cms.bioaccessla.com

Blog

  • Centro Paulista de Oncologia São Paulo: The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Centro Paulista de Oncologia São Paulo as a bioaccess® client.

    If you searched Centro Paulista de Oncologia Sao Paulo first-in-human, Centro Paulista de Oncologia clinical trial, CPO Sao Paulo device study, or “go direct Centro Paulista de Oncologia São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Centro Paulista de Oncologia in São Paulo, Brazil, is a real named clinic-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 812.28) package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named São Paulo Centro Paulista de Oncologia campus. It is DISTINCT from Beneficência Portuguesa de São Paulo, Oncoclínicas Rio de Janeiro, Núcleo de Oncologia da Bahia Salvador, and other oncology strings. Sharing São Paulo or Oncologia is not a license to collapse them.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in São Paulo, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Centro Paulista de Oncologia (São Paulo, Brazil) — registry strings counted: “Centro Paulista de Oncologia”. ALL studies n=9; interventional n=4; DEVICE n=1. Example NCT IDs: NCT01478269, NCT03151629, NCT03942497.

    Counted once per NCT ID for São Paulo locations; 5 of the 9 are observational.

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

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

    That is the leak: a founder searching Centro Paulista de Oncologia in São Paulo finds ALL n=9 (DEVICE n=1) without finding ANVISA. A named clinic 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 clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

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

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

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

    • ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Centro Paulista de Oncologia is not a Beneficência Portuguesa file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the clinic

    Centro Paulista de Oncologia is a serious named São Paulo campus on the public registry. ALL n=9 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Centro Paulista de Oncologia São Paulo directly for a device FIH?

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

    Did bioaccess® run the NCT IDs listed here?

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

    Is this the same page as Beneficência Portuguesa de São Paulo?

    No. Beneficência Portuguesa is a distinct São Paulo campus string. This page is Centro Paulista de Oncologia only.

    Did bioaccess® run NCT01478269?

    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. São Paulo sibling (do not merge): Laboratory of Phototherapy São Paulo.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Federal University of Juiz de Fora (UFJF): The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Federal University of Juiz de Fora (UFJF) as a bioaccess® client.

    If you searched Federal University of Juiz de Fora first-in-human, Universidade Federal de Juiz de Fora clinical trial, UFJF device study, or “go direct Federal University of Juiz de Fora (UFJF),” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Juiz de Fora (Universidade Federal de Juiz de Fora, UFJF) in Juiz de Fora, Brazil, is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for UFJF exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ANVISA file.

    bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ANVISA, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 campus still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named UFJF university string. It is DISTINCT from CMiP Juiz de Fora, a separately named clinic campus in the same city. Sharing Juiz de Fora is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Juiz de Fora, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Federal University of Juiz de Fora (Juiz de Fora, Brazil) — registry strings counted: “Federal University of Juiz de Fora”; “Universidade Federal de Juiz de Fora”; “federal University of Juiz de Fora”. ALL studies n=10; interventional n=10; DEVICE n=1. Example NCT IDs: NCT00545103, NCT00943475, NCT01544439.

    Aliases (Federal University of Juiz de Fora; Universidade Federal de Juiz de Fora) are counted once per NCT ID for Juiz de Fora locations.

    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 campus as a client site.

    That is the leak: a founder searching Federal University of Juiz de Fora finds ALL n=10 (DEVICE n=1) 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 campus 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 campus 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 campus is not built to own for an investigational device:

    • ANVISA. Device investigations sit under ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFJF is not a CMiP file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the university

    Federal University of Juiz de Fora is a serious named Brazilian university campus on the public registry. ALL n=10 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Federal University of Juiz de Fora (UFJF) directly for a device FIH?

    You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurance coordinator, 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 campus. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as CMiP Juiz de Fora?

    No. CMiP Juiz de Fora is a distinct clinic campus already published. This page is the UFJF university string only.

