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Category: Preparing for First-In-Human Studies

Offers insights and best practices for Medtech, Biopharma, and Radiopharma companies preparing for their first-in-human clinical trials.

  • Sanatorio Allende: 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 Sanatorio Allende as a bioaccess® client.

    If you searched Sanatorio Allende first-in-human, Sanatorio Allende Córdoba clinical trial, Allende CRO Argentina, or “go direct Sanatorio Allende,” you followed a campus string ClinicalTrials.gov still publishes. Sanatorio Allende in Córdoba, Argentina, is a real private hospital string on ClinicalTrials.gov. Córdoba is not Buenos Aires and not Pilar. 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 Allende intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), Hospital Universitario Austral (CMS 95638, Pilar), Hospital Italiano de La Plata (this batch), CIPREC (this batch), Sagrada Familia / ENERI (CMS 95625), and Hospital Italiano Asunción (CMS 95517). Interior Argentina is not a Buenos Aires clone.

    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:

    Cite ALL only as given. 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 hospital as a client site.

    That is the leak: a founder searching “Sanatorio Allende clinical trial” or “Córdoba FIH hospital” finds rank 24 on ALL (n=51) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Austral, CIPREC, or La Plata. Córdoba is a different city. Registry volume there is still 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 in Córdoba is not that file. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
    • 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.

    Site versus CRO

    Workstream What Sanatorio Allende (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANMAT clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Córdoba hospital NCT string — not HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.

    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.

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

    Do not smear the hospital

    Sanatorio Allende is a serious Córdoba resource. n=51 ALL is registry volume, not a punchline. Do not merge it into HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción. 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 Sanatorio Allende 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. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción Italiano?

    No. HIBA is CMS 95620 (Buenos Aires). Austral is CMS 95638 (Pilar). ENERI is CMS 95625. Asunción is CMS 95517. CIPREC and Hospital Italiano de La Plata are separate intercepts in this batch. This page is Sanatorio Allende, Córdoba only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is Córdoba under a different national agency than Buenos Aires?

    No. ANMAT is still the national file. The city is different; the trial-versus-registro split is not. Statutory trial-auth target remains on the order of 90 business days and pauses for RFIs. A Córdoba NCT row is not ANMAT clearance.

    Does rank 24 ALL mean this hospital is already the FIH operator?

    No. n is unique NCT IDs on one facility string. It is not ISO 14155 monitoring, not importer of record, and not 21 CFR 812.28. No public bioaccess® case-study page names this hospital.

    Can I treat Allende, HIBA, and Austral as one Argentina MSA?

    No. Three NCT strings. Three cities or campuses. A single-hospital MSA will not stretch. The CRO still owns multi-site optionality, including Colombia.

    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: Hospital Italiano de Buenos Aires. Austral sibling: Hospital Universitario Austral.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • INEN Lima: The NCT Campus String Is Not the INS File

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

    If you searched INEN Lima first-in-human, Instituto Nacional de Enfermedades Neoplasicas clinical trial, INEN CRO Peru, or “go direct INEN Lima,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Enfermedades Neoplasicas (INEN) in Lima, Peru, is a real national cancer-institute string on ClinicalTrials.gov. The ranking dump stores it without an accent: Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. bioaccess® does not operate INEN. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

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

    This page is the Lima INEN intercept. It is not a Brazil, Mexico, or Argentina campus. It does not clone ICESP or Barretos. Sharing an oncology search query is not a license to merge countries. We do not invent a Peruvian legal entity on this page.

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

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

    Cite ALL only as given. 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 hospital as a client site.

    That is the leak: a founder searching “INEN Lima clinical trial” finds rank 23 on ALL (n=51) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28. A national cancer-institute ranking is registry volume, not a CRO, and not a Peruvian entity we invent.

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

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

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

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

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

    • INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page.
    • 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.

    Site versus CRO

    Workstream What INEN (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT INS / DIGEMID clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Lima national cancer-institute NCT string Colombia (INVIMA) and the rest of the bioaccess® platform

    How INS / DIGEMID actually works (the short version)

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

    bioaccess® does not claim to operate INEN and does not invent a Peruvian legal entity on this page. The hospital remains the site. The CRO still owns the file.

