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Category: Navigating Regulatory Landscapes in Latin America

Explores the regulatory requirements and best practices for conducting clinical trials in Latin America, focusing on medical devices and biopharmaceuticals.

  • Instituto Médico Río Cuarto: 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 Instituto Médico Río Cuarto as a bioaccess® client.

    If you searched Instituto Médico Río Cuarto first-in-human, Instituto Medico Rio Cuarto clinical trial, Río Cuarto CRO Argentina, or “go direct Instituto Médico Río Cuarto,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Médico Río Cuarto in Río Cuarto, Argentina, is a real named institute on ClinicalTrials.gov. 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

    This is the Río Cuarto campus page. Distinct from Sanatorio Allende, Hospital Provincial del Centenario, and Hospital Italiano de La Plata. It is also not Hospital San Roque Córdoba (separate page — a different city and a different NCT string). Sharing Córdoba province is not a license to collapse them.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Instituto Médico Río Cuarto (Río Cuarto, Argentina) — canonical NCT string: ALL interventional n=29; DEVICE n=1. Example NCT IDs: NCT04734873, NCT04847557, NCT04880642.
    • Unaccented alias string Instituto Medico Rio Cuarto: ALL n=13; DEVICE n=3. Listed separately. Same page. We do not invent a combined unique-study total of 29+13. We do not ship a second page for the unaccented spelling.

    These counts are not added together.

    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 institute as a client site.

    That is the leak: a founder searching “Instituto Médico Río Cuarto clinical trial” or the unaccented spelling finds ALL n=29 (DEVICE n=1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Allende, Centenario, Italiano La Plata, or San Roque Córdoba. A named Río Cuarto institute is still a site. An NCT location row is not a CRO.

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

    A named institute 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 institute 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 institute 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 on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Río Cuarto is not an Allende or San Roque Córdoba 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.

    Not a critique of the institute

    Instituto Médico Río Cuarto is a serious named Córdoba-province resource on the public registry. ALL n=29 (DEVICE n=1) is registry volume, not a punchline. It is separate from Allende, Centenario, Italiano La Plata, or Hospital San Roque Córdoba. Use the site when the protocol fits. Hire the operator.

    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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Instituto Médico Río Cuarto directly for a device FIH?

    You can try. The institute 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 institute. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as Sanatorio Allende, Centenario Rosario, Italiano La Plata, or Hospital San Roque Córdoba?

    No. Allende has its own page (Córdoba city). Centenario has its own page (Rosario). Italiano La Plata has its own page. Hospital San Roque Córdoba has its own page. This page is Instituto Médico Río Cuarto only. The unaccented NCT spelling stays on this page; we do not combine them n.

    Should I add ALL n=29 and the unaccented ALL n=13?

    No. Alias n is listed separately. A combined unique-study total is not published. The unaccented string is the same campus on the same page.

    Does DEVICE n=1 mean this institute already owns ANMAT for a new device FIH?

    No. DEVICE n is unique NCT IDs on the device filter for this facility string. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate. An NCT location row is not that file.

    Is Río Cuarto the same as Hospital San Roque in Córdoba city?

    No. San Roque Córdoba is a different hospital in a different city. This page is the named Río Cuarto institute.

    Did bioaccess® run NCT04734873?

    No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

    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. Country: clinical trials in Argentina. Córdoba-city sibling (do not merge): Sanatorio Allende.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Club de Leones Cruz del Sur: The NCT Campus String Is Not the ISP 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 ISP, 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 Club de Leones Cruz del Sur as a bioaccess® client.

    If you searched Club de Leones Cruz del Sur first-in-human, Corporación de Rehabilitación Club de Leones Punta Arenas clinical trial, Cruz del Sur Magallanes CRO, or “go direct Club de Leones Cruz del Sur,” you followed a campus string ClinicalTrials.gov still publishes. Corporación de Rehabilitación Club de Leones Cruz del Sur in Punta Arenas, Chile, is a real Magallanes rehab-hospital string on ClinicalTrials.gov. It is a unique Magallanes rehab hospital. It is not a Santiago university hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, Ethical-Scientific Committee (Law 20.120), 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 is the Punta Arenas / Magallanes rehab-hospital page. Distinct from Hospital Clínico Universidad de Chile, Hospital Clínico Universidad Católica, and Universidad Andrés Bello. Punta Arenas is not Santiago. A rehab hospital in Magallanes is not Católica, not UChile, and not UNAB. Linking is correct. Collapsing every Chilean campus into Santiago 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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Corporación de Rehabilitación Club de Leones Cruz del Sur (Punta Arenas, Chile) — canonical NCT string: ALL interventional n=9; DEVICE n=8. Example NCT IDs: NCT04228224, NCT04245059, NCT04249349.

