (DEVICE) and n=293+213 (ALL) are ClinicalTrials.gov counts, not bioaccess® enrollment.

    Is this the same hospital as Fundação Universitaria de Cardiologia?

    No. Fundação Universitaria de Cardiologia is a different Porto Alegre facility already intercepted for Polares MRace (NCT06113354). This page is the HCPA campus-string intercept.

    If I already have HCPA, what does the CRO still do?

    Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design); the ANVISA/CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.

    Next step

    If the search that brought you here was Hospital de Clínicas de Porto Alegre or HCPA, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Other Porto Alegre hospital: Fundação Universitaria de Cardiologia.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CEVAXIN FIH: A Vaccine Research Center Is Not the Device CRO

    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

    1. 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.
    2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. 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.
    5. 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®

  • CEVAXIN / The Panama Clinic FIH: The NCT Site String Is Not the MINSA File

    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:

    1. 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.
    2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. 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.
    5. 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®

  • Fundação Universitaria de Cardiologia Porto Alegre: Polares MRace EFS Site, Not the ANVISA File

    Figures cited from the live ClinicalTrials.gov record NCT06113354 (last update posted 1 September 2026; first posted 2 November 2023) and the published bioaccess® Brazil country page, verified 1 September 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the facility, investigators, and trial those sources support. Polares Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

    If you searched Fundação Universitaria de Cardiologia clinical trial, Porto Alegre MRace, Polares Medical Brazil EFS, EXPLORE MRace BR, or “go direct to the Porto Alegre mitral site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Fundação Universitaria de Cardiologia in Porto Alegre, Rio Grande do Sul, is a real cardiology facility on that record. It is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: Fundação Universitaria de Cardiologia is the site. The First-in-Human CRO still owns ANVISA / CEP, 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 Porto Alegre is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A recruiting location row does not become a CRO.

    This page is the intercept for the Porto Alegre query. It does not clone clinical trials in Brazil. That page stays the country operating system. The São Paulo sister row on the same NCT already has its own intercept: InCor HCFMUSP. Do not merge Porto Alegre into InCor. PercAssist AVANXA remains a separate city-plus-KOL intercept with no hospital invented: PercAssist AVANXA Brazil.

    Why the hospital name wins the search — and why that is not a CRO

    NCT06113354 is an industry device early-feasibility listing. Brief title: EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant. Official title: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant Brazil (EXPLORE MRace – BR). Acronym: EXPLORE MRace. Lead sponsor: Polares Medical SA, class INDUSTRY. Collaborator listed: Polares Medical, Inc. only. No CRO is listed.

    Design on the 1 September 2026 snapshot: interventional; single-group registry; no masking; primary purpose DEVICE_FEASIBILITY; phase N/A; estimated enrollment 10; status RECRUITING. Actual start 8 April 2024. Study first posted 2 November 2023; last update posted 1 September 2026. Condition: mitral valve disease. Intervention, in the registry’s words: Transcatheter mitral valve repair (MRace Implant and Delivery System), other name TMVr — femoral-vein / transseptal placement of a prosthesis intended to augment the posterior mitral leaflet.

    Location rows currently published:

    • Fundação Universitaria de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil — RECRUITING. Site contact named as Rogerio Leite, MD. Principal investigator listed as Roberio Leite, MD (names as published on ClinicalTrials.gov; we will not invent a single merged identity or invent a hospital email beyond what the public row shows).
    • InCor – Instituto do Coração do Hospital das Clínicas da FMUSP, São Paulo, Brazil — RECRUITING. Principal investigators / contacts named include Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD. Already intercepted on incor-hcfmosp-fih.

    Central contact on the record: Kristine Orosz, Polares Medical. Study director: Robin Eckert, Polares Medical. The brief summary still says “up to 10 patients at one (1) center in Brazil,” while the locations module lists two recruiting Brazilian facilities. We report both facts as published. We do not invent which building ran which case.

    Read the record as it is. Primary purpose is DEVICE_FEASIBILITY and the title says Early Feasibility. Estimated n=10 is classic EFS scale. No CRO collaborator appears. That is the site-direct leak: a sponsor searching MRace, Polares, or Porto Alegre cardiology now lands on a named hospital with InCor already known and Fundação Universitaria still without a dedicated public intercept until this page.

    Porto Alegre is a site. The CRO is the operator.

    A Porto Alegre cardiology foundation can provide imaging, structural-heart rooms, and an investigator the registry already named. That is necessary. It is not sufficient for an early-feasibility TMVr study a U.S. board expects to survive FDA review — including a later IDE conversation after OUS feasibility.

    What a site can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and procedural feasibility for a mitral protocol — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional CEP calendars and hospital research rules.
    • Quote procedure, visit, and local staffing costs for the cases they will physically run.

