cms.bioaccessla.com

Author: Julio Martinez-Clark

  • INCMNSZ Salvador Zubirán: The NCT Campus String Is Not the COFEPRIS File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics, 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 INCMNSZ Salvador Zubirán as a bioaccess® client.

    If you searched INCMNSZ first-in-human, Salvador Zubiran clinical trial, Instituto Nacional de Ciencias Medicas y Nutricion CRO, or “go direct INCMNSZ Salvador Zubirán,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) in Mexico City is a real national institute. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, 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 this campus 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 merges two NCT spellings of one campus: unaccented Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran and accented Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. It does not clone CODET Vision Institute Tijuana. Tijuana is a different building and a different query.

    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 studies; all years; complete dump), this campus sits here after filters:

    • Unaccented string (Mexico City, Mexico): ALL interventional n=66 (rank 9). Example NCT IDs: NCT00162643, NCT00413699, NCT00517738.
    • Accented string: ALL n=44 (rank 29).

    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 how a sponsor searching the hospital name lands on a campus without landing on an operator.

    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 named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on 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 ethics-committee 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:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation in Tlalpan is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-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 enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

    Ask for a protocol-specific calendar. A hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    INCMNSZ is a serious national institute. Registry volume is not a punchline. Do not merge it into CODET Tijuana.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One 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 COFEPRIS / ethics 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 this campus 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 INCMNSZ Salvador Zubirán directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS 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.

    Is this the same page as CODET Tijuana?

    No. CODET is the Tijuana ophthalmic intercept. This page is INCMNSZ in Mexico City.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. CODET sibling: CODET Vision Tijuana FIH.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Moinhos de Vento: 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 published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, 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 Moinhos de Vento as a bioaccess® client.

    If you searched Hospital Moinhos de Vento first-in-human, Moinhos de Vento Porto Alegre clinical trial, or “go direct Hospital Moinhos de Vento,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Moinhos de Vento in Porto Alegre is a real private 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 this campus 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 the Moinhos campus intercept. It does not clone Hospital de Clínicas de Porto Alegre (CMS 95615) or Fundação Universitaria de Cardiologia (CMS 95612). Three Porto Alegre buildings. Three queries.

    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 studies; all years; complete dump), this campus sits here after filters:

    • Hospital Moinhos de Vento (Porto Alegre, Brazil): ALL interventional n=98 (rank 5); DEVICE n=5 (rank 39). Example NCT IDs: NCT03540589, NCT04176445, NCT04660344.
    • The ALL ranking flagged “CRO often” on collaborator tokens for this string. That is a registry collaborator flag, not a named CRO we will invent, and not proof the hospital is your FIH operator for a new device file.

    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 how a sponsor searching the hospital name lands on a campus without landing on an operator.

    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 named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on 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 ethics-committee 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. A hallway conversation in Moinhos is not that dossier.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-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 enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks; CEPs capped at 30 business days; per-patient $20,000–$35,000 as published there.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Moinhos de Vento is a serious hospital. Registry volume is not a punchline. Do not merge it into HCPA or FUC.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One 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 / ethics 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 this campus 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 Moinhos de Vento directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking 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.

    Is this the same page as HCPA or FUC Porto Alegre?

    No. HCPA is CMS 95615. FUC is CMS 95612. This page is Moinhos only.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Porto Alegre siblings: HCPA, FUC.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Israelita Albert Einstein: 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 published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, 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 Israelita Albert Einstein as a bioaccess® client.

    If you searched Hospital Israelita Albert Einstein first-in-human, Albert Einstein São Paulo clinical trial, Einstein CRO Brazil, or “go direct Hospital Israelita Albert Einstein,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Israelita Albert Einstein in São Paulo is a real private 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 this campus 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 the Einstein campus intercept. It does not clone InCor HCFMUSP (CMS 95522) or Dante Pazzanese. Different buildings. Different NCT strings.

    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 studies; all years; complete dump), this campus sits here after filters:

    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 how a sponsor searching the hospital name lands on a campus without landing on an operator.

    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 named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on 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 ethics-committee 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 Morumbi is not that dossier.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-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 enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANVISA actually works (the short version)

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

    Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Albert Einstein is a serious clinical resource. n=100 on the ALL list is registry volume. It is not a device-CRO quality system. Do not merge Einstein into InCor or Dante.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One 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 / ethics 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 this campus 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 Israelita Albert Einstein directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking 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.