    We will not invent a global CSV rank. We will not invent PAHO/WHO Level 4 standing for ISP. We will not merge this Magallanes campus into Santiago university hospitals.

    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.

    That is the leak: a founder searching “Club de Leones Cruz del Sur clinical trial” or “Punta Arenas rehab FIH” finds ALL n=9 (DEVICE n=8) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on UChile, Católica, or UNAB. Magallanes is still not Santiago. A rehab hospital is still not a CRO. DEVICE n=8 on a small ALL n is registry volume, not a claim that the campus owns ISP for a new device file.

    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:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation in Punta Arenas is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
    • 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 ISP actually works (the short version)

    Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

    Ask for a protocol-specific calendar. A hospital email is not ISP 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.

    Not a critique of the hospital

    Club de Leones Cruz del Sur is a serious Magallanes rehab hospital. ALL n=9 (DEVICE n=8) is registry volume, not a punchline. It is separate from UChile, Católica, or UNAB. We do not invent PAHO/WHO Level 4 for ISP. Use the site when the protocol fits. Hire the operator.

    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 ISP / 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Club de Leones Cruz del Sur 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 ISP 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 answers the search; it does not claim the studies.

    Is this the same page as Hospital Clínico Universidad de Chile, Hospital Clínico Universidad Católica, or Universidad Andrés Bello?

    No. UChile has its own page (Santiago). Católica has its own page (Santiago). UNAB has its own page (Santiago). This page is Corporación de Rehabilitación Club de Leones Cruz del Sur, Punta Arenas, Magallanes only.

    Is Punta Arenas under a different national agency than Santiago?

    No. ISP is still the national file. Typical ISP review ~30 business days on Chile blogs. Commercial ISP registration 30–90 days is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit.

    Does DEVICE n=8 on ALL n=9 mean this campus already owns ISP for a new device FIH?

    No. DEVICE n is unique NCT IDs on the device filter for this facility string. It is not ISP authorization, not import, and not a 21 CFR 812.28 package.

    Does ISP have PAHO/WHO Level 4 standing?

    We will not invent that claim on this page. Use the live Chile country page for what is actually published. Typical ISP review ~30 business days; commercial ISP registration 30–90 days is a different file.

    Is this a Santiago university hospital?

    No. This is a unique Magallanes rehab hospital in Punta Arenas. UChile, Católica, and UNAB remain on their own pages.

    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. Country: clinical trials in Chile.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • UFCSPA: 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 UFCSPA as a bioaccess® client.

    If you searched UFCSPA first-in-human, Federal University of Health Sciences of Porto Alegre clinical trial, Universidade Federal de Ciências da Saúde de Porto Alegre CRO, or “go direct UFCSPA,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Health Sciences of Porto Alegre (UFCSPA) in Porto Alegre, Brazil, is a real university string on ClinicalTrials.gov. It is not HCPA. It is not UFRGS-as-HCPA. 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.

    This is the UFCSPA university page. Distinct from Hospital de Clínicas de Porto Alegre. We do not merge UFRGS-as-HCPA. Distinct from Santa Casa Porto Alegre, Moinhos de Vento, Hospital Mãe de Deus (separate page), São Lucas PUCRS, and Fundação Universitaria de Cardiologia. Sharing Porto Alegre is not a license to collapse them.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Federal University of Health Sciences of Porto Alegre (Porto Alegre, Brazil) — canonical English NCT string: ALL interventional n=21; DEVICE n=5. Example NCT IDs: NCT02088138, NCT02817867, NCT02818608.
    • Portuguese alias Universidade Federal de Ciências da Saúde de Porto Alegre: ALL n=17.
    • Short alias UFCSPA: ALL n=6.