    What the site is not built to own for an investigational device:

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Porto Alegre is not that dossier.
    • CEP. Institutional ethics under Law 14874; published country-page cap of 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have Fundação Universitaria” still leaves the packet to write.
    • Investigational import into Brazil is a separate permit from the trial authorization and from later ANVISA market registration (RDC 751/2022 / BRH). See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a Porto Alegre-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including if you later use the InCor row on the same NCT or add Colombia.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance. See OUS FIH and FDA IDE.
    • Multi-country optionality. If Porto Alegre enrollment, imaging, or the indication later needs São Paulo capacity already on this NCT, Bogotá, or Panama City, a single-hospital MSA will not stretch.

    Going direct to Fundação Universitaria de Cardiologia is how you confirm a room. It is not how you open an investigational file.

    Site versus CRO

    Workstream What Fundação Universitaria (site) typically owns What the CRO still owns
    Procedure OR / hybrid room, imaging, mitral caseload, local staff Protocol fit, training, MRace-class device accountability
    Ethics Institutional CEP calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by being listed on an NCT ANVISA clinical-investigation dossier (RDC 837/2023)
    Import Receiving and storage if contracted Importer of record
    Quality Hospital 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 Porto Alegre building (plus InCor on the same NCT) Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANVISA and CEP sit next to the hospital

    Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:

    • Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837.
    • Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
    • Trial authorization and market registration are separate workstreams.
    • Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval.
    • bioaccess®’s published Brazil cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study. Headline ~40% faster / ~30% lower per-patient figures on llms.txt and LATAM FIH benchmarks 2026 are the same class of estimate.

    We will not invent a Fundação Universitaria-only day-count. Ask for a protocol-specific calendar. A hospital email is not an ANVISA approval.

    What the Polares public file actually supports — and what it does not

    • Device: MRace Implant and Delivery System (TMVr / posterior leaflet restoration), as described on NCT06113354.
    • Sponsor: Polares Medical SA (industry). Collaborator: Polares Medical, Inc. No CRO named.
    • Sites: Fundação Universitaria de Cardiologia, Porto Alegre (this page); InCor HCFMUSP, São Paulo (existing intercept).
    • Design: interventional DEVICE_FEASIBILITY early feasibility; estimated n=10; actual start 8 April 2024; RECRUITING on the 1 September 2026 last-update snapshot.
    • Named investigators (as published): Rogerio Leite, MD (Porto Alegre contact); Roberio Leite, MD (Porto Alegre PI listing); Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD (InCor).
    • Not claimed here: that the NCT named bioaccess®; that Polares Medical is a bioaccess® client; that we have Polares outcomes; that the brief summary’s “one center” line erases the second location row; that Porto Alegre is the same building as InCor, Dante Pazzanese, or PercAssist AVANXA.

    Sister São Paulo intercepts stay on their own buildings: InCor and Instituto Dante Pazzanese. Do not merge them into Porto Alegre.

    What the CRO still does after you have a hospital name

    • Regulatory-fit, not tourism. Brazil is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
    • Protocol, IB, ICF, insurance, and the ANVISA / CEP packet.
    • Importer of record and device accountability across Porto Alegre and, if used, the InCor row.
    • ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
    • Optionality if one Rio Grande do Sul room is not enough.

    The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Fundação Universitaria de Cardiologia directly?

    You can try. The facility can discuss investigator interest, local procedure costs, and CEP calendars. It cannot become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Polares listed Porto Alegre. Contract the CRO; let the CRO activate the site.

    Did bioaccess® run EXPLORE MRace / Polares in Brazil?

    No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.

    InCor is on the same NCT. Why a separate Porto Alegre page?

    Because sponsors search the facility string they see. InCor already has incor-hcfmosp-fih. Fundação Universitaria de Cardiologia is a different building in a different city. Linking is correct. Duplicating the InCor slug is not.

    If I already have Porto Alegre, what does the CRO still do?

    Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design that already includes InCor on this NCT); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.

    Is Colombia still an option?

    Yes. bioaccess® still runs trials in Colombia. A Porto Alegre EFS search is not an instruction to abandon INVIMA.

  • Panama Eye Centre / Orillac-Calvo MINIject: STAR-I Site and the CRO That Owns MINSA

    Figures cited from ClinicalTrials.gov NCT03193736, the British Journal of Ophthalmology STAR-I paper, published bioaccess® Panama pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the clinic and trial those sources support. We do not claim iSTAR Medical or MINIject as a bioaccess® client.

    If you searched Panama Eye Centre clinical trial, Orillac-Calvo MINIject, STAR-I Panama, or go direct to the eye clinic in Panama, you are following a clinic name that is genuinely in the public file. Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a real ophthalmic research site in Panama City. It is not the operator of the MINSA / CNBI file.

    bioaccess®’s position is simple and it is not adversarial: Panama Eye Centre 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 is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A STAR-I listing does not become a CRO.

