cms.bioaccessla.com

Category: Advantages of Conducting Trials in Latin America

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

  • Hospital Felício Rocho: 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 Felício Rocho as a bioaccess® client.

    If you searched Hospital Felicio Rocho first-in-human, Hospital Felício Rocho Belo Horizonte clinical trial, Felício Rocho CRO, or “go direct Hospital Felício Rocho,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Felicio Rocho in Belo Horizonte, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the named Belo Horizonte hospital. Distinct from Santa Casa de Belo Horizonte (CMS 95660) and from Universidade Federal de Minas Gerais (CMS 95675). Sharing Belo Horizonte 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Felicio Rocho (Belo Horizonte, Brazil) — leftover ranking / canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00094302, NCT00413218, NCT00634049. JSONL confirm (1 September 2026 dump): unique NCT IDs n=25 on this Belo Horizonte string.
    • Accented alias Hospital Felício Rocho: ALL n=17. Listed separately. Same slug. We do not invent a unique-study union of 25+17. We do not ship a second slug for the accented spelling.

    Cite leftover ALL n=25 and DEVICE n=0 on the canonical string. Cite accented ALL n=17 separately. Do not add them.

    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 Felício Rocho clinical trial” or the unaccented spelling finds leftover ALL n=25 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Santa Casa BH or UFMG. A named Belo Horizonte hospital is still a site. An NCT location row is not a CRO.

    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 Felício Rocho is not a Santa Casa BH file and is not a UFMG university-string 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the hospital

    Hospital Felicio Rocho is a serious named Belo Horizonte hospital on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Santa Casa BH or UFMG. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Felício Rocho directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Santa Casa de Belo Horizonte or Universidade Federal de Minas Gerais?

    No. Santa Casa BH is CMS 95660. UFMG is CMS 95675. This page is Hospital Felicio Rocho, Belo Horizonte only. Accented ALL n=17 stays listed separately; we do not union.

    Should I add leftover ALL n=25 and the accented ALL n=17?

    No. Alias n is listed separately. A unique-study union is not published. The accented spelling is the same Belo Horizonte campus on the same slug.

    Is this Santa Casa BH or UFMG?

    No. Santa Casa de Belo Horizonte is CMS 95660. UFMG is CMS 95675 (university string). This page is Hospital Felicio Rocho only.

    Why DEVICE n=0?

    That is the leftover-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=25 is still not ANVISA authorization.

    Did bioaccess® run NCT00094302?

    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 Brazil. Belo Horizonte sibling (do not merge): Santa Casa de Belo Horizonte.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CEMEC São Bernardo: 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 CEMEC São Bernardo as a bioaccess® client.

    If you searched CEMEC São Bernardo first-in-human, Centro Multidisciplinar de Estudos Clínicos clinical trial, CEMEC São Bernardo do Campo CRO, or “go direct CEMEC São Bernardo,” you followed a campus string ClinicalTrials.gov still publishes. CEMEC – Centro Multidisciplinar de Estudos Clínicos in São Bernardo do Campo, Brazil, is a real named research-center string on ClinicalTrials.gov. São Bernardo do Campo is not São Paulo capital. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the São Bernardo do Campo named research center. Distinct from CEPIC (CMS 95662), CPCLIN, and CPQuali (CMS 95671). Sharing a “C” research-clinic prefix or sharing Greater São Paulo is not a license to collapse them. This is not a São Paulo capital 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • CEMEC – Centro Multidisciplinar de Estudos Clínicos (São Bernardo do Campo, Brazil) — leftover ranking row: ALL interventional n=26; DEVICE n=0. Example NCT IDs: NCT03057951, NCT03057977, NCT03071692.
    • JSONL confirm on the named campus string (1 September 2026 dump): unique NCT IDs n=28. Cite leftover ALL n=26 as the ranking table. Cite JSONL n=28 as the named string. Same campus. Not two centers. Do not union with other CEMEC spellings.
    • Alias Centro Multidisciplinar de Estudos Clinicos: ALL n=10. Listed separately. Same slug. We do not invent a unique-study union of 26+28+10. We do not ship a second slug for the unaccented expanded spelling.