    List each n separately. We do not add 21+17+6 as a combined unique-study total. We do not merge HCPA or UFRGS-as-HCPA onto this page.

    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 university as a client site.

    That is the leak: a founder searching “UFCSPA clinical trial” or “Federal University of Health Sciences of Porto Alegre FIH” finds ALL n=21 (DEVICE n=5; Portuguese ALL n=17; short ALL n=6) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, UFRGS-as-HCPA, Santa Casa, Moinhos, Mãe de Deus, PUCRS, or FUC. A health-sciences university string is still not a CRO. We will not treat HCPA as this campus.

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

    A named university 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 university 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 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 hallway conversation at this campus is not that dossier. A hallway conversation at UFCSPA is not an HCPA file and is not UFRGS-as-HCPA.
    • 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 in 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.

    Not a critique of the university

    UFCSPA is a serious public health-sciences university. ALL n=21 (DEVICE n=5) on the English string, Portuguese ALL n=17, and short ALL n=6 are registry volume, not a punchline. The alias counts are not added together. This page is separate from HCPA, UFRGS-as-HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, PUCRS, or FUC. Use the site when the protocol fits. Hire the operator.

    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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract UFCSPA directly for a device FIH?

    You can try. The university 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 university. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as HCPA, UFRGS-as-HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, PUCRS, or FUC?

    No. HCPA has its own page. UFRGS-as-HCPA is not this campus and is not merged here. Santa Casa Porto Alegre has its own page. Moinhos has its own page. Mãe de Deus has its own page. São Lucas PUCRS has its own page. FUC has its own page. This page is Federal University of Health Sciences of Porto Alegre / UFCSPA only.

    Why three ALL n values on one page?

    ClinicalTrials.gov stored an English canonical string (ALL n=21; DEVICE n=5), a Portuguese alias (ALL n=17), and a short UFCSPA alias (ALL n=6). This page covers them as one university campus family. It does not add the counts.

    Is n=21 plus n=17 plus n=6 equal to 44 unique studies?

    We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a combined total.

    Is this HCPA or UFRGS?

    No. HCPA has its own page. UFRGS-as-HCPA is a different string family and is not merged onto this page. UFCSPA is the Federal University of Health Sciences of Porto Alegre.

    Does DEVICE n=5 mean this university already owns ANVISA for a new device FIH?

    No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 5 is a registry token, not a dossier.

    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. Country: clinical trials in Brazil. Porto Alegre sibling (do not merge): HCPA.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Sírio-Libanês: 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 Sírio-Libanês as a bioaccess® client.

    If you searched Hospital Sirio-Libanes first-in-human, Hospital Sírio-Libanês São Paulo clinical trial, Sirio Libanes CRO, or “go direct Hospital Sírio-Libanês,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Sírio-Libanês in São Paulo, Brazil, is a real private hospital string on ClinicalTrials.gov. This page is the São Paulo campus family. It is not Brasília and not Buenos Aires. 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 is the São Paulo Sírio-Libanês page. São Paulo spelling variants merge onto this page as NCT spellings of the same campus family — not as different hospitals we invent. We do not merge Brasília or Buenos Aires Sírio strings. Distinct from Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and ICESP. Sharing São Paulo is not a license to collapse them.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Hospital Sírio-Libanês (São Paulo, Brazil) — canonical NCT string: ALL interventional n=29; DEVICE n=1. Example NCT IDs: NCT01667419, NCT01686412, NCT02118584.
    • Hospital Sírio Libanês (same SP campus family): ALL n=18.
    • Hospital Sirio Libanes (same SP campus family): ALL n=17.
    • Hospital Sirio-Libanes (same SP campus family): ALL n=8.
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes (same SP campus family): ALL n=22. Named as an NCT spelling of this São Paulo campus family. We do not invent that it is a different hospital.

    List each n separately. We do not add 29+18+17+8+22 as a combined unique-study total. We do not merge Brasília or Buenos Aires Sírio strings onto this page.

    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.

    That is the leak: a founder searching “Hospital Sírio-Libanês clinical trial” or “Sirio Libanes São Paulo FIH” finds ALL n=29 (DEVICE n=1) and a stack of spelling aliases without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Einstein, HCor, ICESP, Brasília Sírio, or Buenos Aires Sírio. A private São Paulo hospital is still not a CRO. Spelling variants are not extra hospitals we invent.

