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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.

  • Hospital San Roque 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 San Roque Córdoba as a bioaccess® client.

    If you searched Hospital San Roque Cordoba first-in-human, Hospital San Roque Córdoba clinical trial, San Roque CRO Argentina, or “go direct Hospital San Roque Córdoba,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San Roque in Córdoba, Argentina, is a real named hospital on ClinicalTrials.gov. This page is Córdoba city only. 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 Córdoba-city hospital intercept. Distinct from Sanatorio Allende (CMS 95645) and from Instituto Médico Río Cuarto (this batch — a different city). It is not Centro Medico San Roque Tucumán (a different city and a different NCT string). Sharing “San Roque” in the name is not a license to collapse them.

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

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

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 We do not publish a unique-study union across alias strings.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

    Cite ALL n=27 and DEVICE n=1 as given for the Córdoba-city string. We will not invent extra n for Tucumán.

    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 San Roque Córdoba clinical trial” finds ALL n=27 (DEVICE n=1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Allende, Río Cuarto, or Centro Medico San Roque Tucumán. A named Córdoba 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 San Roque in Córdoba is not an Allende file and is not a Tucumán San Roque 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 San Roque in Córdoba is a serious named hospital on the public registry. ALL n=27 (DEVICE n=1) is registry volume, not a punchline. Do not merge it into Allende, Río Cuarto, or Centro Medico San Roque Tucumán. 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 San Roque 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, Instituto Médico Río Cuarto, or Centro Medico San Roque Tucumán?

    No. Allende is CMS 95645 (a different Córdoba-city campus). Instituto Médico Río Cuarto is a different city on a different slug in this batch. Centro Medico San Roque Tucumán is a different city. This page is Hospital San Roque, Córdoba only.

    Is this Centro Medico San Roque in Tucumán?

    No. That is a different named facility in a different city. This page is Hospital San Roque, Córdoba. Do not collapse the strings because both contain “San Roque.”

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

    No. DEVICE n is unique NCT IDs on the device filter for this facility string. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate.

    Is this the same Córdoba campus as Sanatorio Allende?

    No. Allende is CMS 95645. Sharing Córdoba city is not a merge.

    Did bioaccess® run NCT00330369?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Córdoba sibling (do not merge): Sanatorio Allende.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Neurociencia Durango: 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 Instituto de Neurociencia Durango as a bioaccess® client.

    If you searched Instituto de Investigaciones Aplicadas a la Neurociencia Durango first-in-human, Instituto de Neurociencia Durango clinical trial, Durango CRO Mexico, or “go direct Instituto de Neurociencia Durango,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Investigaciones Aplicadas a la Neurociencia A.C. in Durango, Mexico, is a real named neuroscience-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

    This page is the Durango named neuroscience institute. Distinct from INECO Neurociencias Oroño (CMS 95663 — Rosario, Argentina, ANMAT), UNAM Optometry Clinic (CMS 95658), and INCMNSZ Salvador Zubirán (CMS 95623). Sharing the word “neurociencia” or sharing Mexico is not a license to collapse them. Durango is not Rosario and is not Mexico 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-7-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C. (Durango, Mexico) — canonical NCT string: ALL interventional n=28; DEVICE n=0. Example NCT IDs: NCT01914393, NCT02046369, NCT02165215.

    Cite ALL n=28 as given. We will not invent a DEVICE n. DEVICE n=0 on the picks table; we will not pad it.

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

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

    That is the leak: a founder searching “Instituto de Neurociencia Durango clinical trial” or “Investigaciones Aplicadas a la Neurociencia FIH” finds ALL n=28 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INECO Rosario, UNAM optometry, or INCMNSZ. A named Durango 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:

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

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

    How COFEPRIS actually works (the short version)

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

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

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

    Do not smear the institute

    Instituto de Investigaciones Aplicadas a la Neurociencia A.C. is a serious named Durango institute on the public registry. ALL n=28 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into INECO Rosario, UNAM optometry, or INCMNSZ. 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 Instituto de Neurociencia Durango directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as INECO Rosario, UNAM optometry, or INCMNSZ?

    No. INECO Neurociencias Oroño is CMS 95663 in Rosario, Argentina — a different country and a different regulator (ANMAT). UNAM optometry is CMS 95658. INCMNSZ is CMS 95623 (Mexico City). This page is Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango only.