    Did bioaccess® run NCT00545103?

    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. Juiz de Fora sibling (do not merge): CMiP Juiz de Fora.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Churruca (Churruca-Visca) Buenos Aires: The NCT Campus String Is Not the ANMAT File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Argentina’s National Administration of Drugs, Foods and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital Churruca Buenos Aires as a bioaccess® client.

    If you searched Hospital Churruca Visca Buenos Aires first-in-human, Hospital Churruca clinical trial, Churruca-Visca device study, or “go direct Hospital Churruca Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Churruca in Buenos Aires, Argentina (also registered as Hospital Churruca Visca and Hospital Churruca-Visca), is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (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, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Buenos Aires Hospital Churruca / Churruca-Visca campus. It is DISTINCT from Hospital General de Agudos Dr. Cosme Argerich, Hospital Italiano de Buenos Aires, and other Buenos Aires campuses already published. Sharing Buenos Aires is not a license to collapse them.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Buenos Aires, Argentina. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Churruca (Buenos Aires, Argentina) — registry strings counted: “Hospital Churruca”; “Hospital Churruca – Visca”; “Hospital Churruca Visca”; “Hospital Churruca-Visca”. ALL studies n=10; interventional n=9; DEVICE n=1. Example NCT IDs: NCT00026338, NCT00036647, NCT00040183.

    Aliases are counted once per NCT ID for Buenos Aires locations; 1 of the 10 are observational.

    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 Churruca in Buenos Aires finds ALL n=10 (DEVICE n=1) without finding ANMAT. 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:

    • ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Hospital Churruca is not an Argerich file and is not an ANMAT 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the hospital

    Hospital Churruca is a serious named Buenos Aires campus on the public registry. ALL n=10 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, investigator’s brochure (IB), informed consent form (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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Churruca Buenos Aires 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, insurance coordinator, 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 Italiano de Buenos Aires or other CABA hospitals?

    No. Those are distinct Buenos Aires campus pages when live. This page is Hospital Churruca / Churruca-Visca only.

    Did bioaccess® run NCT00026338?

    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. Argentina sibling: other Buenos Aires campus pages on the bioaccess® blog.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidad Católica del Maule Talca: The NCT Campus String Is Not the ISP File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Universidad Católica del Maule Talca as a bioaccess® client.

    If you searched Universidad Catolica del Maule Talca first-in-human, Universidad Católica del Maule clinical trial, UCM Talca device study, or “go direct Universidad Católica del Maule Talca,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Católica del Maule in Talca, Chile (including the Campus San Miguel spelling on the registry), is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for this institution exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 campus still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Talca Universidad Católica del Maule university string. It is DISTINCT from Centro de Investigación del Maule Talca, from Hospital Clínico Universidad Católica Santiago (CMS — Hospital Clínico Universidad Católica), and from other Maule or Católica campuses. Sharing Talca or Católica is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Talca, Chile. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Universidad Católica del Maule (Talca, Chile) — registry strings counted: “Universidad Catolica del Maule”; “Universidad Católica del Maule”; “Universidad Católica del Maule – Campus San Miguel”. ALL studies n=10; interventional n=9; DEVICE n=2. Example NCT IDs: NCT02692911, NCT04251728, NCT05456282.

    Aliases including Campus San Miguel are counted once per NCT ID for Talca locations; 1 of the 10 are observational.

    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 campus as a client site.

    That is the leak: a founder searching Universidad Católica del Maule in Talca finds ALL n=10 (DEVICE n=2) without finding ISP. 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 campus 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 campus 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 campus is not built to own for an investigational device:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Universidad Católica del Maule is not a Centro de Investigación del Maule file and is not an ISP 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ISP actually works (the short version)

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

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

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

    Not a critique of the university

    Universidad Católica del Maule is a serious named Talca campus on the public registry. ALL n=10 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, investigator’s brochure (IB), informed consent form (ICF), insurance, and the ISP / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Universidad Católica del Maule Talca directly for a device FIH?

