cms.bioaccessla.com

Category: First-in-Human

  • FLENI Buenos Aires: 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 FLENI Buenos Aires as a bioaccess® client.

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

    bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ANMAT, 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Buenos Aires FLENI campus. It is not Psoriahue, not IDIM, not Centro Medico Arsema (separate page), and not Instituto Privado Kremer Córdoba. Sharing Buenos Aires / Argentina is not a license to collapse them. FLENI is not Psoriahue. FLENI is not IDIM.

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

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

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

    • FLENI (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=52; DEVICE n=1. Example NCT IDs: NCT07475611.

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

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

    That is the leak: a founder searching FLENI Buenos Aires first-in-human finds ALL n=52 (DEVICE n=1) without finding ANMAT. A named institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

    How ANMAT actually works (the short version)

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

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

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

    Not a critique of the hospital

    FLENI is a serious named Buenos Aires campus on the public registry. ALL n=52 and DEVICE n=1 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract FLENI Buenos Aires directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Psoriahue or IDIM Buenos Aires?

    No. Psoriahue has its own page. IDIM has its own page. This page is FLENI only.

    Did bioaccess® run NCT07475611?

    No. We cite it as facility evidence. We will not invent a sponsor or 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. CABA sibling (do not merge): Psoriahue.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto Nacional de Cardiologia Rio de Janeiro: The NCT Campus String Is Not the ANVISA File

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

    If you searched Instituto Nacional de Cardiologia Rio de Janeiro first-in-human, INC Rio clinical trial, INC Brazil CRO, or “go direct Instituto Nacional de Cardiologia Rio de Janeiro,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cardiologia in Rio de Janeiro, Brazil, is a real named cardiology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the named Rio de Janeiro INC campus. It is DISTINCT from Instituto Nacional de Cardiología Ignacio Chávez (Mexico — different country, different regulator). It is not Oncoclínicas Rio de Janeiro (already published). Sharing an Instituto Nacional de Cardiologia name is not a license to collapse Mexico and Brazil. INC Rio is not Ignacio Chávez. INC Rio is not Oncoclínicas.

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

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

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

    • Instituto Nacional de Cardiologia (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=52; DEVICE n=4. Example NCT IDs: NCT04766554, NCT04861805, NCT05572736.

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

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

    That is the leak: a founder searching Instituto Nacional de Cardiologia Rio de Janeiro first-in-human finds ALL n=52 (DEVICE n=4) without finding ANVISA. A named institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Not a critique of the hospital

    Instituto Nacional de Cardiologia Rio de Janeiro is a serious named Brazilian campus on the public registry. ALL n=52 and DEVICE n=4 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Instituto Nacional de Cardiologia Rio de Janeiro directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

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

    No. Instituto Nacional de Cardiología Ignacio Chávez is the Mexico campus. Oncoclínicas Rio de Janeiro is already published. This page is Instituto Nacional de Cardiologia Rio de Janeiro only.

    Did bioaccess® run NCT04766554?

    No. We cite it as facility evidence. We will not invent a sponsor or 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. Distinct Mexico sibling (do not merge): Instituto Nacional de Cardiología Ignacio Chávez.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Unicamp Campinas: The NCT Campus String Is Not the ANVISA File

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

    If you searched Unicamp Campinas first-in-human, Hospital das Clinicas Unicamp clinical trial, Unicamp CRO, or “go direct Unicamp Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Unicamp in Campinas, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the named Campinas Unicamp campus (alias includes Hospital das Clinicas da Unicamp). It is not University of Campinas if already published under a different fold, not Hospital Celso Pierro Campinas (already published), not Loema Instituto Pesquisa Campinas, and not Centro Pesquisa São Lucas Campinas. Sharing Campinas is not a license to collapse them. Unicamp is not Celso Pierro. Unicamp is not Loema.

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

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

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

    • Unicamp (Campinas, Brazil) — canonical NCT string: ALL interventional n=147; DEVICE n=2. Example NCT IDs: NCT04171063, NCT05017636.

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

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

    That is the leak: a founder searching Unicamp Campinas first-in-human finds ALL n=147 (DEVICE n=2) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Not a critique of the hospital

    Unicamp is a serious named Campinas campus on the public registry. ALL n=147 and DEVICE n=2 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Unicamp Campinas directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Hospital Celso Pierro or Loema Campinas?

    No. Hospital Celso Pierro Campinas and Loema Instituto Pesquisa Campinas are already published on their own pages. This page is Unicamp only.

    Did bioaccess® run NCT04171063?

    No. We cite it as facility evidence. We will not invent a sponsor or 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. Campinas sibling (do not merge): Hospital Celso Pierro Campinas.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital de Base 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 Hospital de Base São José do Rio Preto as a bioaccess® client.

    If you searched Hospital de Base Sao Jose do Rio Preto first-in-human, Hospital de Base SJRP clinical trial, Hospital de Base Rio Preto CRO, or “go direct Hospital de Base São José do Rio Preto,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Base in São José do Rio Preto, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

    This page is the named São José do Rio Preto Hospital de Base campus. It is DISTINCT from Hospital de Base do Distrito Federal (Brasília / Distrito Federal — different city, different campus). It is not FAMERP São José do Rio Preto (already published). Sharing a Hospital de Base name is not a license to collapse Brasília and São José do Rio Preto. SJRP Hospital de Base is not Brasília Hospital de Base.

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

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

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

    • Hospital de Base (São José do Rio Preto, Brazil) — canonical NCT string: ALL interventional n=210; DEVICE n=1. Example NCT IDs: NCT04701684.

    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 de Base São José do Rio Preto first-in-human finds ALL n=210 (DEVICE n=1) without finding ANVISA. A named hospital campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

    How ANVISA actually works (the short version)

    Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

    Not a critique of the hospital

    Hospital de Base São José do Rio Preto is a serious named Brazilian campus on the public registry. ALL n=210 and DEVICE n=1 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

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

    Is this the same page as Hospital de Base Distrito Federal Brasília?

    No. Hospital de Base do Distrito Federal is already published for the Brasília campus. This page is Hospital de Base São José do Rio Preto only — different city.