    Is Durango under a different national agency than Mexico City?

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

    Is this the same “neurociencia” campus as INECO in Rosario?

    No. INECO is Argentina. This institute is Durango, Mexico. Sharing a neuroscience word is not a merge and is not a second slug for INECO.

    Why DEVICE n=0?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=28 is still not COFEPRIS authorization.

    Did bioaccess® run NCT01914393?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CPCLIN: 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 CPCLIN as a bioaccess® client.

    If you searched CPCLIN first-in-human, CPCLIN São Paulo clinical trial, CPCLIN CRO Brazil, or “go direct CPCLIN,” you followed a campus string ClinicalTrials.gov still publishes. CPCLIN in São Paulo, Brazil, is a real named research-clinic string on ClinicalTrials.gov. The named São Paulo research clinic is the site. It is not the CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the named São Paulo research clinic. Distinct from CEPIC (CMS 95662), CPQuali (CMS 95671), Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing a “C” research-clinic prefix is not a license to collapse them.

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

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

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

    • CPCLIN (São Paulo, Brazil) — canonical NCT string: ALL interventional n=28; DEVICE n=0. Example NCT IDs: NCT01885078, NCT02963766, NCT03740919.
    • Expanded legal-name NCT string: ALL n=13. Listed separately. Same slug. We do not invent the expanded corporate legal name on this page. We do not invent a unique-study union of 28+13. We do not ship a second slug for the expanded legal-name string.

    Cite ALL n=28 as given on the canonical string. Cite expanded legal-name NCT string ALL n=13 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 clinic as a client site.

    That is the leak: a founder searching “CPCLIN São Paulo clinical trial” or the expanded legal-name NCT string finds ALL n=28 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina. A named research clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at CPCLIN is not a CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANVISA actually works (the short version)

    Use clinical-trials-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 clinic

    CPCLIN is a serious named São Paulo research clinic on the public registry. ALL n=28 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. Do not invent the expanded legal name. Do not merge it into CEPIC, CPQuali, Einstein, HCor, or Santa Marcelina. Use the site when the protocol fits. Hire the operator.

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

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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 CPCLIN directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

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

    No. CEPIC is CMS 95662. CPQuali is CMS 95671. Einstein, HCor, and Santa Marcelina are separate São Paulo intercepts. This page is CPCLIN only. The expanded legal-name NCT string stays on this slug; we list ALL n=13 separately and do not union.

    What is the expanded legal-name NCT string?

    The picks file records an expanded legal-name NCT string at ALL n=13. We cite that n. We will not invent the exact corporate name if it is not printed as a fact we will stand on. Same slug. No second count as a union.

    Is CPCLIN the same as CEPIC or CPQuali?

    No. CEPIC is Centro Paulista de Investigação Clínica (CMS 95662). CPQuali is CMS 95671. CPCLIN is a different NCT facility string. Sharing São Paulo and sharing a research-clinic prefix is not a merge.

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

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

    Did bioaccess® run NCT03740919 because it also appears on another São Paulo clinic?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. São Paulo sibling (do not merge): CEPIC.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Clinical Research Institute Tlalnepantla: 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 Clinical Research Institute Tlalnepantla as a bioaccess® client.

    If you searched Clinical Research Institute S.C. first-in-human, Clinical Research Institute Tlalnepantla clinical trial, Tlalnepantla CRO Mexico, or “go direct Clinical Research Institute Tlalnepantla,” you followed a campus string ClinicalTrials.gov still publishes. Clinical Research Institute S.C. in Tlalnepantla, Estado de México, Mexico, is a real named research-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

    This page is the Estado de México named clinic. Distinct from Centro de Investigación Clínica de Oaxaca (CMS 95664), FAICIC Veracruz (CMS 95670), INCMNSZ Salvador Zubirán (CMS 95623), INCan (CMS 95655), Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646), Hospital Universitario Dr. José Eleuterio González (CMS 95643), and UNAM Optometry Clinic (CMS 95658). Tlalnepantla is not Mexico City, not Oaxaca, not Veracruz, not Guadalajara, and not Monterrey.