    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.

    Ask for a protocol-specific calendar. A hospital email is not INS authorization or a DIGEMID import permit. bioaccess® manages the file. That is CRO work, not site work.

    Do not smear the hospital

    INEN is a serious Lima national institute. n=51 ALL is registry volume, not a punchline. This page is not a claim that bioaccess® operates INEN or that we have a Peruvian legal entity invented for the intercept. Use the site if the protocol fits. Hire the operator. Keep ICESP and Barretos on their Brazil pages.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract INEN Lima directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as ICESP or Barretos Cancer Hospital?

    No. Those are Brazilian NCT strings under ANVISA. This page is Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru, under INS / DIGEMID only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the INS / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is DIGEMID the only agency?

    No. Name both. INS (DIIS, formerly OGITT) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. Do not collapse the stack into “just DIGEMID.” We will not invent DIGESA.

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

    No. It is a published statutory target on the Peru hub in the drug-trial framework; 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new clock. Ask for a protocol-specific calendar.

    Does bioaccess® operate INEN or have a Peruvian entity named here?

    No. We do not claim to operate INEN and do not invent a Peruvian legal entity. The hospital is the site. The ~30% lower versus US/EU figure is already on the Peru hub — not an INEN quote.

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Universitario Dr. José Eleuterio González: The NCT Campus String Is Not the COFEPRIS File

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

    If you searched Hospital Universitario Eleuterio Gonzalez first-in-human, HU UANL Monterrey clinical trial, Jose Eleuterio Gonzalez CRO, or “go direct Hospital Universitario Dr. José Eleuterio González,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario Dr. José Eleuterio González in Monterrey, Mexico, is a real university hospital. ClinicalTrials.gov stores the facility with quotes: Hospital Universitario “Dr. Jose Eleuterio Gonzalez”, Monterrey, Mexico. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

    This page is the Monterrey Eleuterio González intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623, Mexico City) and from CODET Vision Institute Tijuana. Different city. Different NCT string. Do not clone either. Distinct also from Hospital Civil de Guadalajara Fray Antonio Alcalde in this batch.

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

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

    • Hospital Universitario “Dr. Jose Eleuterio Gonzalez” (Monterrey, Mexico): ALL interventional n=52 (rank 21). Example NCT IDs: NCT00543439, NCT01500551, NCT01818752.

    Cite ALL only as given. We will not invent a DEVICE n. Quotes in the NCT string are how the dump stored the campus; they are not a second hospital.

    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 “Eleuterio González clinical trial” or “HU Monterrey FIH” finds rank 21 on ALL (n=52) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ or CODET. Monterrey is not Mexico City and not Tijuana.

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

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

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

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

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

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation in Monterrey is not that file, and it is not an INCMNSZ 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.

    Site versus CRO

    Workstream What Hospital Universitario Dr. José Eleuterio González (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT COFEPRIS clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Monterrey university-hospital NCT string — not INCMNSZ, CODET, or Guadalajara Civil Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

    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.

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

    Do not smear the hospital

    Hospital Universitario Dr. José Eleuterio González is a serious Monterrey academic resource. n=52 ALL is registry volume, not a punchline. Do not merge it into INCMNSZ Mexico City or CODET Tijuana. Do not merge it into Hospital Civil de Guadalajara. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital Universitario Dr. José Eleuterio González directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as INCMNSZ, CODET Tijuana, or Hospital Civil de Guadalajara?

    No. INCMNSZ is CMS 95623 (Mexico City). CODET is the Tijuana ophthalmic intercept. Hospital Civil de Guadalajara Fray Antonio Alcalde is a separate intercept in this batch. This page is the Monterrey quoted NCT string only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the COFEPRIS / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Are the quotes in the NCT name a different campus?

    No. The dump stores Hospital Universitario “Dr. Jose Eleuterio Gonzalez” as one Monterrey facility string. We intercept that spelling. We will not invent a second n from punctuation.

    Is the 2.8-month median a guarantee for this hospital?