    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 at this campus is not that dossier. A hallway conversation at Sírio-Libanês in São Paulo is not an Einstein, HCor, or ICESP file, and it is not a Brasília or Buenos Aires Sírio 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 ANVISA actually works (the short version)

    Use Clinical Trials in 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.

    Not a critique of the hospital

    Hospital Sírio-Libanês in São Paulo is a serious private hospital. ALL n=29 (DEVICE n=1) on the canonical string, and the listed spelling-variant n values, are registry volume, not a punchline. The alias counts are not added together. This page is separate from Brasília or Buenos Aires Sírio strings. This page is separate from Einstein, HCor, or ICESP. Use the São Paulo site when the protocol fits. Hire the operator.

    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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Sírio-Libanês 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 answers the search; it does not claim the studies.

    Is this the same page as Einstein, HCor, ICESP, or a Brasília / Buenos Aires Sírio campus?

    No. Einstein has its own page. HCor has its own page. ICESP has its own page. Brasília and Buenos Aires Sírio strings are other cities and are not merged here. This page is the São Paulo Hospital Sírio-Libanês campus family only. The Sociedade Beneficente spelling is an NCT string for this family, not a second hospital we invent.

    Why so many ALL n values on one page?

    ClinicalTrials.gov stored several São Paulo spellings of one campus family. We list each n. We do not publish a combined total. We do not invent that they are different hospitals.

    Is n=29 plus n=18 plus n=17 plus n=8 plus n=22 a unique-study total?

    We will not claim that. Overlap between spelling rows is expected. We list each n. We do not publish a combined total.

    Is this the Brasília or Buenos Aires Sírio campus?

    No. Those strings are other cities. This page is São Paulo only.

    Does DEVICE n=1 mean this hospital already owns ANVISA for a new device FIH?

    No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 1 is a registry token, not a dossier.

    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. Country: clinical trials in Brazil. São Paulo sibling (do not merge): Einstein.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidade Federal de Minas Gerais: 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 Universidade Federal de Minas Gerais as a bioaccess® client.

    If you searched Federal University of Minas Gerais first-in-human, UFMG Belo Horizonte clinical trial, Universidade Federal de Minas Gerais CRO, or “go direct Universidade Federal de Minas Gerais,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Minas Gerais (Universidade Federal de Minas Gerais) in Belo Horizonte, Brazil, is a real university string on ClinicalTrials.gov. It is not Hospital das Clínicas da UFMG as this page’s campus. 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the university NCT string. Distinct from Hospital das Clínicas da UFMG — a different NCT string family, the same way University of São Paulo is not HCFMUSP. Distinct from Santa Casa de Belo Horizonte. Sharing Belo Horizonte is not a license to collapse the university into the teaching hospital or into Santa Casa. Related HC-UFMG strings may be named only to distinguish them. They are not this campus.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Federal University of Minas Gerais (Belo Horizonte, Brazil) — canonical English NCT string: ALL interventional n=29; DEVICE n=3. Example NCT IDs: NCT00106964, NCT01006473, NCT01006486.
    • Portuguese alias Universidade Federal de Minas Gerais (same city): ALL n=17. That alias is named here so a founder searching the Portuguese spelling still lands on this page. We do not publish a second page. We do not add 29+17 as a combined unique-study total.

    Alias counts are listed separately. We will not merge Hospital das Clínicas da UFMG as this page’s campus. We will not invent a combined count with Santa Casa BH.

    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 university as a client site.

    That is the leak: a founder searching “UFMG clinical trial” or “Federal University of Minas Gerais FIH” finds ALL n=29 (DEVICE n=3; Portuguese alias ALL n=17) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital das Clínicas da UFMG or Santa Casa BH. A university NCT string is still not a CRO. We will not treat the teaching-hospital string as this campus.

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

    A named university 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 university 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 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 hallway conversation at this campus is not that dossier. A hallway conversation on the university string is not a Santa Casa BH file and is not Hospital das Clínicas da UFMG as this campus.
    • 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 in 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.