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

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

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

    • Clinical Research Institute S.C. (Tlalnepantla, Mexico) — canonical NCT string: ALL interventional n=28; DEVICE n=0. Example NCT IDs: NCT01793883, NCT02535091, NCT02615184.

    Cite ALL n=28 as given. We will not invent a DEVICE n. DEVICE n=0 on the picks table; we will not pad it.

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

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

    That is the leak: a founder searching “Clinical Research Institute Tlalnepantla clinical trial” or “Clinical Research Institute S.C. FIH” finds ALL n=28 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on Oaxaca, FAICIC, INCMNSZ, INCan, Guadalajara, Eleuterio González, or UNAM optometry. A named Estado de México clinic is still not a CRO.

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

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

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

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

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

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

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

    How COFEPRIS actually works (the short version)

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

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

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

    Do not smear the clinic

    Clinical Research Institute S.C. is a serious named Estado de México research clinic on the public registry. ALL n=28 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Oaxaca, FAICIC, INCMNSZ, INCan, Guadalajara, Eleuterio González, or UNAM optometry. 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 Clinical Research Institute Tlalnepantla 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, INCMNSZ, INCan, Hospital Civil Guadalajara, Eleuterio González, or UNAM optometry?

    No. Oaxaca is CMS 95664. FAICIC is CMS 95670 (Veracruz). INCMNSZ is CMS 95623 (Mexico City). INCan is CMS 95655 (Mexico City). Hospital Civil Guadalajara is CMS 95646. Eleuterio González is CMS 95643 (Monterrey). UNAM optometry is CMS 95658. This page is Clinical Research Institute S.C., Tlalnepantla, Estado de México only.

    Is Tlalnepantla under a different national agency than Mexico City?

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

    Does “Clinical Research Institute” in the name mean this clinic owns COFEPRIS?

    No. A clinic name is not a COFEPRIS authorization. Keep trial clocks separate from registro. An NCT location row is not that file.

    Why DEVICE n=0?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=28 is still not a device-CRO quality system.

    Did bioaccess® run NCT01793883?

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

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centro de Investigaciones Médicas Tucumán: 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 Tucumán as a bioaccess® client.

    If you searched Centro de Investigaciones Medicas Tucuman first-in-human, CIM Tucumán clinical trial, San Miguel de Tucuman CRO, or “go direct Centro de Investigaciones Médicas Tucumán,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Médicas Tucumán in San Miguel de Tucumán, 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 Tucumán medical-research center. Distinct from Centro Médico Privado de Reumatología (CMS 95667). It is also not Centro Medico San Roque Tucumán (a different named string in the same city) and not Hospital San Roque Córdoba (a different city). Sharing Tucumán or sharing “San Roque” in another string is not a license to collapse them.

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

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

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

    • Centro de Investigaciones Medicas Tucuman (San Miguel de Tucumán, Argentina) — canonical NCT string: ALL interventional n=28; DEVICE n=0. Example NCT IDs: NCT03845517, NCT04173273, NCT04376827.
    • City-spelling alias: ALL n=21. Listed separately. Same slug. We do not invent a unique-study union of 28+21. We do not ship a second slug for the city spelling.

    Cite ALL n=28 as given on the canonical string. Cite ALL n=21 on the city-spelling alias. Do not add them. We will not invent a DEVICE n.

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

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

    That is the leak: a founder searching “Centro de Investigaciones Médicas Tucumán clinical trial” or a city-spelling variant finds ALL n=28 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Centro Médico Privado de Reumatología, Centro Medico San Roque Tucumán, or Hospital San Roque Córdoba. A named Tucumán 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 San Miguel de Tucumán is not a rheumatology-clinic file and is not a Córdoba San Roque 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 Médicas Tucumán is a serious named Tucumán research center on the public registry. ALL n=28 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Centro Médico Privado de Reumatología or Centro Medico San Roque Tucumán. 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 Tucumán 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 Centro Médico Privado de Reumatología, Centro Medico San Roque Tucumán, or Hospital San Roque Córdoba?

    No. Centro Médico Privado de Reumatología is CMS 95667. Centro Medico San Roque Tucumán is a different named string in the same city — not this slug. Hospital San Roque Córdoba is a different city and a different slug in this batch. This page is Centro de Investigaciones Médicas Tucumán only. City-spelling alias n stays listed separately; we do not union.