    Cite leftover ALL n=26 as ranking. Cite canonical JSONL n=28 as the named string. Cite alias ALL n=10 separately. Do not add them. DEVICE n=0; we will not pad it.

    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 “CEMEC São Bernardo clinical trial” or “Centro Multidisciplinar de Estudos Clínicos FIH” finds leftover ALL n=26 (JSONL named-string n=28) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPCLIN, or CPQuali. São Bernardo do Campo is still not São Paulo capital. A named research center is still a site. An NCT location row is 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:

    • 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 São Bernardo do Campo is not a CEPIC, CPCLIN, or CPQuali 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the center

    CEMEC in São Bernardo do Campo is a serious named research center on the public registry. Leftover ALL n=26 is registry volume, not a punchline. JSONL n=28 is the same named string, not a second campus. Do not invent a DEVICE n. Do not merge it into CEPIC, CPCLIN, or CPQuali. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract CEMEC São Bernardo 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 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 center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as CEPIC, CPCLIN, or CPQuali?

    No. CEPIC is CMS 95662 (São Paulo). CPCLIN is a São Paulo research-clinic intercept. CPQuali is CMS 95671 (São Paulo). This page is CEMEC in São Bernardo do Campo only. Alias ALL n=10 stays listed separately; leftover ALL n=26 is ranking; JSONL n=28 is the named string. We do not union.

    Should I add leftover ALL n=26, JSONL n=28, and alias ALL n=10?

    No. Leftover ALL n=26 is the ranking row. JSONL n=28 is the same named hospital string confirmed. Alias n=10 is listed separately. A unique-study union is not published.

    Is CEMEC in São Paulo capital?

    No. This campus is São Bernardo do Campo. CEPIC, CPCLIN, and CPQuali remain São Paulo-capital strings.

    Why DEVICE n=0?

    That is the leftover-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=26 is still not ANVISA authorization.

    Did bioaccess® run NCT03057951?

    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 Brazil. São Paulo sibling (do not merge): CEPIC.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital São Vicente de Paulo: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and 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 São Vicente de Paulo as a bioaccess® client.

    If you searched Hospital São Vicente de Paulo Passo Fundo first-in-human, Hospital Sao Vicente de Paulo clinical trial, Passo Fundo CRO Brazil, or “go direct Hospital São Vicente de Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Hospital São Vicente de Paulo in Passo Fundo, Brazil, is a real named hospital string on ClinicalTrials.gov. Passo Fundo is not Porto Alegre and not Campinas. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the Passo Fundo hospital. Distinct from Hospital São Lucas da PUCRS (CMS 95636, Porto Alegre) and from Centro de Pesquisa Sao Lucas in Campinas (this batch). Sharing “Lucas” or sharing Rio Grande do Sul 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital São Vicente de Paulo (Passo Fundo, Brazil) — leftover ranking / canonical accented NCT string: ALL interventional n=26; DEVICE n=0. Example NCT IDs: NCT01897532, NCT02576574, NCT02616068. JSONL confirm (1 September 2026 dump): unique NCT IDs n=26 on the Passo Fundo city string.
    • Unaccented alias Hospital Sao Vicente de Paulo: ALL n=21. Listed separately. Same slug. We do not invent a unique-study union of 26+21. We do not ship a second slug for the unaccented spelling.

    Cite leftover ALL n=26 and DEVICE n=0 on the canonical accented string. Cite unaccented ALL n=21 separately. Do not add them.

    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 São Vicente de Paulo Passo Fundo clinical trial” or the unaccented spelling finds leftover ALL n=26 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on PUCRS São Lucas or Campinas São Lucas. Passo Fundo is still not Porto Alegre. A named hospital is still a site. An NCT location row is not a CRO.