    Did bioaccess® run NCT04701684?

    No. We cite it as facility evidence. We will not invent a sponsor or 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. Distinct Brasília sibling (do not merge): Hospital de Base Distrito Federal Brasília.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Centralized vs decentralized ethics review across Latin American clinical trials

    Not every Latin American country runs clinical-trial ethics the same way. Some markets clear institutional research ethics committees (RECs) in weeks. Others stack a national health-authority desk on top of — or instead of — the hospital committee. Treating “LATAM ethics” as one bottleneck is how a US MedTech startup mis-prices a first-in-human calendar by 60–90 days.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the ethics-architecture cut: institutional versus centralized review, where parallel submission is real, and how that should change country pick for FIH versus feasibility versus pivotal work. Clocks below are already published on country hubs and FIH guides — not new invented medians.

    Two architectures, not one “LATAM IRB”

    Institutional / Type II committee first. A CNBI-registered or nationally accredited hospital or network committee reviews the protocol, consent, and investigator packet. The national authority may run in parallel or after, depending on the statute.

    Centralized / multi-tier. A national ethics or health-research desk is on the critical path before first patient — sometimes after local review, sometimes as the primary gate. Startup time stretches when you serialize desks that the statute allows to run together.

    The myth to retire: every LATAM country waits on the same centralized government bottleneck. The operator question is which desks are parallel and which are serial.

    Country snapshots sponsors actually use

    Panama — parallel MINSA + Type II ethics

    Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) put clinical trials on Type II-accredited committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Ordinary ethics review is capped at 20 business days. High-risk protocols — Class III implants and novel biomaterials — get parallel MINSA + ethics, not a forced serial queue. RESEGIS registration before start; standard projects get a registration receipt in three business days. Practitioner ethics band already on the hub: 3–5 weeks, with MINSA clearance available concurrently on the high-risk track. See Panama Class III FIH and the Decreto 21 explainer.

    Dominican Republic — institutional REC speed on a DIGEMAPS file

    The Dominican Republic is a lead first-in-human jurisdiction for bioaccess®. Local research ethics committee review sits with the site; the national health-authority file (DIGEMAPS / CONABIOS path as published on the CRO in Dominican Republic page) is a separate operating problem. Do not confuse a fast institutional REC letter with a complete national authorization package — and do not invent a CONABIOS median that is not on the live page.

    El Salvador — DNM/SRS as the trial desk

    El Salvador is a published lead FIH geography under DNM/SRS. Trial authorization and ethics sit on that country’s rulebook (Acuerdo 838 BIS and related instruments already cited in our regulatory notes). Use the published 30–60 day trial-authorization band from the FIH cost page — not a new clock here. See Panama / El Salvador FIH cost vs US.

    Colombia — ethics plus INVIMA CTA

    Colombia still has institutional CEI/IRB review and an INVIMA clinical-trial authorization track under the published decree/resolution stack (Decreto 4725/2005; Res. 2378/2008 and related). Commercial INVIMA registro remains a core bioaccess® market-access service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Keep ethics speed and INVIMA CTA risk on separate lines in the budget.

    Brazil — CEP then CONEP / ANVISA for many device paths

    Brazil’s ethics architecture is multi-tier for a large share of interventional research: local CEP review, with CONEP involvement when the study type requires it, plus ANVISA on the regulatory side. That is a serialized or partially overlapping national stack — plan months, not the Panama 3–5 week ethics band. Use ANVISA/CEP guidance already on Brazilian market-access and trial pages; do not paste a Panama clock onto a Brazilian FIH.

    Mexico — COFEPRIS and institutional review

    Mexico pairs institutional ethics with COFEPRIS authorization for many investigational and commercial paths. COFEPRIS vía abreviada and holder/IOR rules are commercial-registration facts (see the Mexico COFEPRIS holder page). For trials, treat COFEPRIS as a national desk on the critical path — not an institutional REC-only country.

    Chile — ISP and institutional ethics

    Chile runs institutional ethics with ISP (Instituto de Salud Pública) on the sanitary/clinical side under the published Código Sanitario / ISP resolution stack. Recent registration waves (including Decreto Exento N° 25 of 2026 on the commercial side) do not erase the trial/ethics split. Use Chile country pages for study-specific clocks; do not invent a national ethics median here.

    Parallel submission: where 60–90 days come from

    The savings appear when you stop serializing desks the statute allows to run together:

    • Panama high-risk: open MINSA and Type II ethics in parallel; register in RESEGIS before start.
    • Import file: start insurance, Spanish IB, and import permit drafting while ethics is open — not after the stamp.
    • Site contracts: do not wait for the national letter to begin CTA negotiation when the site will accept a parallel pack.

    Serialize only when the law requires it (many Brazilian and some Mexican paths). Forcing serial review in a parallel country is a self-inflicted quarter.

    Match architecture to clinical phase

    • FIH / early feasibility (small n). Prefer markets with institutional or parallel Type II review and published short ethics bands — Panama and El Salvador as lead examples on our hubs. Design the file for 21 CFR 812.28 inspectability from day one.
    • Feasibility / expansion cohorts. Add a second country only when enrollment or indication density requires it — keep ethics architectures compatible so monitoring and AE dictionaries stay one system.
    • Pivotal / multi-country. Budget for centralized desks (Brazil, parts of Mexico) and do not price the whole program on a Panama ethics band.

    One-page gate before you pick the country

    1. Which desks are on the critical path? Institutional only, parallel national + ethics, or serialized national.
    2. Is parallel submission written into the statute or decree? Panama Decreto 21 high-risk is yes. Do not assume the same elsewhere.
    3. Spanish packet ready? Protocol, IB, consent, insurance — foreign-language drafts do not substitute.
    4. US filing intended? If yes, ethics speed without 812.28 documentation is a false economy.
    5. Colombia new FIH? Yes: bioaccess® runs first-in-human studies in Colombia now. Commercial registro is a separate conversation.

    If you are choosing between Panama, El Salvador, the Dominican Republic, Chile, or a multi-country plan, send bioaccess® the protocol stage, device risk class, intended US filing, and target first-patient month. We will map the ethics desks — not a brochure “LATAM IRB” average.