    No. Combined start-up 2.8-month median is published on the live Mexico hub, not a campus-only clock we invent. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; registro sanitario ~30 working days is a separate petition. Ask for a protocol-specific calendar.

    Does ranking in Monterrey replace Colombia?

    No. bioaccess® still runs clinical trials in Colombia. A Mexican campus string is not a reason to drop INVIMA optionality. We pick the country the device needs.

    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. INCMNSZ sibling: INCMNSZ Salvador Zubirán.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • ICESP: 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 ICESP as a bioaccess® client.

    If you searched ICESP first-in-human, Instituto do Cancer do Estado de Sao Paulo clinical trial, ICESP CRO, or “go direct ICESP,” you followed a campus string ClinicalTrials.gov still publishes. Instituto do Cancer do Estado de Sao Paulo – ICESP in São Paulo is a real cancer-institute string on ClinicalTrials.gov. bioaccess® does not operate that institute. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page answers the NCT string Instituto do Cancer do Estado de Sao Paulo – ICESP only. Distinct from University of Sao Paulo (CMS 95616), Hospital das Clínicas FMUSP (CMS 95630), and InCor HCFMUSP (CMS 95522). The cancer institute string is not the general HC campus and not the university string. Do not copy heart-institute device claims here. Distinct also from FAMERP and Barretos in this batch.

    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:

    • Instituto do Cancer do Estado de Sao Paulo – ICESP (São Paulo, Brazil): ALL interventional n=54 (rank 19). Example NCT IDs: NCT00567190, NCT00950300, NCT01120184.

    Cite ALL only as given. We will not invent a DEVICE n for this string.

    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 “ICESP clinical trial” finds a cancer-institute campus (ALL n=54, rank 19) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on USP, HCFMUSP, or InCor. A cancer-institute ranking is registry volume, not a CRO, and not a merged HC campus.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023. A hallway conversation at ICESP is not that dossier, and it is not a USP, HCFMUSP, or InCor 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.

    Site versus CRO

    Workstream What ICESP (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One ICESP cancer-institute NCT string — not USP, HCFMUSP, or InCor Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

    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.

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

    Do not smear the hospital

    ICESP is a serious São Paulo cancer institute. n=54 ALL is registry volume, not a punchline. Do not merge it into the university string, the general Hospital das Clínicas FMUSP campus, or InCor. Do not smear Barretos or FAMERP by collapsing every Brazilian cancer campus. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as USP (95616), HCFMUSP (95630), or InCor (95522)?

    No. CMS 95616 is University of Sao Paulo. CMS 95630 is Hospital das Clínicas FMUSP. CMS 95522 is InCor. This page is Instituto do Cancer do Estado de Sao Paulo – ICESP only. We will not invent InCor or USP studies here.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is ICESP the same as Hospital das Clínicas FMUSP?

    No. The cancer-institute string is not the general HC campus. HCFMUSP is CMS 95630. Sharing a city is not a license to clone that intercept or to copy its DEVICE n here.

    Is this Barretos Cancer Hospital?

    No. Barretos is a different city and a different NCT string (DEVICE n=7, rank 21, no ALL row). This page is ICESP in São Paulo.

    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. Siblings: University of Sao Paulo, HCFMUSP, InCor. Country: clinical trials in Brazil.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • CIPREC: 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 CIPREC as a bioaccess® client.

    If you searched CIPREC first-in-human, CIPREC Buenos Aires clinical trial, CIPREC CRO Argentina, or “go direct CIPREC,” you followed a campus string ClinicalTrials.gov still publishes. The NCT facility string is CIPREC, Buenos Aires, Argentina. We name only that registry string. We will not invent an expansion of the CIPREC acronym. 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 CIPREC Buenos Aires intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), Sagrada Familia / ENERI (CMS 95625), Hospital Universitario Austral (CMS 95638), Hospital Italiano de La Plata (this batch), and Hospital Italiano Asunción (CMS 95517). Linking is correct. Collapsing Buenos Aires, Pilar, La Plata, and Asunción because they share a language 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:

    Cite ALL only as given. We will not invent a DEVICE n or an acronym expansion.