    Not a critique of the university

    Universidade Federal de Minas Gerais is a serious public university. ALL n=29 (DEVICE n=3) on the English string, and ALL n=17 on the Portuguese alias, is registry volume, not a punchline. The 29+17 counts are not added together. Hospital das Clínicas da UFMG is not this page’s campus. This page is separate from Santa Casa BH. Use the site when the protocol fits. Hire the operator.

    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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Universidade Federal de Minas Gerais directly for a device FIH?

    You can try. The university 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 university. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as Hospital das Clínicas da UFMG or Santa Casa de Belo Horizonte?

    No. Hospital das Clínicas da UFMG is a different NCT string family — like USP versus HCFMUSP — and is not this page’s campus. Santa Casa de Belo Horizonte has its own page. This page is the Federal University of Minas Gerais / Universidade Federal de Minas Gerais university string only.

    Why two ALL n values on one page?

    ClinicalTrials.gov stored an English canonical string (ALL n=29; DEVICE n=3) and a Portuguese alias (ALL n=17). This page covers both as one university campus family. It does not add the counts.

    Is n=29 plus n=17 equal to 46 unique studies?

    We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a combined total.

    Is this Hospital das Clínicas da UFMG?

    No. That is a different NCT string, the same distinction as University of São Paulo versus HCFMUSP. Related strings may appear only to keep the campuses apart. This page is the university string.

    Does DEVICE n=3 mean this university already owns ANVISA for a new device FIH?

    No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 3 is a registry token, not a dossier.

    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. Country: clinical trials in Brazil. Belo Horizonte sibling (do not merge): Santa Casa de Belo Horizonte.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Mãe de Deus: 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 Mãe de Deus as a bioaccess® client.

    If you searched Hospital Mae de Deus first-in-human, Hospital Mãe de Deus Porto Alegre clinical trial, Mae de Deus CRO, or “go direct Hospital Mãe de Deus,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Mae de Deus (accented Hospital Mãe de Deus) in Porto Alegre, Brazil, is a real hospital string on ClinicalTrials.gov. This page is that campus family only. 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 is the Porto Alegre Mãe de Deus page. Distinct from Hospital de Clínicas de Porto Alegre, Hospital Moinhos de Vento, Irmandade da Santa Casa de Misericórdia de Porto Alegre, UFCSPA (separate page), and Hospital Bruno Born in Lajeado (separate page). We do not merge HGB, Giovanni Battista, or Centro Gaucho as this page’s campus — those are different NCT strings. We do not merge UFRGS-as-HCPA.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Hospital Mae de Deus (Porto Alegre, Brazil) — canonical unaccented NCT string: ALL interventional n=31. DEVICE n=0 on the ranking table. Example NCT IDs: NCT00071331, NCT00430352, NCT00910286.
    • Accented alias Hospital Mãe de Deus (same city): ALL n=20. That alias is named here so a founder searching the ã spelling still lands on this page. We do not publish a second page. We do not add 31+20 as a combined unique-study total.

    Alias counts are listed separately. We will not invent a DEVICE n beyond the DEVICE 0 on the canonical string. We will not merge HGB / Giovanni Battista / Centro Gaucho onto this campus.

    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.

    That is the leak: a founder searching “Hospital Mãe de Deus clinical trial” or “Mae de Deus Porto Alegre FIH” finds ALL n=31 (accented alias ALL n=20) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, Moinhos, Santa Casa Porto Alegre, UFCSPA, or Bruno Born. A private Porto Alegre hospital is still not a CRO. We will not paste HGB or Centro Gaucho onto this page.

    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 at this campus is not that dossier. A hallway conversation at Mãe de Deus is not an HCPA, Moinhos, or Lajeado 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 ANVISA actually works (the short version)

    Use Clinical Trials in 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.

    Not a critique of the hospital

    Hospital Mãe de Deus is a serious Porto Alegre hospital. ALL n=31 on the unaccented string (accented ALL n=20) is registry volume, not a punchline. The accented row is a spelling alias, not a second hospital and not a combined total we invent. It is separate from HCPA, Moinhos, Santa Casa Porto Alegre, UFCSPA, or Bruno Born. HGB / Giovanni Battista / Centro Gaucho is not this campus. Use the site when the protocol fits. Hire the operator.

    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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Mãe de Deus 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 answers the search; it does not claim the studies.

    Is this the same page as HCPA, Moinhos, Santa Casa Porto Alegre, UFCSPA, Bruno Born, or HGB / Centro Gaucho?