    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 Passo Fundo is not a PUCRS São Lucas file and is not a Campinas São Lucas 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the hospital

    Hospital São Vicente de Paulo in Passo Fundo is a serious named hospital on the public registry. ALL n=26 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into PUCRS São Lucas or into Centro de Pesquisa Sao Lucas Campinas. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital São Vicente de Paulo directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Hospital São Lucas da PUCRS or Centro de Pesquisa Sao Lucas Campinas?

    No. PUCRS São Lucas is CMS 95636 in Porto Alegre. Campinas São Lucas is a separate slug in this batch. This page is Hospital São Vicente de Paulo, Passo Fundo only. Unaccented ALL n=21 stays listed separately; we do not union.

    Should I add leftover ALL n=26 and the unaccented ALL n=21?

    No. Alias n is listed separately. A unique-study union is not published. The unaccented spelling is the same Passo Fundo campus on the same slug.

    Is this PUCRS São Lucas?

    No. Hospital São Lucas da PUCRS is Porto Alegre (CMS 95636). This page is Passo Fundo.

    Is this Centro de Pesquisa Sao Lucas in Campinas?

    No. That is a Campinas research-center string in this batch. Passo Fundo is a different city and a different NCT string.

    Did bioaccess® run NCT01897532?

    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 Brazil. Porto Alegre sibling (do not merge): Hospital São Lucas da PUCRS.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Cardiológica Aguascalientes: 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 Hospital Cardiológica Aguascalientes as a bioaccess® client.

    If you searched Hospital Cardiologica Aguascalientes first-in-human, Hospital Cardiológica Aguascalientes clinical trial, Aguascalientes cardiology CRO, or “go direct Hospital Cardiológica Aguascalientes,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Cardiologica Aguascalientes in Aguascalientes, Mexico, is a real named cardiology-hospital string on ClinicalTrials.gov. Aguascalientes is not Mexico City. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

    This page is the Aguascalientes cardiology hospital. It is not Instituto Nacional de Cardiología Ignacio Chávez in Mexico City. Different city. Different NCT string. Sharing “cardiológica” in a hospital 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Cardiologica Aguascalientes (Aguascalientes, Mexico) — leftover ranking / canonical NCT string: ALL interventional n=26. Example NCT IDs: NCT01975389, NCT02019264, NCT02104947. JSONL confirm (1 September 2026 dump): unique NCT IDs n=26 on this city string. DEVICE n=0 on the leftover table. JSONL did not force a DEVICE n; we will not invent one.
    • Typo alias Hospital Cardiologica Aguescalientes: ALL n=4. Listed separately. Same slug. We do not invent a unique-study union of 26+4. We do not ship a second slug for the typo.

    Cite leftover ALL n=26 as the ranking row. Cite typo-alias ALL n=4 separately. Do not add them. Do not invent a DEVICE n.

    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 Cardiológica Aguascalientes clinical trial” or the Aguescalientes typo finds leftover ALL n=26 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on Instituto Nacional de Cardiología Ignacio Chávez in Mexico City. Aguascalientes is still not Mexico City. A named cardiology hospital is still a site. An NCT location row is not a CRO.

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

    A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation in Aguascalientes is not an Ignacio Chávez Mexico City file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

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

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

    Do not smear the hospital

    Hospital Cardiologica Aguascalientes is a serious named Aguascalientes cardiology resource on the public registry. ALL n=26 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Instituto Nacional de Cardiología Ignacio Chávez. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Cardiológica Aguascalientes directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Instituto Nacional de Cardiología Ignacio Chávez?

    No. Ignacio Chávez is a Mexico City national cardiology institute. This page is Hospital Cardiologica Aguascalientes only. The Aguescalientes typo stays on this slug; we list ALL n=4 separately and do not union.

    Should I add leftover ALL n=26 and the typo ALL n=4?

    No. Alias n is listed separately. A unique-study union is not published. The typo is the same Aguascalientes campus on the same slug.

    Why no DEVICE n?

    DEVICE n=0 on the leftover table. JSONL did not force a DEVICE n for this string. We will not invent one. ALL n=26 is still not COFEPRIS authorization.

    Is Aguascalientes under a different national agency than Mexico City?

    No. COFEPRIS is still the national file. Ethics typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. Registro sanitario (~30 working days) is a different file.

