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Category: Advantages of Conducting Trials in Latin America

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

  • University of 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 University of Campinas as a bioaccess® client.

    If you searched University of Campinas first-in-human, UNICAMP clinical trial, Universidade Estadual de Campinas CRO, or “go direct University of Campinas,” you followed a campus string ClinicalTrials.gov still publishes. University of Campinas (UNICAMP) in Campinas, Brazil, is a real named university 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 university is the site. The First-in-Human CRO still owns ANVISA/CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the UNICAMP university NCT string. It is not Centro de Pesquisa São Lucas Campinas (CMS 95689). Sharing Campinas is not a license to collapse them. Piracicaba Dental School is a school campus of the same university system, not this slug. Aliases Universidade Estadual de Campinas and short UNICAMP stay on this slug; we do not ship second slugs.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • University of Campinas (Campinas, Brazil) — canonical NCT string: ALL interventional n=23; DEVICE n=4. Example NCT IDs: NCT00787553, NCT01032798, NCT01125254.
    • Alias Universidade Estadual de Campinas (Campinas): ALL n=14. Listed separately. Same slug. No union.
    • Alias UNICAMP (Campinas): ALL n=2. Listed separately. Same slug. No union.

    Cite canonical ALL n=23 and DEVICE n=4. Cite each alias n separately. Do not add 23+14+2. DEVICE n=4 is the highest DEVICE among remaining ALL=23 rows in this pick table; we will not invent extra DEVICE IDs. Piracicaba Dental School is not this slug.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

    That is the leak: a founder searching “UNICAMP first-in-human” or “University of Campinas clinical trial” finds canonical ALL n=23 (DEVICE n=4) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Centro de Pesquisa São Lucas Campinas or on Piracicaba Dental School as a second hospital slug. A named university string is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation on the UNICAMP university string is not a São Lucas Campinas research-center file and is not a Piracicaba Dental School 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 university

    University of Campinas is a serious named university on the public registry. ALL n=23 and DEVICE n=4 are registry volume, not a punchline. Do not merge it into Centro de Pesquisa São Lucas Campinas. Do not republish Piracicaba Dental School as this slug. 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 University of Campinas directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Centro de Pesquisa São Lucas Campinas or Piracicaba Dental School?

    No. São Lucas Campinas is CMS 95689, a named research-center string. Piracicaba Dental School is a school campus, not this slug. Universidade Estadual de Campinas ALL n=14 and UNICAMP ALL n=2 stay listed separately on this page; we do not union.

    Should I add ALL n=23, Universidade Estadual n=14, and UNICAMP n=2?

    No. Alias n is listed separately. A unique-study union is not published. Portuguese and short strings stay on this slug.

    Is this Centro de Pesquisa São Lucas Campinas?

    No. São Lucas Campinas is CMS 95689. This page is the University of Campinas / UNICAMP university string.

    Is Piracicaba Dental School this page?

    No. Piracicaba Dental School is a school campus, not this slug. We do not ship it as a second UNICAMP hospital intercept here.

    Did bioaccess® run NCT00787553?

    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. Campinas sibling (do not merge): Centro de Pesquisa São Lucas Campinas.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Medical Care and Research Mérida: 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 Medical Care and Research Mérida as a bioaccess® client.

    If you searched Medical Care and Research Merida first-in-human, Medical Care and Research SA de CV clinical trial, Mérida CRO Mexico, or “go direct Medical Care and Research Mérida,” you followed a campus string ClinicalTrials.gov still publishes. Medical Care and Research SA de CV in Mérida, Yucatán, Mexico, is a real named research-clinic string on ClinicalTrials.gov. This is the first Mérida slug in this intercept series. 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 named Mérida clinic. It is not Oaxaca (CMS 95664), not FAICIC Veracruz (CMS 95670), not Scientia Chihuahua (CMS 95692), not Clinical Research Institute Tlalnepantla (CMS 95683), not INCMNSZ (CMS 95623), and not INCan (CMS 95655). Sharing a Mexican research-clinic search is not a license to collapse them. Punctuation alias Medical Care & Research SA de CV stays on this slug; we do not ship a second slug.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Medical Care and Research SA de CV (Mérida, Mexico) — canonical NCT string: ALL interventional n=24; DEVICE n=0. Example NCT IDs: NCT04255433, NCT04365868, NCT05256654.
    • Punctuation alias Medical Care & Research SA de CV (Mérida): ALL n=23. Listed separately. Same slug. We do not invent a unique-study union of 24+23. We do not ship a second slug for the ampersand.