    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 “CIPREC clinical trial” finds rank 16 on ALL (n=55) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Austral, ENERI, or La Plata. High ALL volume on a short facility string is still not a CRO, and not a client we invent.

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

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

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

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

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

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in Buenos Aires is not that file. Trial authorization and commercial registro remain separate petitions.
    • 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.

    Site versus CRO

    Workstream What CIPREC (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANMAT clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One CIPREC Buenos Aires NCT string — not HIBA, Austral, ENERI, La Plata, or Asunción Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.

    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.

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

    Do not smear the hospital

    CIPREC is a real Buenos Aires facility string with n=55 ALL. That volume is not a punchline. We will not smear it by inventing an acronym, a PI, or a client claim. Do not merge it into HIBA, Austral, ENERI, La Plata, or Asunción. 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 CIPREC 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. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as HIBA, Austral, ENERI, La Plata, or Hospital Italiano Asunción?

    No. HIBA is CMS 95620. Austral is CMS 95638. Sagrada Familia / ENERI is CMS 95625. Asunción Italiano is CMS 95517 (DINAVISA, Paraguay). Hospital Italiano de La Plata is a separate intercept in this batch. This page is the NCT string CIPREC, Buenos Aires, Argentina only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    What does CIPREC stand for?

    We will not invent an expansion. The public ranking dump stores the facility as CIPREC, Buenos Aires, Argentina. That is the string this page intercepts.

    Is the 90-business-day figure a guarantee of start-up?

    No. It is a published statutory target on the trial-authorization side and the clock pauses for RFIs. Trial versus registro are separate. Ask for a protocol-specific calendar. An NCT row is not ANMAT clearance. Same Argentina hub used on the HIBA intercept (CMS 95620).

    NCT00094302 also appears on another campus. Does that merge the hospitals?

    No. Example IDs are facility evidence from the dump. Shared NCT IDs across location rows do not make CIPREC the same building as Hospital Italiano de La Plata or HIBA. We still will not invent a PI.

    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: Hospital Italiano de Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Nossa Senhora da Conceição: The NCT Campus String Is Not the ANVISA File

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

    If you searched Hospital Nossa Senhora da Conceicao first-in-human, Conceição Porto Alegre clinical trial, HNSC CRO Brazil, or “go direct Hospital Nossa Senhora da Conceição,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Nossa Senhora da Conceição in Porto Alegre is a real hospital. ClinicalTrials.gov stores the facility string as Hospital Nossa Senhora da Conceicao (unaccented). It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the Conceição campus intercept. Distinct from Hospital de Clínicas de Porto Alegre (CMS 95615), Fundação Universitaria de Cardiologia (CMS 95612), Hospital Moinhos de Vento (CMS 95622), and Hospital São Lucas da PUCRS (CMS 95636). Four (plus) Porto Alegre buildings. Four (plus) queries. We do not merge Hospital das Clinicas – UFRGS or any UFRGS string into this page or into HCPA. UFRGS is skipped entirely.

    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:

    Cite ALL only as given. We will not invent a DEVICE n. We will not borrow UFRGS n=53 onto this campus.

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

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

    That is the leak: a founder searching “Conceição Porto Alegre clinical trial” finds rank 13 on ALL (n=58) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, FUC, Moinhos, or São Lucas. Porto Alegre has multiple hospitals. An NCT city field is not a license to collapse them, and it is not a license to paste UFRGS onto Conceição.

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

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

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

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

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

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

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

    Site versus CRO

    Workstream What Hospital Nossa Senhora da Conceição (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Conceicao Porto Alegre NCT string — not HCPA, FUC, Moinhos, São Lucas, or UFRGS Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

    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.

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

    Do not smear the hospital

    Hospital Nossa Senhora da Conceição is a serious Porto Alegre resource. n=58 ALL is registry volume, not a punchline. Do not merge it into HCPA, FUC, Moinhos, or São Lucas. Do not merge UFRGS / Hospital das Clinicas – UFRGS here. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital Nossa Senhora da Conceição directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as HCPA, FUC, Moinhos, São Lucas, or UFRGS?