    Related: clinical trials, market access, and Australia vs Latin America for FIH.

  • FDA 21 CFR 812.28 in LATAM: foreign clinical trial inspectability for device sponsors

    FDA’s foreign clinical data rule is not a slogan. Under 21 CFR 812.28, the agency can use a well-designed, well-conducted investigation outside the United States to support an IDE or a device marketing application — and it can also show up at the site to validate the file. The question US MedTech teams should ask before first patient in Latin America is not “will FDA accept OUS data?” It is “could an English-speaking inspector reconstruct what happened here?”

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the inspectability cut of 812.28 for LATAM device trials. For the IDE-package framing, use Can OUS first-in-human data support an FDA IDE submission?. For country clocks, use the published Panama and El Salvador hubs — not a new timeline invented here.

    What 812.28 actually requires

    Section 812.28 (final rule, 83 FR 7386, 21 February 2018) says FDA will accept foreign clinical information for an IDE or a device marketing application (PMA, HDE, 510(k), or De Novo) when three conditions are met:

    1. Good clinical practice. Design, conduct, monitoring, auditing, recording, analysis, and reporting that keep data credible and protect subjects — including independent ethics-committee review before initiation, continuing review, and documented freely given informed consent. FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28 (already on our FDA acceptance guide). Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework.
    2. Supporting information in 812.28(b). For a significant-risk device under 812.3(m), submit the full (b) set: investigators and sites; protocol and results; a statement that the investigational device is identical to the US device or a detailed comparison; valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness; IEC identity meeting 812.3(t); consent, monitoring, and investigator GCP training.
    3. Inspectability. FDA can validate the data through an onsite inspection or other appropriate means if the agency deems it necessary. A LATAM file that cannot be inspected is not an 812.28 file.

    Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. Do not plan to live in (e). Build (a).

    The failure mode I see: ethics approval without an inspectable record

    Sponsors who only chase local ethics-committee approval treat the stamp as the finish line. That buys enrollment speed. It does not buy an IDE conversation.

    Three patterns burn the file:

    • Source that cannot be reconstructed. Paper charts in a language and filing system nobody planned to reconcile. When the IDE questions arrive, you cannot show who saw what, when.
    • Device accountability that dies at customs. Investigational units imported through a commercial distributor “because they already import,” with no chain that survives explant, quarantine, and an English-speaking inspector.
    • Consent written in English and “translated later.” 812.28 wants documented consent the IEC actually approved. For FDA use, include the 21 CFR 50.25 elements. Spanish first.

    Those are the same failure modes already named on the OUS-IDE page. Inspectability is the operational layer underneath them.

    What “inspection-ready” means at a LATAM site

    Architect the study so an FDA inspector (or a CRO monitor acting for a later US filing) can walk the site without a scavenger hunt:

    • Electronic data capture with audit trails, not spreadsheet science.
    • Source documents that map to CRF fields in a single reconciliation plan — imaging, device logs, AE narratives.
    • Device accountability from import permit through implant/explant that matches the investigator brochure identity claim in 812.28(b)(5).
    • Monitoring reports that show who visited, what was queried, and what closed — not a one-page “visit done.”
    • Investigator GCP training on file before first procedure, not after the first query.
    • eTMF structure that an English-speaking reviewer can navigate: protocol versions, IEC approvals, consents, safety letters, delegation logs.

    Panama’s Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) already puts high-risk protocols through parallel MINSA + Type II ethics review, RESEGIS registration before start, and 24-hour / 15-day serious-adverse-event clocks. That decree structure helps the local file. It does not replace the 812.28 inspectability design. Same rule for El Salvador under DNM/SRS and for any other lead FIH geography we publish: local authorization is necessary; FDA-usable documentation is a separate design choice.

    Site selection is an inspectability decision

    Pick sites and principal investigators who have already run device protocols with monitors in the room. Early-feasibility n in Panama City is typically 5–20 patients — the right size for a Class III first-in-human cohort (already on the Panama Class III FIH page). Rare disease or a larger n belongs in a multi-country plan.

    Public programs already on the FDA-acceptance guide show the pattern: Axoft FINESSE (first cases at The Panama Clinic; FDA Breakthrough Device Designation in 2022); Newrotex (ethics approval in Panama; FDA Pre-Sub for a 510(k) using LATAM data); ReGelTec HYDRAFIL (Colombia early-feasibility, then FDA IDE for a US pivotal). Those names are already public. I am not adding unpublished sponsors or devices under development.

    Colombia remains a core market-access geography. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Keep commercial registro and investigational CTA tracks apart.

    Pre-Sub before you lock endpoints

    If the LATAM protocol is meant to support a later US IDE, file a Q-Sub / Pre-Sub before you lock endpoints (written feedback in 75 calendar days — already on the FDA-acceptance guide). Endpoints and inclusion criteria have to be relevant to the intended US population; site standard of care has to be comparable to US practice. Changing the device after first implant without a comparability memo makes 812.28(b)(5) unforgiving.

    One-page gate before first patient

    1. US filing intended. IDE, 510(k), De Novo, PMA, or HDE — named before country pick.
    2. Device identity claim. Identical to the US unit, or a written comparison with change control.
    3. IEC + local authority path. Type II / national desk as the country requires — not an ad-hoc hospital chat.
    4. Spanish consent with 21 CFR 50.25 elements if FDA use is the plan.
    5. EDC + eTMF + device accountability that survive an English-speaking inspector.
    6. Monitoring plan with query closure ownership before first implant.

    If you are staring at a LATAM first-in-human calendar and a future FDA conversation, send bioaccess® the protocol stage, device risk class, intended US filing, and whether the investigational unit is identical to the US unit. We will tell you whether the file is being built for 812.28(a) or for a case series.

    Related: FIH without waiting years for FDA, clinical trials, and the LATAM site network.

  • Clinical trial execution in Colombia: why we recommend it now

    Colombia is now in scope for bioaccess® clinical-trial execution across all phases — first-in-human through pivotal — for both medical devices and drugs, in every indication. That is a reversal of our prior position, and the reason is that the regulator changed faster than the market narrative about it did.