    Cite canonical ALL n=24 and DEVICE n=0. Cite alias ALL n=23 separately. Do not add them. We will not invent a DEVICE n. First Mérida slug.

    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 “Medical Care and Research Mérida clinical trial” or “Medical Care and Research SA de CV FIH” finds canonical ALL n=24 (DEVICE n=0) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Oaxaca, FAICIC, Scientia, CRI Tlalnepantla, INCMNSZ, or INCan. A named 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:

    • 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 Mérida is not an Oaxaca, FAICIC, Scientia, Tlalnepantla, INCMNSZ, or INCan 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

    Medical Care and Research SA de CV is a serious named Mérida research clinic on the public registry. ALL n=24 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Oaxaca, FAICIC, Scientia, CRI Tlalnepantla, INCMNSZ, or INCan. 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 Medical Care and Research Mérida 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 Oaxaca, FAICIC, Scientia Chihuahua, CRI Tlalnepantla, INCMNSZ, or INCan?

    No. Oaxaca is CMS 95664. FAICIC is CMS 95670. Scientia is CMS 95692. CRI Tlalnepantla is CMS 95683. INCMNSZ is CMS 95623. INCan is CMS 95655. This page is Medical Care and Research, Mérida only. Ampersand alias ALL n=23 stays listed separately; we do not union. First Mérida slug.

    Should I add canonical ALL n=24 and ampersand alias ALL n=23?

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

    Is this INCMNSZ or INCan?

    No. Those are Mexico City national-institute intercepts. This page is Mérida, Yucatán.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=24 is still not COFEPRIS authorization. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median start-up on the Mexico hub; registro ~30 working days.

    Did bioaccess® run NCT04255433?

    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. Mexico City sibling (do not merge): INCMNSZ. Chihuahua sibling: Scientia Chihuahua.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Oncología de Rosario: The NCT Campus String Is Not the ANMAT File

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

    If you searched Instituto de Oncologia de Rosario first-in-human, Instituto de Oncología Rosario clinical trial, IOR Rosario CRO, or “go direct Instituto de Oncología de Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oncología de Rosario in Rosario, Argentina, is a real named oncology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

    This page is the named Rosario oncology institute. It is not Hospital Provincial del Centenario (CMS 95649), not INECO (CMS 95663), not Fundación de Estudios Clínicos Rosario (CMS 95680), not Sanatorio Parque (CMS 95666), not ICESP (CMS 95642), not Barretos (CMS 95648), not A.C. Camargo (CMS 95691), and not CORI (CMS 95672). Sharing Rosario or sharing an oncology search is not a license to collapse them. Unaccented Instituto de Oncologia de Rosario is a spelling alias on this slug, not a second slug.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Instituto de Oncología de Rosario (Rosario, Argentina) — canonical NCT string: ALL interventional n=24; DEVICE n=0. Example NCT IDs: NCT01026142, NCT01572038, NCT01641939.
    • Unaccented alias Instituto de Oncologia de Rosario: ALL n=22. Listed separately. Same slug. We do not invent a unique-study union of 24+22. We do not ship a second slug for the missing accent.

    Cite canonical ALL n=24 and DEVICE n=0. Cite unaccented ALL n=22 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 institute as a client site.

    That is the leak: a founder searching “Instituto de Oncología de Rosario clinical trial” or “IOR Rosario FIH” finds canonical ALL n=24 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. A named oncology institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at this Rosario institute is not a Centenario, INECO, Estudios Clínicos, Parque, ICESP, Barretos, Camargo, or CORI 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 institute

    Instituto de Oncología de Rosario is a serious named Rosario oncology resource on the public registry. ALL n=24 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. 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 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 Instituto de Oncología de Rosario directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Centenario, INECO, Estudios Clínicos Rosario, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI?