    No. HCPA is CMS 95615. FUC is CMS 95612. Moinhos is CMS 95622. São Lucas PUCRS is CMS 95636. UFRGS is not an intercept on this page and is not merged into HCPA. This page is Hospital Nossa Senhora da Conceicao only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is this the same hospital as Hospital de Clínicas de Porto Alegre?

    No. HCPA is CMS 95615. Conceição is a different NCT string. Sharing Porto Alegre does not make them one ANVISA file.

    Why skip UFRGS on this page?

    Hospital das Clinicas – UFRGS is a different facility string. Merging it here would clone HCPA. We skip UFRGS entirely rather than invent a third Porto Alegre intercept from that dump row.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Porto Alegre siblings: HCPA, FUC, Moinhos de Vento, São Lucas PUCRS. Country: clinical trials in Brazil.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • FAMERP São José do Rio Preto: 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 FAMERP São José do Rio Preto as a bioaccess® client.

    If you searched FAMERP first-in-human, Fundação Faculdade Regional de Medicina de São José do Rio Preto clinical trial, FAMERP CRO Brazil, or “go direct FAMERP São José do Rio Preto,” you followed a campus string ClinicalTrials.gov still publishes. Fundação Faculdade Regional de Medicina de São José do Rio Preto (FAMERP) in São José do Rio Preto, Brazil, is a real campus string on ClinicalTrials.gov. It is not a São Paulo capital hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the São José do Rio Preto FAMERP intercept. Distinct from University of Sao Paulo (CMS 95616), Hospital das Clínicas FMUSP (CMS 95630), ICESP (this batch), UNIFESP (CMS 95632), and Barretos Cancer Hospital (this batch). Different cities or different NCT strings. Do not collapse interior São Paulo state into the capital because both appear on a LATAM ranking.

    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:

    • Fundação Faculdade Regional de Medicina de São José do Rio Preto (São José do Rio Preto, Brazil): ALL interventional n=61 (rank 11). Example NCT IDs: NCT01972568, NCT01997229, NCT02145611.

    Cite ALL only as given for this string. We will not invent a DEVICE n that the dump did not publish for this row.

    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 “FAMERP clinical trial” or “São José do Rio Preto FIH” finds rank 11 on the ALL list (n=61) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on USP, HCFMUSP, ICESP, UNIFESP, or Barretos. Registry volume in the interior is still not a CRO product, and not a claim that bioaccess® ran any of those IDs.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in São José do Rio Preto is not that dossier, and it is not a USP or ICESP 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.

    Site versus CRO

    Workstream What FAMERP (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One São José do Rio Preto campus string — not USP, HCFMUSP, ICESP, UNIFESP, or Barretos Colombia (INVIMA) and the rest of the bioaccess® platform

    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.

    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.

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

    Do not smear the hospital

    FAMERP is a serious academic resource in São José do Rio Preto. Rank 11 on ALL (n=61) is registry volume, not a punchline. Do not merge it into USP, HCFMUSP, ICESP, UNIFESP, or Barretos. 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 FAMERP São José do Rio Preto directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as USP, HCFMUSP, ICESP, UNIFESP, or Barretos?

    No. USP is CMS 95616. HCFMUSP is CMS 95630. UNIFESP is CMS 95632. ICESP and Barretos are separate intercepts in this batch. This page is Fundação Faculdade Regional de Medicina de São José do Rio Preto / FAMERP only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is São José do Rio Preto the same metro as ICESP or HCFMUSP?

    No. ICESP and Hospital das Clínicas FMUSP sit on São Paulo capital strings. FAMERP is a São José do Rio Preto string. City fields on ClinicalTrials.gov are not a license to merge campuses.

    Does rank 11 ALL mean this campus is already a device FIH operator?

    No. Rank is unique NCT IDs on one facility string. Combined ethics + ANVISA still typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. An ALL ranking does not write that 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. Capital siblings: University of Sao Paulo, HCFMUSP.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Universitario Austral: 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 Universitario Austral as a bioaccess® client.