    No. HCPA has its own page. Moinhos has its own page. Santa Casa Porto Alegre has its own page. UFCSPA has its own page. Bruno Born is Lajeado (separate page). HGB / Giovanni Battista / Centro Gaucho are different NCT strings and are not this page’s campus. This page is Hospital Mae de Deus / Hospital Mãe de Deus, Porto Alegre only.

    Why two ALL n values on one page?

    ClinicalTrials.gov stored an unaccented canonical string (ALL n=31) and an accented alias (ALL n=20). This page covers both as one campus. It does not add the counts.

    Is n=31 plus n=20 equal to 51 unique studies?

    We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a combined total.

    Why not invent a DEVICE n?

    DEVICE n=0 on the ranking table for the canonical string. We will not invent a DEVICE ranking.

    Is this Hospital Giovanni Battista or Centro Gaucho?

    No. Those are different NCT strings. We do not merge them as this page’s campus.

    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. Country: clinical trials in Brazil. Porto Alegre sibling (do not merge): Moinhos de Vento.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Bruno Born: 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 Bruno Born as a bioaccess® client.

    If you searched Hospital Bruno Born first-in-human, Bruno Born Lajeado clinical trial, Hospital Bruno Born CRO, or “go direct Hospital Bruno Born,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Bruno Born in Lajeado, Rio Grande do Sul, Brazil, is a real hospital string on ClinicalTrials.gov. Lajeado is not Porto Alegre. 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 is the Lajeado campus page. Distinct from Hospital de Clínicas de Porto Alegre, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Hospital Moinhos de Vento, Hospital Mãe de Deus (separate page), UFCSPA (separate page), Hospital Ernesto Dornelles, Hospital Nossa Senhora da Conceição, and Hospital São Lucas da PUCRS. Lajeado is a different city. Sharing Rio Grande do Sul is not a license to collapse every hospital into Porto Alegre.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    We will not invent a DEVICE ranking from the top-40 CSV. We will not borrow a Porto Alegre count onto Lajeado.

    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.

    That is the leak: a founder searching “Hospital Bruno Born clinical trial” or “Lajeado FIH” finds ALL n=31 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS. Lajeado is still not Porto Alegre. An NCT city field is not a license to collapse every Rio Grande do Sul hospital.

    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 at this campus is not that dossier. A hallway conversation in Lajeado is not a Porto Alegre 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 ANVISA actually works (the short version)

    Use Clinical Trials in 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.

    Not a critique of the hospital

    Hospital Bruno Born is a serious Lajeado resource. ALL n=31 is registry volume, not a punchline. It is separate from HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS. Do not treat every Rio Grande do Sul string as one CEP. Use the site when the protocol fits. Hire the operator.

    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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Bruno Born 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 answers the search; it does not claim the studies.

    Is this the same page as HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, UFCSPA, Dornelles, Conceição, or PUCRS?

    No. HCPA has its own page. Santa Casa Porto Alegre has its own page. Moinhos has its own page. Mãe de Deus has its own page (Porto Alegre). UFCSPA has its own page. Dornelles has its own page. Conceição has its own page. São Lucas PUCRS has its own page. This page is Hospital Bruno Born, Lajeado only.

    Is Lajeado the same metro as Porto Alegre?

    No. Lajeado is a different city in Rio Grande do Sul. Sharing a state is not a license to collapse the hospital into HCPA, Santa Casa, Moinhos, or Mãe de Deus.

    Does ALL n=31 mean this campus already owns ANVISA?

    No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count for this string. We will not invent a DEVICE n.

    Is this the same page as Hospital Mãe de Deus?

    No. Mãe de Deus is Porto Alegre (separate page). Bruno Born is Lajeado. Different city. Different NCT string.

    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. Country: clinical trials in Brazil. Porto Alegre sibling (do not merge): HCPA.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CORI La Rioja: 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 CORI La Rioja as a bioaccess® client.