    Should I add ALL n=28 and the city-spelling ALL n=21?

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

    Is this Centro Medico San Roque in Tucumán?

    No. That is a different named facility string. This page is Centro de Investigaciones Médicas Tucumán. Hospital San Roque in Córdoba city is a third building.

    Why DEVICE n=0?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=28 is still not ANMAT authorization.

    Did bioaccess® run NCT03845517?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Tucumán sibling (do not merge): Centro Médico Privado de Reumatología.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Mautalen Salud e Investigación: 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 Mautalen Salud e Investigación as a bioaccess® client.

    If you searched Mautalen Salud e Investigacion first-in-human, Mautalen Buenos Aires clinical trial, Mautalen CRO Argentina, or “go direct Mautalen Salud e Investigación,” you followed a campus string ClinicalTrials.gov still publishes. Mautalen Salud e Investigación in Buenos Aires, Argentina, is a real named clinic 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 clinic is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Buenos Aires clinic intercept. Distinct from Centro Médico Viamonte (CMS 95668), CINME (CMS 95669), CIPREC (CMS 95641), Fundación Respirar (CMS 95653), Hospital Italiano de Buenos Aires (CMS 95620), Hospital Británico de Buenos Aires (CMS 95654), and ENERI / Sagrada Familia (CMS 95625). Sharing Buenos Aires is not a license to collapse them.

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

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

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

    • Mautalen Salud e Investigación (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=29; DEVICE n=0. Example NCT IDs: NCT03519945, NCT04184622, NCT04255433.

    Cite ALL n=29 as given. We will not invent a DEVICE n. DEVICE n=0 on the picks table; we will not pad it.

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

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

    That is the leak: a founder searching “Mautalen Buenos Aires clinical trial” or “Mautalen Salud e Investigación FIH” finds ALL n=29 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Viamonte, CINME, CIPREC, Respirar, HIBA, Británico, or ENERI. A named Buenos Aires clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Mautalen is not a HIBA, Británico, CINME, or CIPREC file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANMAT actually works (the short version)

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

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

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

    Do not smear the clinic

    Mautalen Salud e Investigación is a serious named Buenos Aires clinic on the public registry. ALL n=29 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Viamonte, CINME, CIPREC, Respirar, HIBA, Británico, or ENERI. 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 Mautalen Salud e Investigación directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Viamonte, CINME, CIPREC, Respirar, HIBA, Británico, or ENERI?

    No. Viamonte is CMS 95668. CINME is CMS 95669. CIPREC is CMS 95641. Fundación Respirar is CMS 95653. HIBA is CMS 95620. Británico is CMS 95654. ENERI / Sagrada Familia is CMS 95625. This page is Mautalen Salud e Investigación, Buenos Aires only.

    Why DEVICE n=0 on ALL n=29?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking from a CSV top-40 dump this campus is not on.

    Is Mautalen the same ALL-n=29 campus as Fundación Estudios Clínicos in Rosario?

    No. Sharing an ALL n of 29 is a ranking coincidence. Rosario is a different city and a different NCT string. NCT03519945 can list more than one facility; that is not a merge of the campuses.

    Does “Investigación” in the name mean this clinic owns ANMAT?

    No. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate. A clinic name is not that file.

    Did bioaccess® run NCT04184622?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Buenos Aires sibling (do not merge): Hospital Italiano de Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Fundación Estudios Clínicos: 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 Estudios Clínicos as a bioaccess® client.

    If you searched Fundacion Estudios Clinicos Rosario first-in-human, Instituto Medico de la Fundacion Estudios Clinicos clinical trial, Rosario CRO Argentina, or “go direct Fundación Estudios Clínicos,” you followed a campus string ClinicalTrials.gov still publishes. Fundación Estudios Clínicos in Rosario, Argentina, is a real named clinical-research foundation string on ClinicalTrials.gov. Instituto Medico de la Fundacion Estudios Clinicos is a spelling of the same campus on this slug. 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 Rosario named clinical-research foundation. Distinct from INECO Neurociencias Oroño (CMS 95663), Hospital Provincial del Centenario (CMS 95649), Sanatorio Parque (CMS 95666), and CIPREC (CMS 95641). Sharing Rosario is not a license to collapse them. CIPREC is Buenos Aires, not this foundation.