    Did bioaccess® run NCT01975389?

    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®

  • Scientia Investigación Clínica Chihuahua: 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 Scientia Investigación Clínica Chihuahua as a bioaccess® client.

    If you searched Scientia Investigacion Clinica Chihuahua first-in-human, Scientia Investigación Clínica S.C. clinical trial, Chihuahua CRO Mexico, or “go direct Scientia Investigación Clínica Chihuahua,” you followed a campus string ClinicalTrials.gov still publishes. Scientia Investigacion Clinica S.C. in Chihuahua City, Mexico, is a real named research-clinic string on ClinicalTrials.gov. 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 Chihuahua City named research clinic. Distinct from INCan (CMS 95655), INCMNSZ Salvador Zubirán (CMS 95623), Centro de Investigación Clínica de Oaxaca (CMS 95664), FAICIC Veracruz (CMS 95670), Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646), and Hospital Universitario Dr. José Eleuterio González (CMS 95643). Chihuahua City is not Mexico City, not Oaxaca, not Veracruz, not Guadalajara, not Monterrey, and not Estado de México.

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

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

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Scientia Investigacion Clinica S.C. (Chihuahua City, Mexico) — leftover ranking / canonical NCT string: ALL interventional n=26; DEVICE n=1. Example NCT IDs: NCT03518086, NCT03519945, NCT03524092. JSONL confirm (1 September 2026 dump): unique NCT IDs n=26 on the Chihuahua City string.

    Cite leftover ALL n=26 and DEVICE n=1 as given. We do not invent a second Chihuahua slug. We do not merge this clinic into a Mexico City national institute.

    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 “Scientia Chihuahua clinical trial” or “Scientia Investigación Clínica FIH” finds leftover ALL n=26 (DEVICE n=1) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCan, INCMNSZ, Oaxaca, FAICIC, Guadalajara, or Eleuterio González. A named Chihuahua 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 typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation in Chihuahua City is not an INCMNSZ or FAICIC file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

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

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

    Do not smear the clinic

    Scientia Investigacion Clinica S.C. is a serious named Chihuahua research clinic on the public registry. ALL n=26 (DEVICE n=1) is registry volume, not a punchline. Do not merge it into INCan, INCMNSZ, Oaxaca, FAICIC, Guadalajara, or Eleuterio González. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Scientia Investigación Clínica Chihuahua 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 intercepts the search; it does not claim the studies.

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

    No. INCan is CMS 95655 (Mexico City). INCMNSZ is CMS 95623 (Mexico City). Oaxaca is CMS 95664. FAICIC is CMS 95670 (Veracruz). Hospital Civil Guadalajara is CMS 95646. Eleuterio González is CMS 95643 (Monterrey). This page is Scientia Investigacion Clinica S.C., Chihuahua City only.

    Is Chihuahua under a different national agency than Mexico City?

    No. COFEPRIS is still the national file. Ethics typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. 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. DEVICE n is unique NCT IDs on the device filter for this facility string. It is not COFEPRIS authorization, not import, and not a 21 CFR 812.28 package.

    Is Chihuahua the same campus as a Mexico City national institute?

    No. INCan and INCMNSZ remain Mexico City strings. This page is Chihuahua City only.

    Did bioaccess® run NCT03518086?

    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®

  • A.C. Camargo Cancer Center: 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 A.C. Camargo Cancer Center as a bioaccess® client.