    If you searched CORI La Rioja first-in-human, Centro Oncologico Riojano Integral clinical trial, CORI Argentina CRO, or “go direct CORI La Rioja,” you followed a campus string ClinicalTrials.gov still publishes. Centro Oncológico Riojano Integral (CORI) in La Rioja city, Argentina, is a real named oncology-center string on ClinicalTrials.gov. This page is La Rioja. It is not Buenos Aires. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

    This is the La Rioja oncology-center page. Distinct from ICESP, Barretos Cancer Hospital, INEN Lima, INCan Mexico, and Liga Norte Riograndense Contra o Câncer. La Rioja is not São Paulo, not Barretos, not Lima, not Mexico City, not Natal, and not Buenos Aires. An oncology NCT string is not a license to collapse every cancer campus in Latin America.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • Centro Oncologico Riojano Integral (CORI) (La Rioja, Argentina): ALL interventional n=31; DEVICE n=0 on the ranking table. Example NCT IDs: NCT00849667, NCT01572038, NCT01663727.

    We will not invent a DEVICE ranking from the top-40 CSV. We will not move this campus to Buenos Aires.

    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 center as a client site.

    That is the leak: a founder searching “CORI La Rioja clinical trial” or “Centro Oncológico Riojano Integral FIH” finds ALL n=31 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, INEN, INCan, or Liga Norte. La Rioja city is still not Buenos Aires, and an oncology center is still not a CRO.

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

    A named center 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 center 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 center 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 on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in La Rioja is not an ICESP, Barretos, or Buenos Aires 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.

    Not a critique of the center

    CORI is a serious named La Rioja oncology resource. ALL n=31 is registry volume, not a punchline. It is separate from ICESP, Barretos, INEN, INCan, or Liga Norte. Do not move it to Buenos Aires. Use the site when the protocol fits. Hire the operator.

    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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract CORI La Rioja directly for a device FIH?

    You can try. The center 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as ICESP, Barretos, INEN, INCan, or Liga Norte?

    No. ICESP has its own page (São Paulo, ANVISA). Barretos has its own page (Brazil). INEN has its own page (Lima, Peru — INS, not ANMAT). INCan has its own page (Mexico City, COFEPRIS). Liga Norte has its own page (Natal). This page is Centro Oncológico Riojano Integral (CORI), La Rioja city only.

    Is La Rioja under a different national agency than Buenos Aires?

    No. ANMAT is still the national file. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate. The city is still La Rioja, not Buenos Aires.

    Does ALL n=31 mean this center is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count. We will not invent a DEVICE n.

    Is this the same campus as ICESP because both treat cancer?

    No. ICESP is São Paulo. CORI is La Rioja. Sharing an oncology service line is not a license to collapse them.

    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. Country: clinical trials in Argentina.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CPQuali: 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 CPQuali as a bioaccess® client.

    If you searched CPQuali Pesquisa Clinica first-in-human, CPQuali São Paulo clinical trial, CPQuali CRO Brazil, or “go direct CPQuali,” you followed a campus string ClinicalTrials.gov still publishes. CPQuali Pesquisa Clínica in São Paulo, Brazil, is a real named research-clinic string on ClinicalTrials.gov. The named São Paulo research clinic is the site. It is not the CRO. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named São Paulo research clinic. Distinct from CEPIC, Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing “pesquisa clínica” in the name is not a license to collapse them.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    We will not invent a DEVICE ranking from the top-40 CSV. We will not treat the words “Pesquisa Clínica” as proof this campus is your FIH operator.

    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 clinic as a client site.

    That is the leak: a founder searching “CPQuali São Paulo clinical trial” or “CPQuali Pesquisa Clínica FIH” finds ALL n=31 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, Einstein, HCor, or Santa Marcelina. A named research clinic is still a site. An NCT location row is not a CRO.

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

    A named clinic 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 clinic 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 clinic 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 at this campus is not that dossier. A hallway conversation at CPQuali is not a CEPIC, Einstein, HCor, or Santa Marcelina 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 ANVISA actually works (the short version)

    Use Clinical Trials in 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.

    Not a critique of the clinic

    CPQuali is a serious named São Paulo research clinic on the public registry. ALL n=31 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. It is separate from CEPIC, Einstein, HCor, or Santa Marcelina. Use the site when the protocol fits. Hire the operator.

    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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract CPQuali directly for a device FIH?

    You can try. The clinic 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 clinic. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as CEPIC, Einstein, HCor, or Santa Marcelina?