    This page is the intercept for the ophthalmic-clinic query. It does not clone clinical trials in Panama, the March 2026 Panama essay, or The Panama Clinic first-in-human. Those pages stay the country system and the large-hospital intercept (Axoft, Newrotex). This page answers the Orillac-Calvo / Panama Eye Centre search.

    Why the clinic name wins the search — and why that is not a CRO

    Device registries and journals write the implant, the city, and the site. They rarely write the CRO. MINIject STAR-I is the clean public example for this Panama City eye clinic.

    NCT03193736 (STAR-I), retrieved 23 August 2026: official title is a prospective, open, multicenter clinical trial with one cohort analysing the efficacy and safety of MINIject in patients with open-angle glaucoma uncontrolled by topical hypotensive medications. Lead sponsor: iSTAR Medical. Status: completed. Start 19 June 2017; primary completion 16 April 2018; completion 25 November 2019. Locations listed: Maxivision Eye Hospital, Hyderabad, India, and Clinica de ojos Orillac-Calvo, Panama City, Panama.

    The British Journal of Ophthalmology two-year STAR-I paper (trial registration NCT03193736) identifies the Panama site as Panama Eye Centre (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama, and states IRB approval was obtained from that hospital (and from Maxivision). The paper reports a prospective, multicentre, first-in-human, single-arm study of stand-alone MINIject implantation in 25 patients; implants between June and October 2017 by three surgeons in Panama and India; two-year follow-up for 21 patients. We cite the published outcomes as journal facts, not as a bioaccess® result: mean IOP 23.2 to 13.8 mmHg at two years (-40.7 percent) on fewer medications, as the paper states. We will not add a PI name the registry listing we retrieved did not put in the site row.

    That file is useful public information about a site-named Panama ophthalmic FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list iSTAR Medical as a client on our published pages, and this article will not invent that relationship.

    Panama Eye Centre is a site. The CRO is the operator.

    A Panama City eye clinic can provide the OR, imaging, and surgeons who have already taken a supraciliary micro-invasive glaucoma device through a published first-in-human cohort. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

    What a site can typically do when a sponsor goes direct:

    • Discuss investigator interest and surgical feasibility — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and clinic research rules.
    • Quote procedure 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. Panama’s Ministry of Health, through the Dirección Nacional de Farmacia y Drogas, is the national health authority. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). A hallway conversation with a surgeon is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a PI email.
    • Clinical trial insurance. Required. Our 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 clinic runs the case. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If Panama enrollment or the indication later needs Colombia, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

    Going direct to Panama Eye Centre is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How MINSA and CNBI sit next to the clinic

    Use the country pages for the full pathway. 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. A 10-patient FIH is described as typically $200K-$300K. Currency is the U.S. dollar.
    • On the March 2026 blog: early-feasibility is ethics-committee-driven; 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. 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 STAR-I public file actually supports — and what it does not

    • Device: MINIject (iSTAR Medical), STAR-I, NCT03193736.
    • Panama site: Clinica de ojos Orillac-Calvo on ClinicalTrials.gov; Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo, in the BJO paper.
    • Design: prospective, multicentre, first-in-human, single-arm; 25 implanted; Panama and India; completed 2019 on the registry.
    • Not claimed here: that iSTAR retained bioaccess®; that this clinic is The Panama Clinic; that Axoft or Newrotex ran here; that we have a named PI on this intercept beyond the three-surgeon statement in the journal (PD, CH, IKA) — we will not guess local identities those initials do not prove.

    What the CRO still does after you have a clinic name

    1. Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates FIH device studies as a multi-country platform. That is the operator layer around a named Panama City eye clinic.

    Do not smear the clinic

    Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a serious ophthalmic resource. This page is not a critique of the site. A published STAR-I cohort is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator. If the hospital you actually typed was The Panama Clinic, use that intercept instead of stretching 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 (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Panama Eye Centre / the site bioaccess® / the CRO
    Procedure OR, imaging, glaucoma service Protocol fit, training, device accountability
    Ethics Institutional committee calendar Packet, ICF, IB, CNBI-registered process
    National authority Not the permit holder by appearing on STAR-I MINSA / CNBI
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One building in Panama City Colombia (INVIMA) still on the platform

    Frequently asked questions

    Can I contract Panama Eye Centre or Orillac-Calvo directly?

    You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT03193736, become your MINSA/CNBI 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 if it is the right site for your protocol.

    Is this the same as The Panama Clinic?

    No. The Panama Clinic intercept covers Axoft and Newrotex via bioaccess® and Nanochon in independent press. This page is the sourced ophthalmic clinic for MINIject STAR-I. Do not merge the buildings.