    No. Centenario is CMS 95649. INECO is CMS 95663. Estudios Clínicos Rosario is CMS 95680. Sanatorio Parque is CMS 95666. ICESP is CMS 95642. Barretos is CMS 95648. Camargo is CMS 95691. CORI is CMS 95672. This page is Instituto de Oncología de Rosario only. Unaccented ALL n=22 stays listed separately; we do not union.

    Should I add canonical ALL n=24 and unaccented ALL n=22?

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

    Is this ICESP, Barretos, or A.C. Camargo?

    No. Those are Brazilian oncology intercepts already live. This page is Rosario, Argentina.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=24 is still not ANMAT authorization.

    Did bioaccess® run NCT01026142?

    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. Rosario sibling (do not merge): Fundación de Estudios Clínicos Rosario. São Paulo oncology sibling (do not merge): A.C. Camargo.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital São Rafael: 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 Rafael as a bioaccess® client.

    If you searched Hospital Sao Rafael first-in-human, Hospital São Rafael Salvador clinical trial, HSR Salvador CRO, or “go direct Hospital São Rafael,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Sao Rafael in Salvador, 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 Salvador hospital. It is not Núcleo de Oncologia da Bahia (different NCT string, same city — leftover, not this page). Sharing Salvador is not a license to collapse them. Alias Hospital Sao Rafael – HSR stays on this slug; we do not ship a second slug.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Sao Rafael (Salvador, Brazil) — canonical NCT string: ALL interventional n=24; DEVICE n=2. Example NCT IDs: NCT00340834, NCT02003924, NCT03165734.
    • Alias Hospital Sao Rafael – HSR (Salvador): ALL n=20. Listed separately. Same slug. We do not invent a unique-study union of 24+20. We do not ship a second slug for the HSR suffix.

    Cite canonical ALL n=24 and DEVICE n=2. Cite alias ALL n=20 separately. Do not add them. DEVICE n=2 edges other ALL=24 rows; we will not invent extra DEVICE IDs.

    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 Rafael Salvador clinical trial” or “HSR Salvador FIH” finds canonical ALL n=24 (DEVICE n=2) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Núcleo de Oncologia da Bahia. 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 at Hospital São Rafael is not a Núcleo de Oncologia da Bahia 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 Sao Rafael is a serious named Salvador hospital on the public registry. ALL n=24 and DEVICE n=2 are registry volume, not a punchline. Do not merge it into Núcleo de Oncologia da Bahia. 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 Rafael 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 Núcleo de Oncologia da Bahia?

    No. Núcleo de Oncologia da Bahia is a different NCT string in the same city and is leftover, not this page. Alias Hospital Sao Rafael – HSR ALL n=20 stays listed separately on this slug; we do not union.

    Should I add canonical ALL n=24 and HSR alias ALL n=20?

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

    Is this Núcleo de Oncologia da Bahia?

    No. That is a different NCT string in Salvador. Same city is not the same hospital. It is leftover, not this page.

    Why DEVICE n=2?

    That is the ranking-table DEVICE count for the canonical string. It edges other ALL=24 rows. It is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 as published on the Brazil country page.

    Did bioaccess® run NCT00340834?

    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.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • IBPClin: 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 IBPClin as a bioaccess® client.

    If you searched IBPClin first-in-human, Instituto Brasil de Pesquisa Clínica clinical trial, IBPClin Rio CRO, or “go direct IBPClin,” you followed a campus string ClinicalTrials.gov still publishes. IBPClin — Instituto Brasil de Pesquisa Clínica in Rio de Janeiro, Brazil, is a real named investigative-institute string on ClinicalTrials.gov. This is the first Rio de Janeiro clinic slug in this intercept series. 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 Rio investigative institute. It is not CEPIC (CMS 95662), not CPQuali (CMS 95671), not CPCLIN (CMS 95684), and not CEMEC (CMS 95695). It is not Universidade Federal do Rio de Janeiro (this batch, a university string on a different slug). Sharing a Rio de Janeiro search or sharing a “pesquisa clínica” token 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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • IBPClin – Instituto Brasil de Pesquisa Clínica (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT03899259, NCT03952559, NCT04255433.