    INVIMA is one of eight national authorities certified by PAHO as a Regional Reference Regulatory Authority at Level IV, the highest level PAHO assigns for medicines regulation and surveillance in the Americas (INVIMA, Cooperación internacional; PAHO, Autoridades Regulatorias de Referencia). Since 2022 it has built a dedicated clinical-research group for devices, published its own approval and non-approval registries, and opened a public study search. Sponsors are still pricing Colombia on 2018 assumptions.

    What changed since 2022

    Three institutional facts, all documented by INVIMA itself.

    First, devices got their own clinical-research function: INVIMA created the Grupo de Investigación Clínica y Apoyo a Sala Especializada DMRDIV (GICASE) through Resolución 2022035262 of 20 September 2022 (INVIMA, Investigación Clínica — Dispositivos). Second, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) now has an explicit mandate to evaluate and issue technical and methodological opinions on research protocols involving devices and in vitro diagnostic reagents (INVIMA, Sala especializada DMRDIV). Device sponsors have a named technical body, not an improvised one.

    Third, INVIMA publishes what it approves and what it refuses: a register of device clinical studies approved from 2021 onward, a parallel register of studies not approved with the reason for each — non-approval, withdrawal, pending response — and a register of ethics-committee and research-site inspection status to November 2025 (INVIMA, Investigación Clínica — Dispositivos; register of non-approved device studies). Very few regulators in the region publish their rejections, and that register shows which protocol defects cost applicants a cycle. INVIMA’s public study search lists 1,157 clinical studies, 1,156 of them approved, 487 in progress and 523 completed, with a data date of 12 August 2026 (INVIMA, Lista de Estudios Clínicos).

    The device pathway: prototype authorization through pivotal

    Colombia has no single device clinical-trial regulation. It has three working instruments, and knowing which one carries which obligation is most of the job.

    Decreto 4725 de 2005 is the sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation as one used by a specialist physician in research in an appropriate human clinical setting. Article 36 provides that a national or imported prototype device — or controlled-technology biomedical equipment — may be authorized only for research and experimentation, may not be used in health care, and requires an INVIMA technical opinion. Article 48(b) is the import hook: exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Article 18(k) closes the loop commercially — class IIb and III devices must present clinical studies to demonstrate safety and effectiveness when they later seek Registro Sanitario (Decreto 4725 de 2005).

    Resolución 8430 de 1993 supplies the human-subjects framework — the scientific, technical and administrative rules for health research, including new prophylactic, diagnostic, therapeutic and rehabilitative resources (MinSalud) — and INVIMA names it as the governing instrument for research with human beings.

    The operative paperwork is form-driven and published: ASS-RSA-FM085 (checklist for the prototype-device technical-opinion request), ASS-RSA-FM172 (SEDMRDIV technical-opinion request), ASS-RSA-FM169 (initial study evaluation completed by the ethics committee), ASS-RSA-FM170 (periodic reports) and ASS-RSA-FM171 (serious adverse event notification) (INVIMA, Investigación Clínica — Dispositivos). There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce.

    The drug pathway

    For medicines the anchor is Resolución 2378 de 2008, which adopted Good Clinical Practices with mandatory application for institutions conducting research with medicines in human beings (INS, Resolución 2378 de 2008). INVIMA requires approval for Phase I, II and III protocols and for Phase IV protocols with intervention; non-interventional Phase IV studies must still be submitted with a summary so INVIMA can determine whether formal approval applies (INVIMA, Fiscalización de Ensayos Clínicos).

    Initial protocol evaluation is filed through Protocolos en Línea, the exclusive route for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments; adverse-event content and periodicity are set by Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995 (INVIMA, Fiscalización de Ensayos Clínicos).

    Import of unregistered investigational medicines runs through Article 96 of Decreto 677 de 1995, which lets INVIMA exceptionally authorize importation without sanitary registration where INVIMA or the Ministry has authorized clinical research in the country, following a Comisión Revisora opinion and against a free-sale certificate, corporate documentation and analysis-fee receipts (Decreto 677 de 1995). Where the investigational product is a controlled substance, the monopoly is administered by the Fondo Nacional de Estupefacientes, and INVIMA expressly prioritizes those files in its current contingency plan (Resolución 2025046281 de 2025). Sponsors sometimes look for a separate narcotics department in the trial pathway; the correct counterparty is the FNE, and only for controlled product.

    Timelines, and what the misconception gets wrong

    The complaint about Colombia is that it is slow and unpredictable. Half of that is true.

    Protocol volume has been flat for a decade — roughly 90 protocol-evaluation requests a year, 85 in 2014 and 87 in 2024 — and INVIMA’s average time to a definitive concept, approving or rejecting, is 5.1 months (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable — unpredictability is the charge that does not survive contact with the data.

    Country Published regulatory clock for trial authorization Source
    Colombia No statutory day-count; measured 5.1-month average to a definitive INVIMA concept ConsultorSalud
    Argentina Device studies: Disposición ANMAT 969/1997 Art. 3, up to 90 business days from filing for a decision; clock paused while objections are open Argentina.gob.ar (InfoLEG)
    Chile ISP: 45 business days to authorize import of unregistered pharmaceutical products for trial use ISP Chile
    Panama Decreto Ejecutivo 21 de 2026 regulates Títulos III–IV of Ley 84 de 2019; no day-count published MINSA Panamá

    Two of the four comparators publish no binding clock at all. Colombia’s disadvantage on early-phase device work is smaller than the reputation suggests, and Colombia is the only one of the four that publishes both its approvals and its refusals.

    Sites: Bogotá, Medellín, Cali

    Colombia’s population was estimated at 53 million in 2025 (DANE, July 2025), and by December 2024 more than 160 centres held INVIMA Good Clinical Practice certification (ConsultorSalud).

    INVIMA’s own register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca and Montería, attached to established IPS and medical foundations (INVIMA, CEI list to May 2025). Bogotá, Medellín and Cali are the tier-1 clusters — high-volume tertiary hospitals, certified pharmacy and clinical-laboratory services inside the same certified institution, and investigator populations that read English protocols without translation. Floridablanca (Santander) and Montería extend regional recruitment reach.