    If you searched A.C. Camargo Cancer Center first-in-human, Fundacao Antonio Prudente clinical trial, AC Camargo São Paulo CRO, or “go direct A.C. Camargo Cancer Center,” you followed a campus string ClinicalTrials.gov still publishes. Fundacao Antonio Prudente A C Camargo Cancer Center in São Paulo, Brazil, is a real named cancer-center string on ClinicalTrials.gov. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Fundação Antonio Prudente / A.C. Camargo campus. Distinct from ICESP (CMS 95642), Barretos Cancer Hospital (CMS 95648), Hospital Sírio-Libanês (CMS 95676), and Hospital Israelita Albert Einstein (CMS 95621). Sharing São Paulo or sharing an oncology search 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Fundacao Antonio Prudente A C Camargo Cancer Center (São Paulo, Brazil) — leftover ranking / canonical NCT string: ALL interventional n=26; DEVICE n=1. Example NCT IDs: NCT03390504, NCT03748641, NCT03871829. JSONL confirm (1 September 2026 dump): unique NCT IDs n=26 on this canonical string.
    • Alias AC Camargo Cancer Center: ALL n=20. Listed separately. Same slug. No union.
    • Alias A. C. Camargo Cancer Center: ALL n=14. Listed separately. Same slug. No union.
    • Alias A.C. Camargo Cancer Center: ALL n=9. Listed separately. Same slug. No union.

    Cite leftover ALL n=26 and DEVICE n=1 on the canonical string. Cite each alias n separately. Do not add 26+20+14+9. We do not ship a second slug for punctuation variants.

    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 “A.C. Camargo first-in-human” or “Fundacao Antonio Prudente clinical trial” finds leftover ALL n=26 (DEVICE n=1) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, Sírio-Libanês, or Einstein. A named cancer center is still a site. An NCT location row is 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:

    • 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 A.C. Camargo is not an ICESP, Barretos, Sírio, or Einstein 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the center

    A.C. Camargo Cancer Center is a serious named São Paulo cancer center on the public registry. ALL n=26 (DEVICE n=1) is registry volume, not a punchline. Do not merge it into ICESP, Barretos, Sírio-Libanês, or Einstein. Do not union alias n. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract A.C. Camargo Cancer Center 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 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 center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as ICESP, Barretos, Sírio-Libanês, or Einstein?

    No. ICESP is CMS 95642. Barretos is CMS 95648. Sírio-Libanês is CMS 95676. Einstein is CMS 95621. This page is Fundacao Antonio Prudente A C Camargo Cancer Center only. Alias n stays listed separately; we do not union.

    Should I add ALL n=26, 20, 14, and 9?

    No. Alias n is listed separately. A unique-study union is not published. Punctuation variants of A.C. Camargo stay on this slug.

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

    No. DEVICE n is unique NCT IDs on the device filter for the canonical facility string. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023. An NCT location row is not that file.

    Is this ICESP or Barretos?

    No. ICESP is CMS 95642 in São Paulo. Barretos is CMS 95648. Sharing oncology is not a merge.

    Did bioaccess® run NCT03390504?

    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 Brazil. São Paulo sibling (do not merge): ICESP.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Neurologia de Curitiba: 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 Instituto de Neurologia de Curitiba as a bioaccess® client.

    If you searched Instituto de Neurologia de Curitiba first-in-human, INC Curitiba clinical trial, neurology institute Curitiba CRO, or “go direct Instituto de Neurologia de Curitiba,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Neurologia de Curitiba in Curitiba, Brazil, is a real named neurology-institute string on ClinicalTrials.gov. 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Curitiba neurology institute. Distinct from Hospital Erasto Gaertner (CMS 95656) — same city, oncology hospital, different NCT string. Sharing Curitiba 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; complete dump), this campus sits here after filters:

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Instituto de Neurologia de Curitiba (Curitiba, Brazil) — leftover ranking row: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT00988429, NCT03085810, NCT03114657.
    • JSONL confirm on the same named campus string (1 September 2026 all_interventional dump): unique NCT IDs n=28. That is the same campus string, not a second institute. Cite leftover ALL n=27 as the ranking table. Cite JSONL n=28 only as the same-string confirm. Do not treat 27 and 28 as two campuses. Do not invent a union with any other Curitiba hospital.

    Prefer leftover ALL n=27 with the CoS NCT IDs above as the ranking cite. DEVICE n=0 on the leftover table; we will not pad it.