    Cite canonical ALL n=25 and DEVICE n=0. We will not invent an alias union with UFRJ. We will not invent a DEVICE n. First Rio clinic slug; UFRJ stays on its own slug in this batch.

    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 “IBPClin Rio first-in-human” or “Instituto Brasil de Pesquisa Clínica clinical trial” finds canonical ALL n=25 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. A named research 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 IBPClin is not a CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ 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

    IBPClin is a serious named Rio investigative institute on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. 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 IBPClin 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 CEPIC, CPQuali, CPCLIN, CEMEC, or Universidade Federal do Rio de Janeiro?

    No. CEPIC is CMS 95662. CPQuali is CMS 95671. CPCLIN is CMS 95684. CEMEC is CMS 95695. UFRJ is a different Rio university string in this batch. This page is IBPClin only. First Rio clinic slug.

    Is this UFRJ?

    No. Universidade Federal do Rio de Janeiro is a university NCT string on its own slug in this batch. IBPClin is a named investigative institute. Rio is not a merge key.

    Is this CEPIC, CPQuali, CPCLIN, or CEMEC?

    No. Those are already-live research-center intercepts in other Brazilian cities. This page is IBPClin, Rio de Janeiro.

    Why DEVICE n=0?

    That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=25 is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.

    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. São Paulo research-center sibling (do not merge): CPCLIN.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Privado Centro Médico de Córdoba: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Privado Centro Médico de Córdoba as a bioaccess® client.

    If you searched Hospital Privado Centro Medico de Cordoba first-in-human, Hospital Privado Córdoba clinical trial, Centro Médico Córdoba CRO, or “go direct Hospital Privado Centro Médico de Córdoba,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Privado Centro Medico de Cordoba in Córdoba, Argentina, is a real named private-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

    This page is the named Córdoba private hospital. It is not Sanatorio Allende (CMS 95645), not Hospital San Roque Córdoba (CMS 95686), and not Instituto Médico Río Cuarto (CMS 95679). Sharing Córdoba or sharing a private-hospital search is not a license to collapse them. Río Cuarto is a different city.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Privado Centro Medico de Cordoba (Córdoba, Argentina) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00071331, NCT00232596, NCT00310375.

    Cite canonical ALL n=25 and DEVICE n=0. We will not invent an alias union. We will not invent a DEVICE n. We do not ship Allende or San Roque as this slug.

    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 Privado Córdoba first-in-human” or “Centro Médico de Córdoba clinical trial” finds canonical ALL n=25 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Allende, San Roque Córdoba, or Instituto Médico Río Cuarto. A named private 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:

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

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

    How ANMAT actually works (the short version)

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

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

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

    Do not smear the hospital

    Hospital Privado Centro Medico de Cordoba is a serious named Córdoba private 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 Allende, San Roque Córdoba, or Instituto Médico Río Cuarto. 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 ANMAT / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital Privado Centro Médico de Córdoba directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Sanatorio Allende, Hospital San Roque Córdoba, or Instituto Médico Río Cuarto?

    No. Allende is CMS 95645. San Roque Córdoba is CMS 95686. Instituto Médico Río Cuarto is CMS 95679. This page is Hospital Privado Centro Medico de Cordoba only.

    Is this Sanatorio Allende?

    No. Allende is a different Córdoba campus (CMS 95645). Same city is not the same NCT string.

    Is this Hospital San Roque Córdoba?

    No. San Roque Córdoba is CMS 95686. This page is Hospital Privado Centro Medico de Cordoba.

    Why DEVICE n=0?

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

    Did bioaccess® run NCT00071331?

    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. Córdoba sibling (do not merge): Hospital San Roque Córdoba. Río Cuarto sibling: Instituto Médico Río Cuarto.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Fundación Scherbovsky: 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 Fundación Scherbovsky as a bioaccess® client.