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

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

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

    • Fundacion Estudios Clinicos (Rosario, Argentina) — canonical NCT string: ALL interventional n=29; DEVICE n=0. Example NCT IDs: NCT03519945, NCT04652518, NCT04987307.
    • Alias on this slug only, no extra n: Instituto Medico de la Fundacion Estudios Clinicos. We list the alias so a founder searching that wording still lands here. We do not invent a second count. We do not publish a unique-study union.

    Cite ALL n=29 as given. We will not invent a DEVICE n for this string. DEVICE n=0 on the picks table; we will not pad it.

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

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

    That is the leak: a founder searching “Fundación Estudios Clínicos Rosario clinical trial” or “Instituto Medico de la Fundacion Estudios Clinicos FIH” finds ALL n=29 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on INECO, Centenario, Sanatorio Parque, or CIPREC. A named Rosario 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 at this Rosario foundation is not an INECO, Centenario, or CIPREC 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

    Fundación Estudios Clínicos is a serious named Rosario research foundation on the public registry. ALL n=29 is registry volume, not a punchline, and not a claim that the foundation is a hospital CRO. Do not invent a DEVICE n. Do not merge it into INECO, Centenario, Sanatorio Parque, or CIPREC. 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 Estudios Clínicos 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 INECO Oroño, Centenario Rosario, Sanatorio Parque, or CIPREC?

    No. INECO is CMS 95663. Centenario is CMS 95649. Sanatorio Parque is CMS 95666. CIPREC is CMS 95641 (Buenos Aires). This page is Fundación Estudios Clínicos, Rosario only. Instituto Medico de la Fundacion Estudios Clinicos is a spelling of this campus, not a second city.

    Is Instituto Medico de la Fundacion Estudios Clinicos a different campus?

    No. It is an alias of Fundacion Estudios Clinicos on this slug. We do not invent extra n. We do not publish a union.

    Why DEVICE n=0?

    That is the picks-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=29 is still not ANMAT authorization.

    Is this the same Rosario campus as INECO or Sanatorio Parque?

    No. INECO Neurociencias Oroño is CMS 95663. Sanatorio Parque is CMS 95666. Centenario is CMS 95649. Sharing Rosario is not a merge.

    Does ALL n=29 mean this foundation already owns ANMAT?

    No. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate. An NCT location row is not that file.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Rosario sibling (do not merge): INECO Neurociencias Oroño.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto Médico Río Cuarto: The NCT Campus String Is Not the ANMAT File

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

    If you searched Instituto Médico Río Cuarto first-in-human, Instituto Medico Rio Cuarto clinical trial, Río Cuarto CRO Argentina, or “go direct Instituto Médico Río Cuarto,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Médico Río Cuarto in Río Cuarto, Argentina, is a real named institute on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

    This page is the Río Cuarto campus intercept. Distinct from Sanatorio Allende (CMS 95645), Hospital Provincial del Centenario (CMS 95649), and Hospital Italiano de La Plata (CMS 95647). It is also not Hospital San Roque Córdoba (this batch — a different city and a different NCT string). Sharing Córdoba province is not a license to collapse them.

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

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

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

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

    Cite ALL n=29 and DEVICE n=1 on the canonical string. Cite ALL n=13 and DEVICE n=3 on the unaccented alias. Do not add them.

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

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

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

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

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

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

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

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

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Río Cuarto is not an Allende or San Roque Córdoba file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANMAT actually works (the short version)

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

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

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

    Do not smear the institute

    Instituto Médico Río Cuarto is a serious named Córdoba-province resource on the public registry. ALL n=29 (DEVICE n=1) is registry volume, not a punchline. Do not merge it into Allende, Centenario, Italiano La Plata, or Hospital San Roque Córdoba. 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 Médico Río Cuarto directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

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

    No. Allende is CMS 95645 (Córdoba city). Centenario is CMS 95649 (Rosario). Italiano La Plata is CMS 95647. Hospital San Roque Córdoba is a separate slug in this batch. This page is Instituto Médico Río Cuarto only. The unaccented NCT spelling stays on this slug; we do not union n.