    What does the CRO still do if the clinic is already identified?

    Regulatory-fit and country choice; the MINSA and CNBI 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 if Panama is not enough. The clinic still does the procedure.

    Did bioaccess® run STAR-I?

    We do not claim that. iSTAR Medical is the sponsor on the registry. This intercept exists because sponsors search the site name. It is not a STAR-I case study.

    Next step

    If the search that brought you here was Orillac-Calvo, Panama Eye Centre, or MINIject Panama, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Hospital: The Panama Clinic. Country: Panama, Colombia. Other clinics: CODET, Laser Center, Adrian Ebner.

  • Laser Center Santo Domingo FIH: GORE GDI Site and the CRO That Owns DIGEMAPS

    Figures cited from ClinicalTrials.gov NCT05557058, ICH GCP registry mirrors, published bioaccess® Dominican Republic pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the clinic, investigator, and trial those sources support. We do not claim W. L. Gore and Associates as a bioaccess® client.

    If you searched Laser Center Santo Domingo clinical trial, Juan Batlle GORE glaucoma, Dominican Republic first-in-human ophthalmic, or go direct to the site in Santo Domingo, you are following a clinic name that is genuinely in the public file. Laser Center in Santo Domingo is a real ophthalmic research site. It is not the operator of the DIGEMAPS file.

    bioaccess®’s position is simple and it is not adversarial: Laser Center is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package plus the option to add Colombia, Panama, Mexico, or El Salvador if the Dominican Republic is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A ClinicalTrials.gov row does not become a CRO.

    This page is the intercept for that search. It does not clone clinical trials in the Dominican Republic or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

    Why the clinic name wins the search — and why that is not a CRO

    Device registries write the implant, the city, the site, and sometimes the PI. They rarely write the CRO. The GORE Glaucoma Drainage Implant early feasibility study is the clean public example for Santo Domingo.

    NCT05557058, retrieved 23 August 2026: official title is a prospective, single-center, early feasibility clinical study designed to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in subjects with primary open-angle glaucoma. Lead sponsor: W. L. Gore and Associates. Status: active, not recruiting. Start date 14 September 2022. Estimated enrollment 30. Design: interventional, randomized parallel arms for High and Low device configurations plus a non-randomized Modified configuration. Primary effectiveness listed on the registry: proportion of treated eyes with at least a 20 percent decrease in mean diurnal IOP at 6 months while maintaining the same or fewer hypotensive medications as at baseline. Single listed location: Laser Center, Santo Domingo, Dominican Republic.

    ICH GCP registry mirrors of the same NCT list the principal investigator as Juan F. Batlle Pichardo, M.D., Laser Center. That is useful public information about a site-named Dominican ophthalmic EFS. It is not a bioaccess® case study. As of this writing, bioaccess® does not list W. L. Gore as a client on our published pages, and this article will not invent that relationship.

    That listing is how a sponsor finds Laser Center without finding the operator. Winning the query means answering it as the CRO that already publishes Dominican Republic first-in-human device operations and still runs the rest of the Latin American platform.

    Laser Center is a site. The CRO is the operator.

    A Santo Domingo ophthalmic center can provide the OR, imaging, and an investigator who is already named on a public early-feasibility glaucoma implant listing. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

    What a site can typically do when a sponsor goes direct:

    • Discuss investigator interest and surgical feasibility with a service such as Dr. Batlle Pichardo when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and clinic research rules.
    • Quote procedure and local staffing costs for the cases they will physically run.

    What the site is not built to own for an investigational device:

    • DIGEMAPS. The Ministry of Public Health, through the Directorate General of Medicines, Food and Health Products, is the national authority. A hallway conversation with a surgeon is not that file.
    • CONABIOS-overseen ethics. Institutional REC review and CONABIOS-level review are country-system work, already described on the Dominican Republic page.
    • Investigational import. Ethics letter, investigator brochure, and an importation permit — end-to-end work, not a PI email.
    • Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santo Domingo-only number here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. 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 as that rule defines it. Eligibility is not clearance.
    • Multi-country optionality. If Dominican enrollment or the indication later needs Colombia or Panama, a single-clinic MSA will not stretch.

    Going direct to Laser Center is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How DIGEMAPS and CONABIOS sit next to the clinic

    Use the country page for the full pathway. Facts a sponsor searching this clinic needs on one screen, already published on clinical-trials-dominican-republic:

    The Ministry of Public Health through DIGEMAPS is the national regulatory authority. Ethics oversight is coordinated by CONABIOS, which supervises Research Ethics Committees. Institutional REC review averages about 30 days. CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Protocols follow the Declaration of Helsinki and CIOMS guidelines. bioaccess® prepares dossiers and coordinates with DIGEMAPS through start-up. Foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not a promise of clearance, when the study is run under ISO 14155 with proper authorization and ethics approval.