    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 de Neurologia de Curitiba clinical trial” or “INC Curitiba FIH” finds leftover ALL n=27 (JSONL same-string n=28) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Erasto Gaertner. A named neurology 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:

    • 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 this neurology institute is not an Erasto Gaertner oncology-hospital 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the institute

    Instituto de Neurologia de Curitiba is a serious named Curitiba neurology resource on the public registry. Leftover ALL n=27 is registry volume, not a punchline. JSONL n=28 is the same campus string confirm, not a second hospital. Do not invent a DEVICE n. Do not merge it into Erasto Gaertner. Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Instituto de Neurologia de Curitiba 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 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 institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Hospital Erasto Gaertner?

    No. Erasto Gaertner is CMS 95656, a Curitiba oncology hospital. This page is Instituto de Neurologia de Curitiba only. Leftover ALL n=27 is the ranking row; JSONL n=28 is the same named string, not a merge with Erasto.

    Why leftover ALL n=27 and JSONL n=28?

    The leftover ranking table uses facility string + city + country (Curitiba). The JSONL named-string confirm is n=28 on the same campus string. Cite leftover ALL n=27 as the ranking table. Cite JSONL n=28 as the same-string confirm. They are not two institutes.

    Is this Erasto Gaertner?

    No. Erasto Gaertner is a different Curitiba hospital and a different NCT string (CMS 95656). Oncology versus neurology-institute string is not a merge.

    Why DEVICE n=0?

    That is the leftover-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANVISA authorization.

    Did bioaccess® run NCT00988429?

    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 Brazil. Curitiba sibling (do not merge): Hospital Erasto Gaertner.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centro de Pesquisa São Lucas Campinas: 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 Centro de Pesquisa São Lucas Campinas as a bioaccess® client.

    If you searched Centro de Pesquisa Sao Lucas first-in-human, São Lucas Campinas clinical trial, Centro de Pesquisa São Lucas CRO Brazil, or “go direct Centro de Pesquisa São Lucas Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Pesquisa Sao Lucas in Campinas, Brazil, is a real named research-center string on ClinicalTrials.gov. Campinas 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the Campinas named research center. Distinct from Hospital São Lucas da PUCRS (CMS 95636, Porto Alegre). It is also not Hospital São Vicente de Paulo in Passo Fundo (this batch). Sharing “São Lucas” in another city is not a license to collapse them. Campinas versus Porto Alegre is the whole point of the intercept.

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

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

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Centro de Pesquisa Sao Lucas (Campinas, Brazil) — leftover ranking row / canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT03899259, NCT04211337, NCT04232553. JSONL confirm (1 September 2026 all_interventional dump, 17497 studies): unique NCT IDs on this Campinas string n=27.
    • Accented alias Centro de Pesquisa São Lucas (Campinas): ALL n=4. Listed separately. Same slug. We do not invent a unique-study union of 27+4. We do not ship a second slug for the accented spelling.

    Cite leftover ALL n=27 and DEVICE n=0 on the canonical string. Cite alias ALL n=4 separately. Do not add them. We will not invent a DEVICE n.

    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 “Centro de Pesquisa São Lucas Campinas clinical trial” or “São Lucas FIH Brazil” finds leftover ALL n=27 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital São Lucas da PUCRS in Porto Alegre. Campinas is still not Porto Alegre. A named research center is still a site. An NCT location row is 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:

    • 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 Campinas is not a PUCRS São Lucas 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-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Do not smear the center

    Centro de Pesquisa Sao Lucas in Campinas is a serious named research center on the public registry. ALL n=27 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Hospital São Lucas da PUCRS (Porto Alegre) or into Hospital São Vicente de Paulo (Passo Fundo). Do not invent a PI. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Centro de Pesquisa São Lucas Campinas 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 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 center. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Hospital São Lucas da PUCRS or Hospital São Vicente de Paulo Passo Fundo?

    No. Hospital São Lucas da PUCRS is CMS 95636 in Porto Alegre. Hospital São Vicente de Paulo is a Passo Fundo slug in this batch. This page is Centro de Pesquisa Sao Lucas, Campinas only. The accented alias ALL n=4 stays listed separately; we do not union.

    Should I add leftover ALL n=27 and the accented ALL n=4?