    Ethics committees

    A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory and sample-collection services (INVIMA, Certificaciones en BPC). Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

    Post-trial access in Colombia

    Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 were both read in full for post-trial supply language and neither contains it; Resolución 8430 allocates only harm-related costs (Arts. 13, 15(j)–(k), 58(c)). bioaccess® can operate voluntary continuity programs in Colombia on sponsor request. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua — not Colombia.

    What is coming, and why it favours moving now

    Three reform tracks are live. A draft unified sanitary regime would replace Decreto 4725 de 2005 and Decreto 3770 de 2004, adding conditional indefinite authorizations, international reliance mechanisms, mandatory UDI from first filing, four IVD risk classes on IMDRF parameters and an 18-month transition; it cleared national consultation and went to WTO public consultation (ConsultorSalud, June 2026). MinSalud has circulated a draft resolution on health research with human beings that would partially repeal Resolución 8430 de 1993 (ConsultorSalud, February 2026). And a clinical-research framework bill filed in the Cámara in August 2025 by Senator Fabián Díaz Plata and Representative Juan Daniel Peñuela Calvache would adopt ICH E6 and ISO 14155:2020 as the regulatory standard, create an INVIMA registry of authorized CROs and accredited investigators, and impose tacit approval — INVIMA objects within 7 calendar days for common-risk research and 30 for high-risk research, with ratification in a further 5 days (Cámara de Representantes, bill text). It classifies first-in-human studies and novel implantable devices as high-risk.

    None is law yet. All three point the same direction, and each rewards sponsors who already hold Colombian sites, a certified CEI relationship and an INVIMA filing history when a transition period starts.

    Registro Sanitario sits at the far end of the same pathway

    Registro Sanitario is the INVIMA marketing authorization that lets a device be sold in Colombia, granted under Decreto 4725 de 2005 with technical evaluation under Article 18 and legal evaluation under Article 19; INVIMA may issue one request for additional information, with 90 days to respond, and BPM and CCAA certificates run for five years (Decreto 4725 de 2005). bioaccess® already runs Registro Sanitario market access in Colombia, and the reason to place trial and registration with one operator is Article 18(k): the clinical evidence a class IIb or III sponsor generates in Colombia is the evidence its Colombian registration will later be judged on.

    Planning a first-in-human or pivotal trial in Colombia? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region, and Colombia is now in scope for all phases, all indications, devices and drugs. To discuss INVIMA feasibility, site selection in Bogotá, Medellín or Cali, or a combined trial-plus-Registro-Sanitario pathway, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does bioaccess® conduct clinical trials in Colombia?
    Yes. As of September 2026 Colombia is in scope for bioaccess® clinical-trial execution across all phases, from first-in-human through pivotal, in all indications, for both medical devices and drugs. This is a change from our earlier position. The reversal follows documented institutional improvement at INVIMA since 2022 — a dedicated device clinical-research group, a named specialized chamber for device protocols, published approval and non-approval registries, and a public study search — combined with our own operating capability in Bogotá, Medellín and Cali. bioaccess® also runs INVIMA Registro Sanitario market access in Colombia, so the trial and the eventual marketing authorization can be sequenced by one operator.

    What is INVIMA’s role in Colombian clinical trials?
    INVIMA authorizes, monitors and can halt clinical research in Colombia. It evaluates both clinical aspects and the quality of the investigational product, requires approval for Phase I, II and III protocols and for interventional Phase IV protocols, and requires submission of non-interventional Phase IV studies so it can determine whether formal approval applies. It may interrupt an investigation or require modifications at any time if authorization conditions change, Good Clinical Practice is not met, or participant or public-health protection requires it. Sponsor-to-CRO delegations must be reported to INVIMA and remain the sponsor’s responsibility.

    What is the INVIMA clinical-trial pathway for medical devices?
    Three instruments combine. Decreto 4725 de 2005 Article 36 authorizes prototype devices for research and experimentation only, against an INVIMA technical opinion; Article 48(b) permits exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia, following a prior opinion from the specialized chamber; Article 18(k) later requires clinical studies for class IIb and III Registro Sanitario. Resolución 8430 de 1993 supplies the human-subjects rules. The SEDMRDIV issues the technical and methodological opinion, supported since September 2022 by the GICASE group created under Resolución 2022035262.

    What is the INVIMA clinical-trial pathway for drugs?
    Resolución 2378 de 2008 adopted Good Clinical Practices with mandatory application for institutions researching medicines in humans, and is the basis of the site BPC certificate. Initial protocol evaluation is filed through INVIMA’s Protocolos en Línea platform, exclusive for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments. Adverse-event reporting content and periodicity follow Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995. Importation of unregistered investigational medicines runs under Article 96 of Decreto 677 de 1995 with a Comisión Revisora opinion. Controlled substances involve the Fondo Nacional de Estupefacientes, which administers that monopoly.

    What are typical INVIMA authorization timelines in 2026?
    There is no statutory day-count in force for protocol authorization. The measured figure is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year. Sponsors should plan the ethics-committee approval, the INVIMA concept and the import authorization as sequential rather than parallel steps. The clinical-research bill filed in August 2025 would replace the current position with tacit approval — 7 calendar days for common-risk and 30 for high-risk studies — but it is not law.

    Does Colombia require post-trial access?
    No. Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation; Resolución 8430 allocates only harm-related costs. bioaccess® can operate voluntary continuity programs in Colombia on sponsor request, governed by the protocol, the informed consent and the ethics committee’s expectations rather than by statute. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua.

    What is INVIMA Registro Sanitario?
    Registro Sanitario is the INVIMA authorization required to market a medical device in Colombia, granted under Decreto 4725 de 2005 following technical evaluation under Article 18 and legal evaluation under Article 19. INVIMA may issue one request for additional or clarifying information, and the applicant has 90 days to respond before the file is deemed abandoned. Manufacturing and storage certificates — BPM and CCAA — are valid for five years. For class IIb and III devices, Article 18(k) requires clinical studies demonstrating safety and effectiveness, which is why trial design and registration strategy belong in the same plan.