    We will not invent a Laser Center-only day-count. Ask for a protocol-specific calendar. A surgeon email is not a DIGEMAPS approval.

    What the GORE public file actually supports — and what it does not

    • Device: GORE Glaucoma Drainage Implant, several configurations (registry).
    • Site: Laser Center, Santo Domingo, Dominican Republic (NCT05557058 locations).
    • PI on registry mirrors: Juan F. Batlle Pichardo, M.D., Laser Center.
    • Design: prospective, single-center, early feasibility; estimated n=30; start 14 September 2022; active, not recruiting on the 23 August 2026 snapshot.
    • Not claimed here: that the NCT named bioaccess®; that Laser Center is the only ophthalmic site in the Dominican Republic; that we have GORE outcomes; that Centro Laser marketing copy is the same as a first-in-human quality system.

    What the CRO still does after you have a clinic name

    1. Regulatory-fit, not tourism. The Dominican Republic is a sourced ophthalmic EFS geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    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 Santo Domingo site.

    Do not smear the clinic

    Laser Center and Dr. Batlle Pichardo are serious ophthalmic resources. This page is not a critique of the site. A public EFS listing is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

    Colombia is still on the map

    A Santo Domingo 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® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Laser Center / the site bioaccess® / the CRO
    Procedure OR, imaging, glaucoma service, PI Protocol fit, training, device accountability
    Ethics Institutional REC calendar Packet, ICF, IB, CONABIOS coordination
    National authority Not the permit holder by being listed on an NCT DIGEMAPS
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One building in Santo Domingo Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

    Frequently asked questions

    Can I contract Laser Center Santo Domingo directly?

    You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT05557058, become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Laser Center as the site if it is the right site for your protocol.

    Who is the PI on the GORE GDI listing?

    Juan F. Batlle Pichardo, M.D., Laser Center, as stated on ICH GCP mirrors of NCT05557058. That fact does not make the PI your CRO.

    What does the CRO still do if the clinic is already identified?

    Regulatory-fit and country choice; the DIGEMAPS and CONABIOS 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 Panama if Santo Domingo is not enough. The clinic still does the procedure.

    Is an early feasibility study the same as a commercial first implant in LATAM?

    No. NCT05557058 is an investigational early feasibility program. A commercial first implant is launch activity. Do not mix the two when you brief a board.

    Next step

    If the search that brought you here was Laser Center or Juan Batlle, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: CODET Vision Tijuana, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country: Dominican Republic, Colombia, Panama.

  • Adrian Ebner Paraguay FIH: The PI Search and the CRO That Owns DINAVISA

    Figures cited from named public press, the live Hospital Italiano Asuncion intercept, the bioaccess® Supira program page, and DINAVISA-related country copy, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the PI, hospital aliases, and trials those sources support. We do not claim Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients. Supira is cited from a live bioaccess® page; we do not invent a CRO sentence the 2022 sponsor release does not contain.

    If you searched Adrian Ebner first-in-human, Adrián Ebner Paraguay clinical trial, Sanatorio Italiano Asuncion FIH, or go direct to the PI in Paraguay, you are following an investigator name that is genuinely in the public file. Dr. Adrián Ebner, Head of Cardiovascular at Sanatorio Italiano / Hospital Italiano / Italian Hospital, Asunción, is a real first-in-human cardiovascular investigator. He is not the operator of the DINAVISA file.

    bioaccess®’s position is simple and it is not adversarial: Dr. Ebner and the Italian Hospital are the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or Panama if Asunción is not the only fit. Sponsors who skip the CRO and email the PI still have to rebuild that stack. A press release that names the surgeon does not make the surgeon a CRO.

    This page is the PI-query intercept. The hospital-query intercept is already live at Hospital Italiano Asunción FIH. The program narrative stays at Supira Medical first-in-human trial, Paraguay. Do not treat this page as a second hospital essay. It answers the investigator-named search.

    Why the PI name wins the search — and why that is not a CRO

    Device press writes the implant, the city, and the surgeon. It rarely writes the CRO. Dr. Ebner is a repeated public example of that pattern. The hospital names in those releases vary — Sanatorio Italiano, Hospital Italiano, Italian Hospital Asunción — and we will use the alias each source used rather than collapsing them into a name we invented.