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

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

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

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

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

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

    Did bioaccess® run NCT04734873?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Córdoba-city sibling (do not merge): Sanatorio Allende.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Club de Leones Cruz del Sur: The NCT Campus String Is Not the ISP File

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

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

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

    This page is the Punta Arenas / Magallanes rehab-hospital intercept. Distinct from Hospital Clínico Universidad de Chile (CMS 95665), Hospital Clínico Universidad Católica (CMS 95626), and Universidad Andrés Bello (CMS 95657). Punta Arenas is not Santiago. A rehab hospital in Magallanes is not Católica, not UChile, and not UNAB. Linking is correct. Collapsing every Chilean campus into Santiago is not.

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

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

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-5-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). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.

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

    Cite ALL n=9 and DEVICE n=8 as given. We will not invent a global CSV rank. We will not invent PAHO/WHO Level 4 standing for ISP. We will not merge this Magallanes campus into Santiago university hospitals.

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

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

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

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

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

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

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

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

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation in Punta Arenas is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ISP actually works (the short version)

    Use clinical-trials-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 hospital

    Club de Leones Cruz del Sur is a serious Magallanes rehab hospital. ALL n=9 (DEVICE n=8) is registry volume, not a punchline. Do not merge it into UChile (CMS 95665), Católica (CMS 95626), or UNAB (CMS 95657). Do not invent PAHO/WHO Level 4 for ISP. Use the site when the protocol fits. Hire the operator.

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

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the ISP / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

    Colombia is still on the map

    A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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 Club de Leones Cruz del Sur directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

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

    No. UChile is CMS 95665 (Santiago). Católica is CMS 95626 (Santiago). UNAB is CMS 95657 (Santiago). This page is Corporación de Rehabilitación Club de Leones Cruz del Sur, Punta Arenas, Magallanes only.

    Is Punta Arenas under a different national agency than Santiago?

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

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

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

    Does ISP have PAHO/WHO Level 4 standing?

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

    Is this a Santiago university hospital?

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Chile.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • UFCSPA: The NCT Campus String Is Not the ANVISA File

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

    If you searched UFCSPA first-in-human, Federal University of Health Sciences of Porto Alegre clinical trial, Universidade Federal de Ciências da Saúde de Porto Alegre CRO, or “go direct UFCSPA,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Health Sciences of Porto Alegre (UFCSPA) in Porto Alegre, Brazil, is a real university string on ClinicalTrials.gov. It is not HCPA. It is not UFRGS-as-HCPA. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the UFCSPA university intercept. Distinct from Hospital de Clínicas de Porto Alegre (CMS 95615). We do not merge UFRGS-as-HCPA. Distinct from Santa Casa Porto Alegre (CMS 95651), Moinhos de Vento (CMS 95622), Hospital Mãe de Deus (this batch), São Lucas PUCRS (CMS 95636), and Fundação Universitaria de Cardiologia (CMS 95612). Sharing Porto Alegre is not a license to collapse them.

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

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

    Counts come from leftover rows in /workspace/five-trials/kill-page-batch-5-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). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.

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

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

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFCSPA is not an HCPA file and is not UFRGS-as-HCPA.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ANVISA actually works (the short version)

    Use clinical-trials-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

    UFCSPA is a serious public health-sciences university. ALL n=21 (DEVICE n=5) on the English string, Portuguese ALL n=17, and short ALL n=6 are registry volume, not a punchline. Do not add the aliases. Do not merge HCPA (CMS 95615), UFRGS-as-HCPA, Santa Casa Porto Alegre, Moinhos, Mãe de Deus, PUCRS, or FUC (CMS 95612). 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 UFCSPA directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

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

    No. HCPA is CMS 95615. UFRGS-as-HCPA is not this campus and is not merged here. Santa Casa Porto Alegre is CMS 95651. Moinhos is CMS 95622. Mãe de Deus is a separate intercept in this batch. São Lucas PUCRS is CMS 95636. FUC is CMS 95612. This page is Federal University of Health Sciences of Porto Alegre / UFCSPA only.

    Why three ALL n values on one page?

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

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

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

    Is this HCPA or UFRGS?

    No. HCPA is CMS 95615. UFRGS-as-HCPA is a different string family and is not merged onto this page. UFCSPA is the Federal University of Health Sciences of Porto Alegre.

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

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

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Porto Alegre sibling (do not merge): HCPA.

    Julio G. Martinez-Clark, CEO · bioaccess®