    Which Colombian cities have the best clinical-trial infrastructure?
    Bogotá, Medellín and Cali are the tier-1 clusters, and INVIMA’s own register of approved ethics committees places committees in those three cities plus Floridablanca and Montería, attached to established IPS and medical foundations. More than 160 centres held INVIMA Good Clinical Practice certification as of December 2024. The practical selection criterion is not city size but whether the certified institution holds authorized pharmaceutical service, clinical laboratory and sample-collection services inside the same habilitación, because a contracted service adds documentation to every BPC modification.

    How does Colombia compare to Argentina, Panama and Chile for early-phase device trials?
    On published regulatory clocks, two of the four disclose nothing binding. For device studies, Argentina’s Disposición ANMAT 969/1997 Article 3 gives ANMAT up to 90 business days from filing to decide, with the clock paused while objections are open. Panama’s Decreto Ejecutivo 21 of 23 April 2026 regulates Títulos III and IV of Ley 84 de 2019 with no authorization day-count on the MINSA page. Chile’s ISP publishes 45 business days for the resolution authorizing import of unregistered pharmaceutical products for trial use. Colombia publishes no clock but has a measured 5.1-month average and, unlike the other three, publishes both its approvals and its refusals for device studies.

    What has changed at INVIMA since 2022?
    Resolución 2022035262 of 20 September 2022 created the GICASE group for device clinical research and support to the specialized chamber. The SEDMRDIV now carries an explicit mandate to evaluate device and IVD research protocols. INVIMA publishes registers of approved device studies, non-approved device studies with reasons, SEDMRDIV import authorizations for observational studies, and ethics-committee and site inspection status to November 2025. Its public study search reported 1,157 studies with a data date of 12 August 2026. INVIMA also remains one of eight PAHO Level IV Regional Reference Regulatory Authorities.

    Sources

    • INVIMA — Cooperación internacional (PAHO Level IV ARNr status): https://www.invima.gov.co/el-instituto/cooperacion-internacional
    • PAHO/OPS — Autoridades Regulatorias de Referencia: https://www.paho.org/es/autoridades-regulatorias-referencia
    • INVIMA — Investigación Clínica, Dispositivos (GICASE, Resolución 2022035262 de 2022, forms ASS-RSA-FM085/169/170/171/172, published registers): https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/investigacion-clinica
    • INVIMA — Sala especializada de dispositivos médicos y reactivos de diagnóstico in vitro: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/sala-especializada-dispositivos-reactivos
    • INVIMA — Registro de estudios clínicos con dispositivos médicos no aprobados 2021–2025: https://www.invima.gov.co/biblioteca/registro-estudios-clinicos-dispositivos-medicos-no-aprobados-invima-2021-2025
    • INVIMA — Lista de Estudios Clínicos (public study search, data date 12 August 2026): https://www.invima.gov.co/estudios
    • INVIMA — Fiscalización de Ensayos Clínicos, Medicamentos (Protocolos en Línea, tariffs 4070/4083, Resolución 2011020764 de 2011): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/ensayos-clinicos
    • INVIMA — Procesos de certificación en Buenas Prácticas Clínicas (BPC certificate, 5-year validity): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/licenciamiento-auditorias-y-certificaciones/certificaciones-en-buenas-practicas
    • INVIMA — Listado de Comités de Ética en Investigación aprobados a mayo 2025: https://www.invima.gov.co/biblioteca/comites-etica-investigacion-aprobados-invima-2025
    • Decreto 4725 de 2005 (Arts. 2, 18, 19, 21, 22, 36, 48, 89) — Función Pública, Gestor Normativo: https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697
    • Decreto 677 de 1995 (Art. 96 exceptional import; Arts. 145–146) — INVIMA normograma: https://normograma.invima.gov.co/compilacion/docs/decreto_0677_1995.htm
    • Resolución 2378 de 2008 (Buenas Prácticas Clínicas) — Instituto Nacional de Salud: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Resolución 8430 de 1993 — MinSalud: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Resolución INVIMA 2025046281 de 19 de septiembre de 2025 (contingency plan; Fondo Nacional de Estupefacientes prioritization): http://normograma.invima.gov.co/normograma/compilacion/docs/resolucion_invima_46281_2025.htm
    • Resolución INVIMA 2025010547 de 19 de marzo de 2025 (Plan de Contingencia): https://normograma.invima.gov.co/compilacion/docs/resolucion_invima_10547_2025.htm
    • DANE — Nota Técnica, Proyecciones de Población, July 2025 (53 million in 2025): https://www.dane.gov.co/files/censo2018/proyecciones-de-poblacion/Nacional/NotaTecnica-PPED-jul2025.pdf
    • Cámara de Representantes — clinical-research framework bill, August 2025 (tacit approval 7/30 days, ICH E6, ISO 14155:2020): https://hcrpruebas.camara.gov.co/wp-content/uploads/2025/08/proyectos_ley/25082025_25082025_ver_documento_17.pdf
    • ConsultorSalud, 25 June 2025 — INVIMA average 5.1 months to definitive concept; ~90 protocols/year; 160+ BPC-certified centres: https://consultorsalud.com/colombia-reto-regulacion-estudios-clinicos/
    • ConsultorSalud, June 2026 — draft unified medical device sanitary regime replacing Decretos 4725/2005 and 3770/2004: https://consultorsalud.com/regimen-unico-dispositivos-medicos-impactos/
    • ConsultorSalud, February 2026 — MinSalud draft resolution partially repealing Resolución 8430 de 1993: https://consultorsalud.com/minsalud-investigacion-salud-seres-humanos-ips/
    • Disposición ANMAT 969/1997, Art. 3 — Argentina.gob.ar normativa (InfoLEG): https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-969-1997-42205/texto
    • Instituto de Salud Pública de Chile — 45 business days for trial import authorization: https://www.ispch.gob.cl/pregunta-frecuente/p-141/
    • MINSA Panamá — Decreto Ejecutivo N° 21 de 23 de abril de 2026: https://www.minsa.gob.pa/normatividad/decreto-ejecutivo-ndeg-21-jueves-23-de-abril-2026-que-reglamenta-los-titulos-iii-y-iv
    • bioaccess® — Colombia clinical trial regulatory guide: https://bioaccessla.com/regulatory-guide/colombia

  • FIH cost in Panama or El Salvador vs the US: use published clocks, not invented averages

    Boards ask a cost question that is really a calendar question: how much does a first-in-human medical device trial in Panama or El Salvador cost versus the United States? The honest answer is not a single invoice line. It is which clock you are buying: evidence generation versus domestic site contracting.