    No. CEPIC has its own page — a different named São Paulo investigative clinic. Einstein has its own page. HCor has its own page. Santa Marcelina has its own page. This page is CPQuali Pesquisa Clínica only. The named clinic is the site, not the CRO.

    Is CPQuali the same as CEPIC?

    No. CEPIC is Centro Paulista de Investigação Clínica. CPQuali is a different NCT facility string. Sharing São Paulo and sharing “clínica” in the name is not a merge.

    Does “Pesquisa Clínica” in the name mean this clinic owns ANVISA?

    No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A clinic name is not a dossier.

    Did bioaccess® run NCT03987919 because it also appears on CEPIC?

    No. An NCT ID can list more than one facility. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count. We will not invent a DEVICE ranking.

    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. Country: clinical trials in Brazil. São Paulo sibling (do not merge): CEPIC.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • FAICIC Veracruz: 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 FAICIC Veracruz as a bioaccess® client.

    If you searched FAICIC Veracruz first-in-human, FAICIC Clinical Research Veracruz clinical trial, FAICIC S. de R.L. de C.V. CRO, or “go direct FAICIC Veracruz,” you followed a campus string ClinicalTrials.gov still publishes. FAICIC S. de R.L. de C.V. in Veracruz, Mexico, is a real named research-clinic string on ClinicalTrials.gov. FAICIC Clinical Research is a spelling of the same campus on this page. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the Veracruz named research clinic. Distinct from INCMNSZ Salvador Zubirán, INCan, Centro de Investigación Clínica de Oaxaca, Hospital Civil de Guadalajara Fray Antonio Alcalde, UNAM Optometry Clinic, and Hospital Universitario Dr. José Eleuterio González. Veracruz is not Mexico City, not Oaxaca, not Guadalajara, and not Monterrey.

    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), this campus sits here after filters:

    Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

    • FAICIC S. de R.L. de C.V. (Veracruz, Mexico) — canonical NCT string: ALL interventional n=31; DEVICE n=1. Example NCT IDs: NCT03950232, NCT04173273, NCT04642638.
    • Spelling on this page only, no extra n: FAICIC Clinical Research. We list the alias so a founder searching that wording still lands here. We do not invent a second count. We do not publish a combined unique-study total.

    We will not invent extra n for the Clinical Research spelling.

    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 clinic as a client site.

    That is the leak: a founder searching “FAICIC Veracruz clinical trial” or “FAICIC Clinical Research FIH” finds ALL n=31 (DEVICE n=1) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Oaxaca, Guadalajara, UNAM optometry, or Eleuterio González. A named Veracruz clinic is still not a CRO.

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

    A named clinic 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 clinic 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 clinic is not built to own for an investigational device:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation in Veracruz 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 in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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.

    Not a critique of the clinic

    FAICIC is a serious named Veracruz research clinic on the public registry. ALL n=31 (DEVICE n=1) is registry volume, not a punchline. It is separate from INCMNSZ, INCan, Oaxaca, Guadalajara, UNAM optometry, or Eleuterio González. Use the site when the protocol fits. Hire the operator.

    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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract FAICIC Veracruz directly for a device FIH?

    You can try. The clinic 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 clinic. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as INCMNSZ, INCan, Oaxaca, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González?

    No. INCMNSZ has its own page (Mexico City). INCan has its own page (Mexico City). Oaxaca has its own page. Hospital Civil Guadalajara has its own page. UNAM optometry has its own page. Eleuterio González has its own page (Monterrey). This page is FAICIC S. de R.L. de C.V., Veracruz only. FAICIC Clinical Research is a spelling of this campus, not a second city.

    Is FAICIC Clinical Research a different campus?

    No. It is a spelling of FAICIC S. de R.L. de C.V. on this page. We do not invent a second n. We do not publish a combined total.

    Is Veracruz under a different national agency than Mexico City?

    No. COFEPRIS is still the national file. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Registro sanitario (~30 working days) is a different file.

    Does DEVICE n=1 mean this clinic already owns COFEPRIS for a new device FIH?

    No. A DEVICE n of 1 is a registry token. An NCT location row is not a COFEPRIS authorization. Keep trial clocks separate from registro.

    Did bioaccess® run NCT04173273?

    No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

    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.

    Julio G. Martinez-Clark, CEO · bioaccess®