    If you searched Fundacion Scherbovsky first-in-human, Scherbovsky Mendoza clinical trial, Fundación Scherbovsky CRO Argentina, or “go direct Fundación Scherbovsky,” you followed a campus string ClinicalTrials.gov still publishes. Fundacion Scherbovsky in Mendoza, Argentina, is a real named clinical-research-foundation string on ClinicalTrials.gov. This is the first Mendoza slug in this intercept series. 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 foundation 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 foundation still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Mendoza foundation. It is not Sanatorio Allende (CMS 95645, Córdoba), not CORI (CMS 95672, La Rioja), and not CIPREC (CMS 95641). Sharing an Argentine research search is not a license to collapse them. Mendoza is not Córdoba and is not La Rioja.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    Cite canonical ALL n=25 and DEVICE n=0. We will not invent an alias n for this string. We will not invent a DEVICE n. We do not invent a second Mendoza slug.

    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 foundation as a client site.

    That is the leak: a founder searching “Fundación Scherbovsky clinical trial” or “Scherbovsky Mendoza FIH” finds canonical ALL n=25 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Allende, CORI, or CIPREC. A named foundation is still a site. An NCT location row is not a CRO.

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

    A named foundation 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 foundation 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 foundation 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 Mendoza is not an Allende Córdoba file and is not a CORI La Rioja 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 foundation

    Fundacion Scherbovsky is a serious named Mendoza research foundation on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Allende, CORI, or CIPREC. 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 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 Fundación Scherbovsky directly for a device FIH?

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

    Is this the same page as Sanatorio Allende, CORI, or CIPREC?

    No. Allende is CMS 95645 (Córdoba). CORI is CMS 95672 (La Rioja). CIPREC is CMS 95641. This page is Fundacion Scherbovsky, Mendoza only. First Mendoza slug in the series.

    Is this the first Mendoza intercept?

    Yes. This slug is the Mendoza named-foundation intercept. Do not invent a second Mendoza slug from a spelling variant we did not publish.

    Is this Sanatorio Allende?

    No. Allende is Córdoba (CMS 95645). Mendoza versus Córdoba is the filter.

    Why DEVICE n=0?

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

    Did bioaccess® run NCT02918019?

    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. Córdoba sibling (do not merge): Hospital San Roque Córdoba. Buenos Aires sibling: Hospital Italiano de Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centro de Investigaciones Médicas Mar del Plata: 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 Médicas Mar del Plata as a bioaccess® client.

    If you searched Centro de Investigaciones Medicas Mar del Plata first-in-human, CIM Mar del Plata clinical trial, Mar del Plata CRO Argentina, or “go direct Centro de Investigaciones Médicas Mar del Plata,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Medicas Mar del Plata in Mar del Plata, Argentina, is a real named medical-research-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

    This page is the named Mar del Plata medical-research center. It is not Centro de Investigaciones Médicas Tucumán (CMS 95682), not CIPREC (CMS 95641), and not CINME (CMS 95669). Sharing “investigaciones médicas” in another Argentine city is not a license to collapse them. Instituto de Investigaciones Clínicas Mar del Plata is a different organization (different NCT string family; leftover, not this page). We do not ship a second slug for that leftover.

    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-9-picks-2026-09-02.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. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Centro de Investigaciones Medicas Mar del Plata (Mar del Plata, Argentina) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT01885078, NCT02620046, NCT02760407.
    • Alias Centro de Investigaciones Medicas Mar Del Plata (capital D in Del): ALL n=21. Listed separately. Same slug. We do not invent a unique-study union of 25+21. We do not ship a second slug.
    • Accented alias Centro de Investigaciones Médicas Mar del Plata: ALL n=20. Listed separately. Same slug. No union.

    Cite canonical ALL n=25 and DEVICE n=0. Cite each alias n separately. Do not add 25+21+20. 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 “CIM Mar del Plata clinical trial” or “Centro de Investigaciones Médicas Mar del Plata FIH” finds canonical ALL n=25 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIM Tucumán, CIPREC, CINME, or the leftover Instituto de Investigaciones Clínicas Mar del Plata string. 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:

    • 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 Mar del Plata is not a Tucumán CIM file and is not a Buenos Aires CIPREC or CINME 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 center

    Centro de Investigaciones Medicas Mar del Plata is a serious named research center on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CIM Tucumán, CIPREC, CINME, or Instituto de Investigaciones Clínicas Mar del Plata. 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 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 Médicas Mar del Plata directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as CIM Tucumán, CIPREC, CINME, or Instituto de Investigaciones Clínicas Mar del Plata?