    Named first-in-human press we will stand behind (verified 23 August 2026), with the CRO rule stated once so it is not missed:

    • Protaryx transseptal puncture — December 2024. Cardiac Rhythm News reports completion of a first-in-human study on 3 December 2024 at Sanatorio Italiano de Asunción; five patients; ethics approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies; procedures by Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital, with guidance by Gagan Singh (UC Davis). The release discusses 510(k) intent. Not a bioaccess® client claim.
    • Artio Amplifi vein dilation system — 2021. Interventional News reports Artio completed enrolment of a first-in-human study; five patients treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción. Not a bioaccess® client claim.
    • NuVera NuVision ICE catheter — July 2020. PR Newswire (6 July 2020) and Cardiac Rhythm News: first-in-human use; first participant treated for an atrial septal defect by PI Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asunción, with remote live-feed support from the NuVera team in the U.S. Not a bioaccess® client claim.
    • Thoratec HeartMate PHP — 2013. DAIC (28 March 2013): first human use of HeartMate PHP during high-risk PCI; procedures by Adrian Ebner, M.D., at Sanatorio Italiano in Asunción; chief of the Cardiovascular Department. Not a bioaccess® client claim.
    • Vascudyne TRUE Vascular Graft. Company / OTS release: first-in-human use for hemodialysis access; first procedures by Adrian Ebner, MD, Director of Endovascular and Cardiovascular Surgery at Sanatorio Italiano in Asunción, as part of an early feasibility study; five patients in that announcement. Later literature lists Ebner among authors of a first-in-human evaluation of the TRUE AVC conduit. Not a bioaccess® client claim.
    • Supira pVAD — September 2022. Sponsor release (16 September 2022) names PI Adrian Ebner at the Italian Hospital Asunción. The live bioaccess® program page places the same FIH at that hospital and reports later South American experience, Breakthrough designation, U.S. EFS (November 2024), and SUPPORT II (April 2026) as published there. We cite the bioaccess® page. We do not invent a CRO sentence the 2022 sponsor copy does not contain.

    That list is how a sponsor finds Dr. Ebner without finding the operator. It is also how a founder concludes that emailing the PI is the whole first-in-human plan. It is not. DINAVISA still exists after you have the name.

    The PI is a site. The CRO is the operator.

    An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has taken several public first-in-human devices through first cases, sometimes with visiting or remote U.S. advisors. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

    What a PI / hospital can typically do when a sponsor goes direct:

    • Discuss investigator interest and procedural feasibility — when that service is available and appropriate for your device, which is not automatic.
    • 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 PI is not built to own for an investigational device:

    • DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs. A hallway conversation with a surgeon is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
    • Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent an Asunción-only number here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Eligibility is not clearance. Supira’s later U.S. EFS and SUPPORT II path, as published on the bioaccess® page, is exactly why the early Latin American dataset has to be built as a file, not as a souvenir implant.
    • Multi-country optionality. If Paraguay enrollment or the indication later needs Colombia or Panama, a single-PI MSA will not stretch.

    Going direct to Dr. Ebner is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How DINAVISA sits next to the PI (the short version)

    The hospital intercept already states this. We repeat it here because the PI query is a different Google, not a different file.

    DINAVISA is the national sanitary authority. Ethics sits with the institutional committee — Protaryx press, for example, names the Research Ethics Committee of the Paraguayan Institute of Social Studies for that study. Import sits on a permit. Monitoring sits on ISO 14155. Those layers are why a CRO exists after you already know Dr. Ebner’s name.

    We will not invent a median DINAVISA day-count. The clocks we will repeat are already published elsewhere on bioaccessla.com and are country-specific, not PI-specific: Panama ethics 3-5 weeks and 6-8 weeks to first patient with bioaccess® coordination on clinical-trials-panama; Colombia ethics 4-6 weeks and per-patient $15,000-$25,000 on that same comparison. Ask for a Paraguay protocol-specific calendar.

    All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA 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 PI name

    1. Regulatory-fit, not tourism. Paraguay has a dense public cardiovascular FIH press file at this investigator. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama.
    2. Protocol, IB, ICF, insurance, and the DINAVISA packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    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 Asunción PI.

    Do not smear the investigator

    Dr. Ebner’s cardiovascular service and Sanatorio Italiano / Hospital Italiano Asunción are serious clinical resources. This page is not a critique of the PI. Visiting or remote U.S. advisors in the public releases are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the site. Hire the operator. For the hospital-named search, stay on Hospital Italiano Asunción FIH.

    Colombia is still on the map

    A Paraguay PI 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® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Dr. Ebner / the site bioaccess® / the CRO
    Procedure Cath lab, imaging, CV department, PI Protocol fit, training, device accountability
    Ethics Institutional committee calendar Packet, ICF, IB, deficiency responses
    National authority Not the permit holder by being named in press DINAVISA
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One service in Asunción Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

    Frequently asked questions

    Can I contract Dr. Ebner or Sanatorio Italiano directly?

    You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Protaryx, Artio, NuVera, Thoratec, Vascudyne, or Supira press, become your DINAVISA 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.

    Which of these programs is on a bioaccess® page?