    I am Julio Martinez-Clark, CEO of bioaccess®. The figures below are bioaccess® planning bands from our own programs, not a quote. Confirm study-specific budgets with a proposal.

    What “vs the US” usually means

    When founders say the U.S. FIH is “too expensive,” they often mean three stacked costs:

    • Time to first patient — site contracting, IRB sequencing, and treating first implant as a United States-only problem. That is the year described in our FIH-without-waiting-for-FDA article, not the 30-day IDE review clock alone.
    • Per-patient and site economics — LATAM planning bands versus a U.S. academic stack you have not actually bid yet.
    • Evidence quality for later FDA use — ISO 14155 discipline and 21 CFR § 812.28 design, or you bought cheap subjects you cannot spend.

    A Latin America investigation is not a discount coupon on FDA. It is a second evidence calendar that can run while the U.S. path is still being built.

    Panama clocks and bands

    Panama is a lead Class III FIH geography under MINSA and the Comité Nacional de Bioética de la Investigación (CNBI), on Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 — detailed in our Panama Class III FIH guide.

    • Ethics timing: in Panama and Colombia, set by each committee’s meeting schedule.
    • Per-patient band (bioaccess® planning band): about USD 12,000–22,000 per patient in Panama versus about USD 15,000–25,000 in Colombia. These are planning bands, not a tariff.
    • Dollarized economy, English-capable sites, investigation units only — commercial registro stays a separate MINSA market-access file. Do not put a selling license number on FIH freight.

    This page does not quote a “typical U.S. per-patient” dollar figure. If your U.S. sites have not returned a real budget, you do not have a US comparator — you have a hope.

    El Salvador clocks

    El Salvador’s public study-startup language is a 30–60 day band for CNEIS ethics plus SRS clinical-investigation authorization. That band is not a DNM/SRS commercial registro. The sibling post on CNEIS/SRS trial vs DNM registro exists because sponsors keep merging the two clocks and then “comparing cost” against a U.S. IDE that was never the same petition.

    Cost discipline in El Salvador starts with keeping the investigation file off the commercial holder track. Mixing them creates rework that erases any calendar advantage.

    What to put in the board slide (instead of one fake total)

    1. Evidence column. Lead FIH jurisdiction (Panama MINSA/CNBI or El Salvador CNEIS/SRS), ethics desk, investigational importer, § 812.28 owner, ISO 14155 TMF owner.
    2. LATAM planning bands. Use the Panama per-patient and ethics figures above when Panama is in scope. Ask for a study-specific quote before you present a single program total.
    3. U.S. column as real bids. Site budgets, IRB fees, and contracting lead times from named U.S. sites — or leave the cell blank. Blank is more honest than a generic US average.
    4. Commercial column (optional). Holder / IOR countries on the market-access hub. Already-cleared launch is a different SKU from FIH.

    Where “cheap LATAM” burns money

    • Thin TMF. Speed without ISO 14155 monitoring, device accountability, and ethics correspondence buys investor slides and FDA friction.
    • One Gantt bar for FIH and registro. El Salvador’s 30–60 day language is the clearest public warning.
    • Country tourism. Five ethics desks because a slide said “LATAM” dilutes the file.
    • Unbid US baselines. Comparing Panama’s USD 12K–22K planning band to a US number no site has quoted is not diligence.

    Colombia note

    Colombia remains a strong market-access geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Colombia, Panama, El Salvador, Chile, or the Dominican Republic are all options when the protocol needs a lead investigation desk; INVIMA registro stays on its own commercial track.

    Insurance and import are line items, not optional footnotes

    Ethics packets in Panama and El Salvador still want financial responsibility for participant injury documented before initiation — Spanish certificate language is the usual ask. That is a coverage exhibit, not a product-liability rider someone forwarded from a U.S. policy. A master policy that excludes the country fails ethics review, and product liability is not clinical-trial liability. Budget the certificate with the CRO and a licensed broker before you present “LATAM is cheaper.”

    Investigational import is another line that disappears from naive US-vs-LATAM spreadsheets. Name the importer for investigation units. Do not put a cousin commercial registro number on FIH freight — that pattern burns weeks at customs and contaminates both tracks. Our parallel-calendar article covers that failure mode; cost models that ignore it are incomplete.

    How bioaccess® talks about program-level savings

    Across Latin America FIH hubs, bioaccess®’s experience since 2010 is roughly 30% lower program cost and about 40% faster versus typical US baselines. That is an experience-based estimate, not a formal study. Treat that as orientation, not a guarantee for your Class III implant with a thin TMF. Study-specific quotes beat blog averages.

    Practical next step

    This week, rewrite the cost slide as three columns: LATAM evidence calendar, real U.S. site bids (or blank), commercial holder countries if any. Start from the Panama Class III FIH guide or the El Salvador clinical-trials hub for column one. If you need a study-specific number, bring protocol stage, device class, and sample size and bioaccess® will quote the investigation.

  • Reina Madre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    Reina Madre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    Reina Madre in Mexico City, Mexico, is a separate named facility string in the public record.

    General information, not legal or regulatory advice. This page cites a public ClinicalTrials.gov facility row. It does not claim that bioaccess® ran the study, that the facility is a client, or that the registry record is a first-in-human device authorization.

    When a sponsor searches a facility name, the search result can look like a complete clinical-development answer. It is not. A site can contribute investigators, rooms, coordinators, recruitment, and protocol-specific operations. The sponsor still needs the study strategy, contracts, ethics submission, data systems, monitoring, safety reporting, insurance, and the applicable regulatory file. A facility string is not a CRO.

    The public record used here is ClinicalTrials.gov study NCT06581068. The record describes an industry-sponsored study involving IVF-lab automation and lists facilities in Mexico City. The registry is evidence that the facility string appears in a public study record. It is not evidence of a bioaccess® engagement, an endorsement, a completed outcome, or a regulatory clearance.