    No. CIM Tucumán is CMS 95682. CIPREC is CMS 95641. CINME is CMS 95669. Instituto de Investigaciones Clínicas Mar del Plata is a different organization and a leftover, not this page. This page is Centro de Investigaciones Medicas Mar del Plata only. Alias ALL n=21 and accented ALL n=20 stay listed separately; we do not union.

    Should I add canonical ALL n=25, alias ALL n=21, and accented ALL n=20?

    No. Alias n is listed separately. A unique-study union is not published. Capital-D “Mar Del Plata” and the accented spelling stay on this slug.

    Is Instituto de Investigaciones Clínicas Mar del Plata this campus?

    No. That is a different organization with a different NCT string. It is leftover, not this page. Sharing Mar del Plata is not a merge.

    Why DEVICE n=0?

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

    Did bioaccess® run NCT01885078?

    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. Argentina siblings (do not merge): CIM Tucumán. Buenos Aires academic sibling: Hospital Italiano de Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • FALP: The NCT Campus String Is Not the ISP File

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

    If you searched FALP first-in-human, Fundacion Arturo Lopez Perez clinical trial, Fundación Arturo López Pérez Santiago CRO, or “go direct FALP,” you followed a campus string ClinicalTrials.gov still publishes. Fundacion Arturo Lopez Perez (FALP) in Santiago, Chile, 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 ISP file.

    bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns ISP, Ethical-Scientific Committee (Law 20.120), investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Santiago FALP campus. Distinct from Hospital Clínico Universidad Católica (CMS 95626), Hospital Clínico Universidad de Chile (CMS 95665), Universidad Andrés Bello (CMS 95657), and Club de Leones Cruz del Sur (CMS 95678). Sharing Santiago or sharing Chile is not a license to collapse them. Punta Arenas is not this campus.

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

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; 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.

    • Fundacion Arturo Lopez Perez (Santiago, Chile) — leftover ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00022516, NCT00045032, NCT00094653.
    • JSONL confirm on the named campus string (1 September 2026 dump): unique NCT IDs n=30. Cite leftover ALL n=25 as ranking. Cite JSONL n=30 as the named string. Same campus. Not two centers.
    • Alias Fundación Arturo López Pérez: ALL n=11. Listed separately. Same slug. No union.
    • Alias FALP: ALL n=7. Listed separately. Same slug. No union.

    Cite leftover ALL n=25 as ranking. Cite JSONL n=30 as the named string. Cite alias n=11 and n=7 separately. Do not add them. DEVICE n=0; we will not pad it. We will not invent PAHO/WHO Level 4 standing for ISP.

    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 “FALP Santiago clinical trial” or “Fundacion Arturo Lopez Perez FIH” finds leftover ALL n=25 (JSONL named-string n=30) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, or Club de Leones. A named Santiago 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:

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

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

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

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

    Do not smear the center

    Fundacion Arturo Lopez Perez is a serious named Santiago cancer center on the public registry. Leftover ALL n=25 is registry volume, not a punchline. JSONL n=30 is the same named string, not a second campus. Do not invent a DEVICE n. Do not invent PAHO/WHO Level 4 for ISP. Do not merge it into Católica, UChile, UNAB, or Club de Leones. 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 ISP / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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 FALP 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 ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this 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 Clínico Universidad Católica, Hospital Clínico Universidad de Chile, Universidad Andrés Bello, or Club de Leones Cruz del Sur?

    No. Católica is CMS 95626. UChile is CMS 95665. UNAB is CMS 95657. Club de Leones is CMS 95678 (Punta Arenas). This page is Fundacion Arturo Lopez Perez / FALP, Santiago only. Leftover ALL n=25 is ranking; JSONL n=30 is the named string; alias n=11 and n=7 stay listed separately. We do not union.

    Should I add leftover ALL n=25, JSONL n=30, alias n=11, and FALP n=7?

    No. Leftover ALL n=25 is the ranking row. JSONL n=30 is the same named string confirmed. Alias n is listed separately. A unique-study union is not published.

    Is FALP a Santiago university hospital?

    No. Católica, UChile, and UNAB remain on their own slugs. This page is Fundacion Arturo Lopez Perez.