    Is this the same page as InCor or Dante Pazzanese?

    No. Those are separate São Paulo intercepts already live. This page is Einstein only.

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Italiano de Buenos Aires: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, 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 Italiano de Buenos Aires as a bioaccess® client.

    If you searched Hospital Italiano de Buenos Aires first-in-human, Hospital Italiano Buenos Aires clinical trial, HIBA CRO, or “go direct Hospital Italiano de Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Italiano de Buenos Aires is a real private university hospital in Buenos Aires, Argentina. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, 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 this campus 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 the Buenos Aires campus intercept. It does not clone Hospital Italiano Asunción FIH (CMS 95517). Asunción is a different country, a different regulator (DINAVISA), and a different NCT string family (Sanatorio Italiano / Italian Hospital, Asunción). Linking is correct. Collapsing the aliases 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 studies; all years; complete dump), this campus sits here after filters:

    • Hospital Italiano de Buenos Aires (Buenos Aires, Argentina): DEVICE n=10 (rank 11 on the DEVICE list). Example NCT IDs: NCT00932438, NCT02099721, NCT02724540.
    • ALL interventional: n=133 (rank 3 on the ALL list).

    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 how a sponsor searching the hospital name lands on a campus without landing on an operator.

    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 named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on 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 ethics-committee 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:

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in Recoleta is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-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 enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

    Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

    All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not smear the hospital

    Hospital Italiano de Buenos Aires is a serious academic resource. Ranking high on a public ALL-interventional facility list is registry volume, not a punchline. Use the site when the protocol fits. Hire the operator. Keep Asunción on its own page.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One 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 ANMAT / ethics 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 this campus 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 Italiano de Buenos Aires directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT 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.

    Is this the same page as Hospital Italiano Asunción?

    No. Asunción is CMS 95517. This page is Buenos Aires only.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Asunción sibling: Hospital Italiano Asunción FIH.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidade Nove de Julho: 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 merged facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Nove de Julho as a bioaccess® client.

    If you searched Universidade Nove de Julho first-in-human, University of Nove de Julho CRO, Nove de Julho University clinical trials, or “go direct UNINOVE São Paulo,” you followed campus strings ClinicalTrials.gov still publishes as three separate labels. They are one university. They are not a first-in-human medical-device CRO, and they are not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the campus 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 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 merges three accent/language aliases into one slug: Universidade Nove de Julho, University of Nove de Julho, and Nove de Julho University. It does not clone InCor HCFMUSP or Dante Pazzanese. Those are different São Paulo buildings.

    Why the three spellings win the search — and why that is not a CRO

    ClinicalTrials.gov stores Portuguese and English campus names as separate facility keys. On the 1 September 2026 LATAM DEVICE sweep they sit as:

    Public snapshots of those IDs list lead sponsor University of Nove de Julho (or the Portuguese equivalent) and the matching location string. Brief titles cluster around photobiomodulation / phototherapy, low-level laser, kinesio taping, acupuncture on trapezius, neuromuscular stimulus, and tDCS in hemiparesis. 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 university as a client site. Combined DEVICE n=11+9+6 is how a sponsor searching any of the three spellings finds a campus without finding an operator.

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

    A São Paulo private university can provide labs, coordinators, institutional CEP calendars, and investigators who have already appeared on NCT rows under three English/Portuguese spellings. 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.
    • 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). Three NCT spellings do not become 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 UNINOVE-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, Recife, or Porto Alegre, a single-university MSA will not stretch.

    Going direct to Universidade Nove de Julho is how you confirm a room. It is not how you open an investigational file.

    Site versus CRO

    Workstream What Nove de Julho (site) typically owns What the CRO still owns
    Procedure Labs, rooms, 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 São Paulo university (three NCT spellings) 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 university — and do not merge São Paulo buildings

    Universidade Nove de Julho is a serious academic resource. Combined DEVICE volume across three spellings is a signal of how the registry indexes the same campus, not a punchline. This page is not a critique of phototherapy or rehabilitation listings. Volume is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator.

    Do not merge this campus into InCor HCFMUSP, Dante Pazzanese, or the University of Sao Paulo NCT-string page. Different queries. Different buildings.