    Supira pVAD is on the live bioaccess® Paraguay program page and on the Hospital Italiano intercept. Protaryx, Artio Amplifi, NuVera NuVision ICE, Thoratec HeartMate PHP, and Vascudyne TRUE graft are named public press. We will not invent a CRO role on those five.

    What does the CRO still do if the PI is already identified?

    Regulatory-fit and country choice; the DINAVISA and ethics 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 Panama if Asunción is not enough. The hospital still does the procedure.

    Is this the same page as Hospital Italiano Asunción FIH?

    No. That page is the hospital-named intercept, centered on the Supira public file. This page is the PI-named intercept and lists the broader press file without converting those sponsors into clients.

    Next step

    If the search that brought you here was Adrian Ebner or Sanatorio Italiano, start as the operator: contact bioaccess®. Hospital page: Hospital Italiano Asunción FIH. Program: Supira Paraguay. Clinic hub: ophthalmic FIH clinics vs CRO. Hospital hub: LATAM hospitals vs CRO. Country: Colombia, Panama.

  • Ophthalmic FIH Clinics in LATAM vs the CRO: CODET, Laser Center, Ebner, Panama Eye

    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.

  • CODET Vision Institute Tijuana FIH: The Site 20 Miles from SAN and the CRO That Owns COFEPRIS

    Figures cited from CODET Vision Institute public pages, ClinicalTrials.gov NCT04756908, published bioaccess® Mexico pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS and FDA rules with qualified advisers. We name only the clinic, investigator, and trials those sources support. We do not claim CODET, Opira, Crystalens, or RxSight as bioaccess® clients.

    If you searched CODET Vision Institute clinical trials, Arturo Chayet first-in-human, Tijuana ophthalmic FIH, or fly to Tijuana and skip the CRO, you are following a clinic name that is genuinely in the public file. CODET Vision Institute in Tijuana is a real ophthalmic research site. It is not the operator of the COFEPRIS file.

    bioaccess®’s position is simple and it is not adversarial: CODET is the site. The First-in-Human CRO still owns COFEPRIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, the Dominican Republic, or El Salvador if Tijuana is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A 20-mile drive from San Diego International Airport does not become a CRO.

    This page is the intercept for that search. It does not clone clinical trials in Mexico or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

    Why the clinic name wins the search — and why that is not a CRO

    Clinic marketing writes the implant, the city, the founder, and the airport. It rarely writes the CRO. CODET’s own clinical-research page (retrieved 23 August 2026) is the clean public example for Tijuana:

    • Ophthalmologists work with industry from start to finish: from first-in-human through commercialization and beyond.
    • The institute is located less than 20 miles south of San Diego International Airport and not more than 100 miles from Orange County.
    • Dr. Arturo Chayet has been a clinical-trial investigator and consultant to ophthalmic industry since 1994, with work in refractive surgery, cataract, and intraocular lenses. CODET states he is typically the first surgeon to test new technologies for early-stage vision-care companies.

    That copy is useful. It is how a U.S. sponsor finds CODET without finding an operator. The same page is also how a founder concludes that flying SAN to Tijuana is the whole first-in-human plan. It is not. COFEPRIS still exists on the Mexican side of that 20-mile drive.

    This article will not invent a bioaccess® relationship CODET’s pages do not contain. It will say what is true now: if you are googling this clinic for a new ophthalmic first-in-human device study, the CRO you want is the one that already publishes Mexico device operations and still runs the rest of the Latin American platform — including Colombia.

    What the public CODET file actually supports — and what it does not

    • Site: CODET Vision Institute, Tijuana, Mexico (codetvision.com/clinical-research).
    • Investigator: Dr. Arturo Chayet, founder, named on CODET doctor and research pages (doctor page).
    • Opira AIOL: ClinicalTrials.gov NCT04756908 — Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, a commercial multifocal IOL, and a commercial monofocal IOL. Sponsor FSV6, Ltd. Locations listed include Codet Vision Institute, Tijuana, Mexico (and Clinica 2020, San Jose, Costa Rica). Status on the registry snapshot we retrieved: unknown / recruiting on mirrors. We report the listing, not a result.
    • Crystalens: CODET cataract pages state that in 1999 Dr. Chayet conducted the first clinical trial on accommodating IOLs for Ionics (now Bausch + Lomb) and that he was instrumental in developing Crystalens, described there as the first FDA-approved accommodating IOL.
    • RxSight Light Adjustable Lens: CODET LAL and research pages state a 2002-2024 Calhoun Vision / RxSight collaboration, first LAL surgery in the world at CODET in 2002, 600+ clinical-trial LAL procedures before public availability, and FDA Phase III completion as claimed on CODET’s research page. ClinicalTrials.gov NCT04529616 lists CODET Vision Institute, Tijuana as the Mexico site for an RxSight LAL / LDD exploratory study.
    • Not claimed here: that Opira, Crystalens, RxSight, Calhoun, Ionics, or CODET retained bioaccess®; that Tijuana is outside COFEPRIS; that every CODET commercial procedure is an investigational FIH; that Ocumetics Mexico City work ran at CODET (the Ocumetics bioaccess® page is Mexico City / country-level, not a CODET claim).