    No. Alias n is listed separately. A unique-study union is not published. The accented spelling is the same Campinas campus on the same slug.

    Is this Hospital São Lucas da PUCRS?

    No. PUCRS São Lucas is Porto Alegre (CMS 95636). This page is Campinas. City is the filter.

    Why DEVICE n=0?

    That is the leftover-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANVISA authorization.

    Did bioaccess® run NCT03899259?

    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 Brazil. Porto Alegre sibling (do not merge): Hospital São Lucas da PUCRS.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Conde de Valenciana: The Press-Named Institute 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 Instituto de Oftalmología Conde de Valenciana as a bioaccess® client.

    If you searched Conde de Valenciana first-in-human, Instituto de Oftalmología Fundación Conde de Valenciana clinical trial, GORE synthetic cornea Mexico City, Arturo Ramírez Miranda, or “go direct Instituto de Oftalmología Conde de Valenciana,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oftalmología Conde de Valenciana in Mexico City is a real named ophthalmology institute. FAP / Fundación spellings are the same campus on this slug. 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

    This page is forced into this batch (press rank 13, mention_n=1) even though ALL n sits below the NCT cutoff for ranks 1-9. Distinct from CODET Vision Institute Tijuana, UNAM Optometry Clinic (CMS 95658), Panama Eye Centre, and The Panama Clinic (CMS 95513). Arturo Ramírez Miranda, MD, is the press-named investigator on the Conde item, not a second facility slug.

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

    Device press writes the implant, the city, the institute, and the surgeon. Device registries write a smaller NCT campus string. Neither writes the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep this campus sits on a small ALL n. On the same-day press sweep it is rank 13, mention_n=1. Those are different files:

    Counts come from /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Instituto de Oftalmología Conde de Valenciana (Mexico City, Mexico) — canonical NCT string: ALL interventional n=4; DEVICE n=1. Example NCT IDs: NCT04648085, NCT06159881, NCT06477081.
    • FAP / Fundación spelling aliases (including Instituto de Oftalmología Fundación Conde de Valenciana) are the same campus. Same slug. No second n. No unique-study union.
    • Press mention_n=1: Cornea / PMC 2025 GORE synthetic cornea early-feasibility methods name Instituto de Oftalmología Fundación Conde de Valenciana as the 2024 implant site. Press-named PI: Arturo Ramírez Miranda, MD. The same item log also prints NCT06174376 in that paper. We cite the URL as press evidence. We do not add NCT06174376 into ALL n=4. We do not invent more investigators. We do not ship a PI-person slug.

    Cite ALL n=4 and DEVICE n=1 as given. Cite press mention_n=1 as given. Do not union NCT n with press n.

    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 Conde de Valenciana first-in-human or Arturo Ramírez Miranda finds a named Mexico City institute without finding COFEPRIS, import, insurance, or 21 CFR 812.28. A methods paper is not a CRO. We will not claim bioaccess® ran the GORE synthetic cornea EFS. We will not claim Conde as a bioaccess® client.

    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:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation at Conde de Valenciana is not a CODET Tijuana file and is not a Panama eye-clinic file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How COFEPRIS actually works (the short version)

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

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

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

    Do not smear the institute

    Instituto de Oftalmología Conde de Valenciana is a serious Mexico City ophthalmology resource. ALL n=4 (DEVICE n=1) plus one public methods paper is public volume, not a punchline. Do not smear the institute. Do not merge it into CODET, UNAM optometry, Panama Eye Centre, or The Panama Clinic. Do not treat Arturo Ramírez Miranda, MD, as a second facility. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Instituto de Oftalmología Conde de Valenciana 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 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 institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as CODET Tijuana, UNAM optometry, Panama Eye Centre, or The Panama Clinic?

    No. CODET is the Tijuana ophthalmic intercept. UNAM optometry is CMS 95658. Panama Eye Centre and The Panama Clinic (CMS 95513) are Panama. This page is Instituto de Oftalmología Conde de Valenciana, Mexico City only. FAP / Fundación spellings stay here. Arturo Ramírez Miranda, MD, is cited as press-named PI on this campus, not as a second slug.