    What the CRO still does after you have a UNINOVE slide

    1. Regulatory-fit, not tourism. Brazil is a sourced device geography. Three NCT aliases of one private university are 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 Nove de Julho only if it fits the protocol.
    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 Universidade Nove de Julho directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by appearing under three NCT spellings (n=11+9+6 DEVICE), 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.

    Why merge three names onto one page?

    Because they are accent and language aliases of one campus. ClinicalTrials.gov counted them separately. Sponsors search all three. One slug. We do not invent a fourth hospital.

    Did bioaccess® run these NCT IDs?

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

    Next step

    If the search that brought you here was Universidade Nove de Julho, University of Nove de Julho, or Nove de Julho University, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Sibling São Paulo NCT string: University of Sao Paulo.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidade Federal de Pernambuco: 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 string and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidade Federal de Pernambuco as a bioaccess® client.

    If you searched Universidade Federal de Pernambuco first-in-human, UFPE clinical trials, Federal University of Pernambuco CRO, or “go direct UFPE Recife,” you followed a campus string ClinicalTrials.gov still publishes. Universidade Federal de Pernambuco in Recife is a real federal 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 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 Recife 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 is the intercept for the NCT campus string Universidade Federal de Pernambuco. It does not clone São Paulo intercepts already live (InCor, Dante Pazzanese) or the Porto Alegre pages. Recife is a different city.

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

    On the 1 September 2026 ClinicalTrials.gov LATAM DEVICE sweep, Universidade Federal de Pernambuco, Recife, Brazil, is rank 8, n=12, sponsor class OTHER:12 on that ranking row. Example NCT IDs: NCT01449643, NCT01932684, NCT02600052.

    Public snapshots of those three IDs list lead sponsor Universidade Federal de Pernambuco. Brief titles concern inspiratory muscle training and diaphragmatic mobility, incentive spirometry / breath stacking in Parkinson’s disease, and proprioceptive neuromuscular facilitation breathing plus aerobic training. 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 university as a client site. Ranking n=12 is registry volume, not a CRO product.

    That is the leak: a founder searching “UFPE device trial” or “Recife first-in-human” finds a federal campus without finding ANVISA, import, insurance, or 21 CFR 812.28.

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

    A Recife federal university can provide labs, coordinators, institutional CEP calendars, and investigators who have already appeared on 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 university can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing department.
    • 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: IB, protocol, ICF, insurance, GMP evidence). A Recife hallway conversation 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 a Recife-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 Recife enrollment or the indication later needs São Paulo, Porto Alegre, Bogotá, or Panama City, a single-campus MSA will not stretch.

    Going direct to Universidade Federal de Pernambuco is how you confirm a room. It is not how you open an investigational file.

    Site versus CRO

    Workstream What UFPE (site) typically owns What the CRO still owns
    Procedure Labs, rooms, 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 Recife campus 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 university

    Universidade Federal de Pernambuco is a serious academic resource. Ranking eighth on a public DEVICE facility list is a signal of registry volume, not a punchline. This page is not a critique of physiotherapy or respiratory-device listings on ClinicalTrials.gov. Volume is still not a device-CRO quality system. Use the site when the protocol fits. Hire the operator. Do not merge Recife into InCor, Dante Pazzanese, or Hospital de Clínicas de Porto Alegre.

    What the CRO still does after you have a UFPE slide

    1. Regulatory-fit, not tourism. Brazil is a sourced device geography. Recife 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 UFPE only if it fits the protocol.
    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 Universidade Federal de Pernambuco directly for a device FIH?

    You can try. The university can discuss investigator interest, local visit costs, and CEP calendars. It cannot, by ranking n=12 on the DEVICE sweep, 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 NCT01449643, NCT01932684, or NCT02600052?

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

    If I already have Recife, 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 Recife room is not enough.

    Next step

    If the search that brought you here was Universidade Federal de Pernambuco or UFPE, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Panama Eye Center: The NCT Campus String Is Not the MINSA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and the published bioaccess® Panama country page. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the NCT facility string “Panama Eye Center” and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Panama Eye Center as a bioaccess® client.