    Does ISP have PAHO/WHO Level 4 standing?

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

    Did bioaccess® run NCT00022516?

    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 Chile. Santiago sibling (do not merge): Hospital Clínico Universidad de Chile.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Nacional Cayetano Heredia: The NCT Campus String Is Not the INS 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 INS, 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 Nacional Cayetano Heredia as a bioaccess® client.

    If you searched Hospital Nacional Cayetano Heredia first-in-human, Cayetano Heredia Lima clinical trial, HNCH CRO Peru, or “go direct Hospital Nacional Cayetano Heredia,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Nacional Cayetano Heredia in Lima, Peru, is a real named national-hospital string on ClinicalTrials.gov. It is not Universidad Peruana Cayetano Heredia. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns INS / DIGEMID, accredited 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 named Lima hospital. Distinct from INEN Lima (CMS 95644). It is also not Universidad Peruana Cayetano Heredia (university string ALL n=23 — not this hospital). Sharing “Cayetano Heredia” is not a merge. We do not invent a Peruvian legal entity on this page.

    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 Nacional Cayetano Heredia (Lima, Peru) — leftover ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00352716, NCT00441285, NCT00612898.
    • JSONL confirm on the same named hospital string (1 September 2026 dump): unique NCT IDs n=34. Cite leftover ALL n=25 as the ranking row. Cite JSONL n=34 as the same named hospital string confirmed. Do not treat 25 and 34 as two campuses.
    • Do not merge Universidad Peruana Cayetano Heredia (ALL n=23). That is a university string, not this hospital page. Listed separately so a founder searching the university still does not land here as a union.

    Cite leftover ALL n=25 as ranking. Cite JSONL n=34 as the named hospital string. Do not add them. Do not add the university n=23. 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 hospital as a client site.

    That is the leak: a founder searching “Hospital Nacional Cayetano Heredia clinical trial” or “Cayetano Heredia Lima FIH” finds leftover ALL n=25 (JSONL named-string n=34) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28 — and without landing on INEN. A named Lima hospital is still a site. An NCT location row is not a CRO. We do not invent a Peruvian legal entity.

    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:

    • INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page. We do not invent a Peruvian legal entity. A hallway conversation at Hospital Nacional Cayetano Heredia is not an INEN file and is not a 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 INS actually works (the short version)

    Use clinical-trials-peru. INS (DIIS, formerly OGITT) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new Peruvian clock on this page. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru hub already cites experience-based cost on the order of ~30% lower versus US/EU — that is a country-page figure, not a campus quote we invent here. We do not invent a Peruvian legal entity on this page.

    Ask for a protocol-specific calendar. A hospital email is not INS 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 Nacional Cayetano Heredia is a serious named Lima hospital on the public registry. Leftover ALL n=25 is registry volume, not a punchline. JSONL n=34 is the same named hospital string, not a second campus. Do not merge it into INEN or into Universidad Peruana Cayetano Heredia. Do not invent a DEVICE n. Do not invent a Peruvian legal entity. 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 INS / 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 Nacional Cayetano Heredia 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 INS 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 INEN Lima or Universidad Peruana Cayetano Heredia?

    No. INEN is CMS 95644. Universidad Peruana Cayetano Heredia is a university NCT string (ALL n=23), not this hospital. This page is Hospital Nacional Cayetano Heredia only. Leftover ALL n=25 is ranking; JSONL n=34 is the same named hospital string. We do not union with the university.

    Should I add leftover ALL n=25 and JSONL n=34?

    No. Leftover ALL n=25 is the ranking row. JSONL n=34 is the same named hospital string confirmed. They are not two campuses.

    Is Universidad Peruana Cayetano Heredia this hospital?

    No. That is a university string (ALL n=23). This page is the hospital. We do not merge them. INEN is CMS 95644, a different Lima string.

    Is the 40-business-day figure a device-FIH guarantee?

    No. It is a published statutory target on the Peru hub in the drug-trial framework; 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. Ask for a protocol-specific calendar.

    Did bioaccess® run NCT00352716?

    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 Peru.

    Julio G. Martinez-Clark, CEO · bioaccess®