    Did bioaccess® run the GORE synthetic cornea EFS?

    No. The Cornea / PMC 2025 methods paper names the institute as the 2024 implant site. No public bioaccess® case-study page names this program. We will not invent that claim.

    Is Arturo Ramírez Miranda a second campus?

    No. He is the press-named PI on the Conde item. We do not invent more investigators. We do not publish a PI-person-as-facility slug.

    Should I add NCT06174376 into ALL n=4?

    No. ALL n=4 is the ClinicalTrials.gov facility-string count. NCT06174376 is cited because the press item prints it. That is press citation, not a union.

    Is Fundación / FAP Conde a different campus?

    No. Same Mexico City campus. Same slug. No second n. No union. Not CODET Tijuana.

    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. Tijuana sibling (do not merge): CODET Vision Tijuana FIH.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centro de Investigaciones Clínicas del Litoral: 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 Centro de Investigaciones Clínicas del Litoral as a bioaccess® client.

    If you searched Centro de Investigaciones Clinicas del Litoral first-in-human, CIC Litoral Santa Fe clinical trial, Santa Fe Argentina CRO, or “go direct Centro de Investigaciones Clínicas del Litoral,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Clínicas del Litoral in Santa Fe city, Argentina, is a real named research-clinic string on ClinicalTrials.gov. This page is Santa Fe city, Argentina — not Rosario, and not Itajaí, Brazil. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the Santa Fe city named research clinic. Distinct from Rosario campuses: Hospital Provincial del Centenario (CMS 95649), INECO Neurociencias Oroño (CMS 95663), and Fundación Estudios Clínicos (this batch). It is not Clínica de Neoplasias Litoral in Itajaí, Brazil (a different country and a different NCT string). Sharing “Litoral” 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; complete dump), this campus sits here after filters:

    Counts come from /workspace/five-trials/kill-page-batch-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Centro de Investigaciones Clinicas del Litoral (Santa Fe, Argentina) — canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT00389779, NCT00900146, NCT03547583.

    Cite ALL n=27 as given. We will not invent a DEVICE n. DEVICE n=0 on the picks table; we will not pad it.

    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 “Centro de Investigaciones Clínicas del Litoral Santa Fe clinical trial” finds ALL n=27 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Centenario Rosario, INECO, Estudios Clínicos, or an Itajaí oncology clinic. A named Santa Fe city 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:

    • 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 Santa Fe city is not a Rosario file and is not a Brazilian Litoral file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANMAT actually works (the short version)

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

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

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

    Do not smear the clinic

    Centro de Investigaciones Clínicas del Litoral is a serious named Santa Fe city research clinic on the public registry. ALL n=27 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Rosario Centenario, INECO, or Estudios Clínicos. Do not smear it by confusing it with Clínica de Neoplasias Litoral in Itajaí, Brazil. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Centro de Investigaciones Clínicas del Litoral 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 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Centenario Rosario, INECO, Fundación Estudios Clínicos, or Clínica de Neoplasias Litoral Itajaí?

    No. Centenario is CMS 95649 (Rosario). INECO is CMS 95663 (Rosario). Fundación Estudios Clínicos is a Rosario slug in this batch. Clínica de Neoplasias Litoral is Itajaí, Brazil — not this page and not this country. This page is Centro de Investigaciones Clínicas del Litoral, Santa Fe city, Argentina only.

    Is Santa Fe city the same as Rosario for this string?

    No. Rosario campuses (Centenario, INECO, Estudios Clínicos) stay on their own slugs. This NCT string is Santa Fe city, Argentina.

    Is this Clínica de Neoplasias Litoral in Itajaí?

    No. That is Brazil. This page is an Argentine research clinic. Sharing “Litoral” is not a merge.

    Why DEVICE n=0?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANMAT authorization.

    Did bioaccess® run NCT00389779?

    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. Rosario sibling (do not merge): Hospital Provincial del Centenario.

    Julio G. Martinez-Clark, CEO · bioaccess®