    If you searched Panama Eye Center first-in-human, Panama Eye Center CRO, Panama Eye Center clinical trials, or “go direct Panama Eye Center,” you followed the exact location string ClinicalTrials.gov still publishes. Panama Eye Center in Panama City is a real ophthalmic facility string in the public file. It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA device file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns MINSA/CNBI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Panama City is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the intercept for the NCT campus string Panama Eye Center (n=13 DEVICE studies on the 1 September 2026 sweep — the highest new Panama device site after The Panama Clinic / CEVAXIN strings already intercepted). It does not clone the live MINIject / STAR-I intercept Panama Eye Centre / Orillac-Calvo MINIject (CMS 95530). That page is a different query: NCT03193736 STAR-I and the British Journal of Ophthalmology site name. Link it. Do not copy it. Do not invent PIs to reconcile spellings.

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

    Device registries write the implant class, the city, and the facility name. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM DEVICE sweep, Panama Eye Center, Panama City, Panama, is rank 7, n=13, all INDUSTRY-sponsored in that ranking row. Example NCT IDs: NCT03374553, NCT03996200, NCT04517786.

    Public snapshots of those three IDs list lead sponsor iSTAR Medical and location facility Panama Eye Center (alongside other countries’ eye hospitals on some records). Brief titles concern MINIject in open-angle glaucoma. That is facility evidence for this NCT string. It is not a reason to republish the STAR-I / Orillac-Calvo page. We will not invent a PI. We will not claim bioaccess® ran these NCTs. No live bioaccess® case-study page names this clinic as a client. iSTAR Medical / MINIject is not claimed as a bioaccess® client here either — the live STAR-I intercept already says the same.

    That is the leak: a founder searching “Panama Eye Center clinical trial” finds n=13 device rows without finding MINSA, CNBI, import, insurance, or 21 CFR 812.28. Ranking after TPC/CEVAXIN is a registry fact, not a CRO product.

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

    A Panama City eye clinic can provide an OR, imaging, and coordinators who have already appeared on industry device NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

    • MINSA and CNBI. The national device file is not a hallway conversation with a coordinator.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a clinic email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. The Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
    • Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-clinic MSA will not stretch.

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

    Site versus CRO

    Workstream What Panama Eye Center (site) typically owns What the CRO still owns
    Procedure OR, imaging, ophthalmic service, local staff Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB, CNBI-registered process
    National authority Not the permit holder by appearing on an NCT MINSA / CNBI
    Import Receiving and storage if contracted Importer of record
    Quality Clinic quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Panama City NCT string Colombia (INVIMA) and the rest of the bioaccess® platform

    How MINSA and CNBI actually work (the short version)

    Use the country pages for the full pathway. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI).

    Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

    • On clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. Currency is the U.S. dollar.
    • On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI often 4–8 weeks; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.

    Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship. That is CRO work, not site work.

    All bioaccess® Panama protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Do not clone the STAR-I page — and do not smear the clinic

    Panama Eye Center is a serious ophthalmic resource on the public NCT file. This page is not a critique of that work. A cluster of industry glaucoma-device rows is a signal of registry volume, not a substitute for a CRO quality system. Use the site when the protocol fits. Hire the operator.

    For STAR-I / Orillac-Calvo / Panama Eye Centre (British spelling) stay on panama-eye-centre-orillac-calvo-miniject. For hospital-named Panama City FIH stay on The Panama Clinic first-in-human. For the vaccine-network brand stay on CEVAXIN FIH. Those are different queries.

    What the CRO still does after you have a Panama Eye Center slide

    1. Regulatory-fit, not tourism. Panama is fast and bilingual. An ophthalmic NCT string is not automatically the right room for every device indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour. Activate Panama Eye Center only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation — eligibility, not a promise of FDA action.

    bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Panama Eye Center directly for a device FIH?

    You can try. A clinic can discuss investigator interest, local visit costs, and institutional ethics calendars. It cannot, by appearing as n=13 DEVICE rows, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Is this the MINIject / Orillac-Calvo page?

    No. That intercept is CMS 95530 for STAR-I (NCT03193736). This page is the NCT campus string “Panama Eye Center” (n=13). Some of those n=13 rows are other iSTAR MINIject listings. Linking is correct. Cloning is not. We do not invent a PI to merge the spellings.

    Did bioaccess® run NCT03374553, NCT03996200, or NCT04517786?

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

    Next step

    If the search that brought you here was Panama Eye Center, start as the operator: contact bioaccess® or book from First-in-Human CRO. STAR-I sibling: Panama Eye Centre / Orillac-Calvo MINIject. Hospital: The Panama Clinic first-in-human. Country: clinical trials in Panama.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • 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®