    If you searched Hospital Universitario Austral first-in-human, Austral Pilar clinical trial, HUA CRO Argentina, or “go direct Hospital Universitario Austral,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario Austral in Pilar, Argentina, is a real university hospital. 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 Pilar campus intercept. It does not clone Hospital Italiano de Buenos Aires (CMS 95620), Sagrada Familia / ENERI (CMS 95625), or Hospital Italiano Asunción (CMS 95517). Different cities. Different NCT strings. Asunción is a different country and a different regulator (DINAVISA).

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

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

    • Hospital Universitario Austral (Pilar, Argentina): ALL interventional n=52 (rank 22). Sponsor class: INDUSTRY:49; OTHER:3. Example NCT IDs: NCT00057720, NCT00411385, NCT00443118.

    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 Universitario Austral clinical trial” or “Austral Pilar FIH” finds rank 22 on ALL (n=52) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA or Asunción Italiano, which are different files.

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

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

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

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

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

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

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

    Site versus CRO

    Workstream What Hospital Universitario Austral (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANMAT clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Pilar campus string — not HIBA, not ENERI, not Asunción Italiano Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANMAT actually works (the short version)

    Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.

    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.

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

    Do not smear the hospital

    Hospital Universitario Austral is a serious Pilar academic resource. n=52 ALL is registry volume, not a punchline. Do not merge it into Hospital Italiano de Buenos Aires or into Asunción. Trial authorization and registro remain separate ANMAT petitions.

    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 Universitario Austral 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. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as Hospital Italiano de Buenos Aires, ENERI, or Hospital Italiano Asunción?

    No. HIBA is CMS 95620. Sagrada Familia / ENERI is CMS 95625. Asunción Italiano is CMS 95517 (DINAVISA, Paraguay). This page is Hospital Universitario Austral in Pilar only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is the 90-business-day figure a guarantee of start-up?

    No. It is a published statutory target on the trial-authorization side and the clock pauses for RFIs. Trial versus registro are separate. Ask for a protocol-specific calendar. An NCT row is not ANMAT clearance.

    Does INDUSTRY:49 mean bioaccess® ran those studies?

    No. That is the ALL-row sponsor-class split. No public bioaccess® case-study page names this hospital. We will not invent a PI or a client claim.

    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: Hospital Italiano de Buenos Aires.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Faculdade de Medicina do ABC: 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 Faculdade de Medicina do ABC as a bioaccess® client.

    If you searched Faculdade de Medicina do ABC first-in-human, FMABC clinical trial, Medicina do ABC Santo André CRO, or “go direct Faculdade de Medicina do ABC,” you followed a campus string ClinicalTrials.gov still publishes. Faculdade de Medicina do ABC in Santo André, São Paulo state, is a real medical school / campus string on ClinicalTrials.gov. Santo André is a different city from São Paulo proper. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the Santo André FMABC intercept. It is not USP, not UNIFESP, and not UNINOVE. Different cities or different NCT strings. Do not collapse ABC into a São Paulo university because the metro area is large.

    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:

    • Faculdade de Medicina do ABC (Santo André, Brazil): ALL interventional n=67 (rank 8). Sponsor class: INDUSTRY:59; OTHER:8. Example NCT IDs: NCT00036647, NCT00337103, NCT00582426.

    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 “Faculdade de Medicina do ABC clinical trial” or “FMABC FIH” finds rank 8 on the ALL list (n=67) without finding ANVISA, import, insurance, or 21 CFR 812.28. INDUSTRY:59 is registry sponsor class, not a bioaccess® client list. We cite ALL only as given for this string.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023. A hallway conversation in Santo André is not that dossier, and it is not a USP or UNIFESP 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.

    Site versus CRO

    Workstream What FMABC (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Santo André campus string — not USP, UNIFESP, or UNINOVE Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANVISA and CEP actually work (the short version)

    Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

    • Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
    • Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
    • Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
    • For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
    • Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
    • Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

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

    Do not smear the hospital

    Faculdade de Medicina do ABC is a serious academic resource in Santo André. Rank 8 on ALL (n=67) is registry volume, not a punchline. High industry share is still not a device-CRO quality system. Do not merge ABC into USP, UNIFESP, or UNINOVE.