    What the facility can do

    • Assess whether the protocol fits its patient flow, laboratory capability, staffing, and local research procedures.
    • Discuss investigator interest, site feasibility, visit logistics, and institutional review steps.
    • Provide site-specific costs and operational requirements for the work it will physically perform.

    What the facility row does not establish

    • It does not establish that the facility is the sponsor, CRO, importer of record, insurer, or regulatory applicant.
    • It does not establish the identity or qualifications of a principal investigator beyond whatever the public record itself displays.
    • It does not establish that a treatment-validation study is a first-in-human medical-device study.
    • It does not replace a protocol-specific feasibility review, agreement, or regulatory assessment.

    Mexico City is a site decision, not the whole start-up plan

    For work in Mexico, a sponsor should separate institutional ethics and operational planning from the COFEPRIS pathway. Trial authorization, investigational import, insurance, monitoring, electronic data capture, adverse-event reporting, and the later sanitary registration question are different workstreams. A site email can help answer a local feasibility question. It cannot by itself open the national file or create a quality system.

    bioaccess® can assess the country and protocol fit, coordinate the regulatory and site-start-up work, and keep the operating responsibilities explicit. The correct sequence is to confirm the protocol, identify the required site capabilities, document feasibility, agree the scope, and then activate the facility if it fits. The page is not a claim that either named facility is a signed bioaccess® partner.

    About the registry record

    NCT06581068 is cited here because it is the public source for the facility association. Registry records can change, use facility aliases, and describe a study purpose that is not the same as a sponsor’s later device-regulatory plan. Read the current record directly before making a decision. Do not infer clinical performance, patient outcomes, regulatory status, or commercial availability from a facility name.

    Frequently asked questions

    Did bioaccess® run NCT06581068?

    No. This page cites a public facility row only. We will not invent a client relationship, investigator role, outcome, or sponsor claim.

    Can a sponsor contract the facility directly?

    A sponsor can discuss site interest and local operations with a facility. That discussion is not a substitute for the CRO, regulatory, safety, data, insurance, and multi-country responsibilities the protocol may require.

    Is this a regulatory approval?

    No. A ClinicalTrials.gov listing is not COFEPRIS authorization, ethics approval, import permission, or sanitary registration.

    What is the next step?

    Start with a protocol-specific feasibility and country-fit review. Then define the regulatory, site, monitoring, data, safety, insurance, and import workstreams before activation.

    bioaccess® does not name either facility as a signed partner here. We use the public record to answer a search, not to invent a relationship.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • New Hope Fertility Centre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    New Hope Fertility Centre Mexico City: The NCT Facility String Is Not the COFEPRIS File

    New Hope Fertility Centre in Mexico City, Mexico, is a named facility string in the public record.

    General information, not legal or regulatory advice. This page cites a public ClinicalTrials.gov facility row. It does not claim that bioaccess® ran the study, that the facility is a client, or that the registry record is a first-in-human device authorization.

    When a sponsor searches a facility name, the search result can look like a complete clinical-development answer. It is not. A site can contribute investigators, rooms, coordinators, recruitment, and protocol-specific operations. The sponsor still needs the study strategy, contracts, ethics submission, data systems, monitoring, safety reporting, insurance, and the applicable regulatory file. A facility string is not a CRO.

    The public record used here is ClinicalTrials.gov study NCT06581068. The record describes an industry-sponsored study involving IVF-lab automation and lists facilities in Mexico City. The registry is evidence that the facility string appears in a public study record. It is not evidence of a bioaccess® engagement, an endorsement, a completed outcome, or a regulatory clearance.

    What the facility can do

    • Assess whether the protocol fits its patient flow, laboratory capability, staffing, and local research procedures.
    • Discuss investigator interest, site feasibility, visit logistics, and institutional review steps.
    • Provide site-specific costs and operational requirements for the work it will physically perform.

    What the facility row does not establish

    • It does not establish that the facility is the sponsor, CRO, importer of record, insurer, or regulatory applicant.
    • It does not establish the identity or qualifications of a principal investigator beyond whatever the public record itself displays.
    • It does not establish that a treatment-validation study is a first-in-human medical-device study.
    • It does not replace a protocol-specific feasibility review, agreement, or regulatory assessment.

    Mexico City is a site decision, not the whole start-up plan

    For work in Mexico, a sponsor should separate institutional ethics and operational planning from the COFEPRIS pathway. Trial authorization, investigational import, insurance, monitoring, electronic data capture, adverse-event reporting, and the later sanitary registration question are different workstreams. A site email can help answer a local feasibility question. It cannot by itself open the national file or create a quality system.

    bioaccess® can assess the country and protocol fit, coordinate the regulatory and site-start-up work, and keep the operating responsibilities explicit. The correct sequence is to confirm the protocol, identify the required site capabilities, document feasibility, agree the scope, and then activate the facility if it fits. The page is not a claim that either named facility is a signed bioaccess® partner.

    About the registry record

    NCT06581068 is cited here because it is the public source for the facility association. Registry records can change, use facility aliases, and describe a study purpose that is not the same as a sponsor’s later device-regulatory plan. Read the current record directly before making a decision. Do not infer clinical performance, patient outcomes, regulatory status, or commercial availability from a facility name.

    Frequently asked questions

    Did bioaccess® run NCT06581068?

    No. This page cites a public facility row only. We will not invent a client relationship, investigator role, outcome, or sponsor claim.

    Can a sponsor contract the facility directly?

    A sponsor can discuss site interest and local operations with a facility. That discussion is not a substitute for the CRO, regulatory, safety, data, insurance, and multi-country responsibilities the protocol may require.

    Is this a regulatory approval?

    No. A ClinicalTrials.gov listing is not COFEPRIS authorization, ethics approval, import permission, or sanitary registration.

    What is the next step?

    Start with a protocol-specific feasibility and country-fit review. Then define the regulatory, site, monitoring, data, safety, insurance, and import workstreams before activation.

    bioaccess® does not name either facility as a signed partner here. We use the public record to answer a search, not to invent a relationship.

    Julio G. Martinez-Clark, CEO · bioaccess®