    CODET is a site. The CRO is the operator.

    A Tijuana ophthalmic institute can provide the OR, imaging, a bilingual staff, and an investigator who has taken accommodating IOLs and a light-adjustable lens through long public histories. 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 a site can typically do when a sponsor goes direct:

    • Discuss investigator interest and surgical feasibility with a service such as Dr. Chayet’s — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and clinic research rules.
    • Quote procedure and local staffing costs for the cases they will physically run.
    • Host a same-day visit after a SAN landing. That is logistics, not a national file.

    What the site is not built to own for an investigational device:

    • COFEPRIS. Mexico’s Comision Federal para la Proteccion contra Riesgos Sanitarios is the national health authority for a device investigation. A hallway conversation in Tijuana is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
    • Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Tijuana-only number here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. 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 as that rule defines it. Eligibility is not clearance.
    • Multi-country optionality. If Tijuana enrollment or the indication later needs Colombia, Panama, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

    Going direct to CODET is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How COFEPRIS sits next to a 20-mile drive (the short version)

    Use the country page for the full pathway. The facts a sponsor searching this clinic needs on one screen:

    COFEPRIS governs clinical investigations in Mexico under the General Health Law. For medical-device trials, sponsors submit a clinical investigation application including protocol, investigator brochure, informed consent, ethics-committee approval, and proof of insurance. Published on clinical-trials-mexico: ethics typically 4-6 weeks; COFEPRIS review typically 4-8 weeks after ethics clearance; combined start-up cited as 2.8 months. bioaccess® manages the process in Spanish. The Ocumetics Mexico results page separately publishes an 8-12 week COFEPRIS band versus a 6-12 month FDA IDE comparison; that is a Mexico-country figure, not a CODET hallway estimate, and it is not an Ocumetics-at-CODET claim.

    We will not invent a Tijuana-only day-count. Ask for a protocol-specific calendar. A surgeon’s email is not a COFEPRIS approval. All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA 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 clinic name

    1. Regulatory-fit, not tourism. Tijuana is convenient. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform; country choice is a review, not a boarding pass.
    2. Protocol, IB, ICF, insurance, and the COFEPRIS packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative 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?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages — not a clinic 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 Tijuana site.

    Do not smear the clinic

    CODET Vision Institute and Dr. Chayet’s research service are serious ophthalmic resources. This page is not a critique of the site. A 20-year LAL history is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

    Colombia is still on the map

    A Tijuana 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® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream CODET / the site bioaccess® / the CRO
    Procedure OR, imaging, refractive and cataract service, PI Protocol fit, training, device accountability
    Ethics Institutional committee calendar Packet, ICF, IB, deficiency responses
    National authority Not the permit holder by sitting 20 miles from SAN COFEPRIS
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One building in Tijuana Colombia (INVIMA), Panama (MINSA/CNBI), Dominican Republic (DIGEMAPS), El Salvador (SRS) still on the platform

    Frequently asked questions

    Can I contract CODET Vision Institute directly?

    You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars, and it can host a visit after a SAN landing. It cannot, by publishing first-in-human-through-commercialization copy, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate CODET as the site if CODET is the right site for your protocol.

    Who is the named investigator on CODET’s research pages?

    Dr. Arturo Chayet, founder, as stated on CODET’s doctor and clinical-research pages. That fact does not make the PI your CRO.

    Does NCT04756908 prove CODET is already running my IOL?

    No. NCT04756908 lists Codet Vision Institute, Tijuana, for the Opira AIOL comparison study sponsored by FSV6, Ltd. It is a public site listing. It is not your protocol, not your COFEPRIS approval, and not a bioaccess® case study.

    What does the CRO still do if the clinic is already identified?

    Regulatory-fit and country choice; the COFEPRIS and ethics 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 Tijuana is not enough. The clinic still does the procedure.

    Is this the same as a commercial LAL or Crystalens case at CODET?

    No. CODET’s Crystalens and RxSight LAL histories mix development-era trials and later commercial experience. A commercial implant is not a first-in-human investigational device study. Do not brief a board as if a medical-tourism LAL schedule were an ISO 14155 investigation.

    Next step

    If the search that brought you here was CODET or Arturo Chayet, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: Laser Center Santo Domingo, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country systems: Mexico, Colombia, Panama. Related: The Panama Clinic, LATAM hospitals vs CRO.