    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 Faculdade de Medicina do ABC directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as USP, UNIFESP, or UNINOVE?

    No. USP is CMS 95616 (São Paulo). UNIFESP is a separate intercept in this batch. UNINOVE is CMS 95619. This page is Faculdade de Medicina do ABC in Santo André only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Is Santo André the same city as the USP campus?

    No. The ranking prints city Santo André for this string. University of Sao Paulo and UNIFESP print São Paulo. Different city field. Different NCT string. Do not merge them.

    Does rank 8 ALL mean this is the top Brazilian device site?

    No. This citation is ALL interventional. We are not inventing a DEVICE n that the dump did not give us for this string. Ranking is not a bioaccess® study claim.

    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. Sibling São Paulo NCT string: University of Sao Paulo.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital São Lucas da PUCRS: The NCT Campus String Is Not the ANVISA File

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

    If you searched Hospital Sao Lucas PUCRS first-in-human, Hospital São Lucas da PUCRS clinical trial, São Lucas Porto Alegre CRO, or “go direct Hospital São Lucas da PUCRS,” you followed a campus string ClinicalTrials.gov still publishes. Hospital São Lucas da PUCRS in Porto Alegre is a real university hospital. ClinicalTrials.gov stores more than one spelling. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is one intercept for two ALL spellings of the same campus. It does not clone Hospital de Clínicas de Porto Alegre (CMS 95615), Fundação Universitaria de Cardiologia (CMS 95612), or Hospital Moinhos de Vento (CMS 95622). Three (plus) Porto Alegre buildings. Three (plus) queries. List both strings; do not add the n’s as unique studies.

    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:

    Two strings. Two ranks. Do not publish n=112 as if they were unique studies.

    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 “São Lucas PUCRS clinical trial” finds two ALL spellings of one Porto Alegre campus without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, FUC, or Moinhos.

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

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

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

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

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

    • ANVISA. Device investigations sit under RDC 837/2023. A hallway conversation at São Lucas is not that dossier, and it is not an HCPA 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.

    Site versus CRO

    Workstream What São Lucas PUCRS (site) typically owns What the CRO still owns
    Procedure Rooms, caseload, local staff, source documents Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle
    National authority Not the permit holder by appearing on an NCT ANVISA clinical-investigation file
    Import Receiving and storage if contracted Importer of record
    Quality Hospital or university quality and the case ISO 14155 monitoring, EDC, SAE, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality Two NCT spellings of one Porto Alegre campus; not HCPA, FUC, or Moinhos Colombia (INVIMA) and the rest of the bioaccess® platform

    How ANVISA and CEP actually work (the short version)

    Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this campus needs on one screen, already published there and not re-averaged here:

    • Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
    • Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
    • Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
    • For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
    • Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
    • Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

    Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

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

    Do not smear the hospital

    Hospital São Lucas da PUCRS is a serious academic resource. n=56 on each spelling is registry volume, not a punchline and not a unique-n total of 112. Do not merge Porto Alegre buildings. Use the site when the protocol fits. Hire the operator.

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

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

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

    Colombia is still on the map

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

    Frequently asked questions

    Can I contract Hospital São Lucas da PUCRS directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

    Is this the same page as HCPA, FUC, or Moinhos de Vento?

    No. HCPA is CMS 95615. FUC is CMS 95612. Moinhos is CMS 95622. This page is Hospital São Lucas da PUCRS / Hospital Sao Lucas – PUCRS only.

    If I already have this campus, what does the CRO still do?

    Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

    Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

    No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

    Why merge two names onto one page?

    Because they are accent and punctuation aliases of one campus. ClinicalTrials.gov counted them separately (rank 14 and rank 15, both n=56). Sponsors search both. One slug. We do not add the n’s.

    Is this the same as Hospital de Clínicas de Porto Alegre?

    No. HCPA is a different university hospital already intercepted. Porto Alegre has multiple buildings. An NCT city field is not a license to collapse them.

    Next step

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

    Julio G. Martinez-Clark, CEO · bioaccess®