    You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurance coordinator, 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 campus. We will not invent that claim. This page answers the search; it does not claim the studies.

    Is this the same page as Centro de Investigación del Maule Talca?

    No. Centro de Investigación del Maule Talca is a distinct Talca research-center page already published. This page is the Universidad Católica del Maule university string only.

    Did bioaccess® run NCT02692911?

    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. Talca sibling (do not merge): Centro de Investigación del Maule Talca.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Cardiologia de Santa Catarina (São José): The NCT Campus String Is Not the ANVISA File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Instituto de Cardiologia de Santa Catarina as a bioaccess® client.

    If you searched Instituto de Cardiologia de Santa Catarina first-in-human, ICSC Sao Jose clinical trial, Instituto Cardiologia Santa Catarina device study, or “go direct Instituto de Cardiologia de Santa Catarina,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Cardiologia de Santa Catarina in São José, Santa Catarina, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (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, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Instituto de Cardiologia de Santa Catarina campus. It is DISTINCT from Instituto de Cardiologia do Rio Grande do Sul, Instituto Nacional de Cardiologia Rio de Janeiro, Instituto Nacional de Cardiología Ignacio Chávez (Mexico), and Florianópolis / Joinville campuses already published. Sharing the word Cardiologia or Santa Catarina is not a license to collapse them.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in São José, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Instituto de Cardiologia de Santa Catarina (São José, Brazil) — registry strings counted: “Instituto de Cardiologia de Santa Catarina”. ALL studies n=12; interventional n=11; DEVICE n=1. Example NCT IDs: NCT01741558, NCT01754675, NCT02343276.

    Counted once per NCT ID for São José locations; 1 of the 12 are observational.

    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 Instituto de Cardiologia de Santa Catarina in São José finds ALL n=12 (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 ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Instituto de Cardiologia de Santa Catarina is not an Instituto de Cardiologia do Rio Grande do Sul file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

    Not a critique of the hospital

    Instituto de Cardiologia de Santa Catarina is a serious named São José campus on the public registry. ALL n=12 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Instituto de Cardiologia de Santa Catarina 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, insurance coordinator, 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 Instituto de Cardiologia do Rio Grande do Sul?

    No. That is a different state and a different campus string. This page is Instituto de Cardiologia de Santa Catarina in São José only.

    Did bioaccess® run NCT01741558?

    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. Brazil cardiology sibling (do not merge): PROCAPE Recife.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Hospital Dr. Hernán Henríquez Aravena Temuco: The NCT Campus String Is Not the ISP File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital Dr. Hernán Henríquez Aravena Temuco as a bioaccess® client.

    If you searched Hospital Hernan Henriquez Aravena Temuco first-in-human, Hospital Dr Hernán Henríquez Aravena clinical trial, Temuco hospital device study, or “go direct Hospital Dr. Hernán Henríquez Aravena Temuco,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Dr. Hernán Henríquez Aravena in Temuco, Chile, is a real named hospital-campus string on ClinicalTrials.gov, registered under several accent and abbreviation spellings. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Temuco Hospital Dr. Hernán Henríquez Aravena campus. It is DISTINCT from Hospital Clínico Universidad de La Frontera Temuco strings, from Clínica Alemana Temuco, and from Santiago ISP-path campuses already published. Sharing Temuco or a regional health service is not a license to collapse them.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Temuco, Chile. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Hospital Dr. Hernán Henríquez Aravena (Temuco, Chile) — registry strings counted: “Hospital Dr Hernan Henriquez Aravena”; “Hospital Dr Hernán Henríquez Aravena”; “Hospital Dr. Hernan Henriquez Aravena”; “Hospital Dr. Hernán Henríquez Aravena”; “Hospital Hernan Henriquez Aravena”; “Hospital Hernán Henríquez Aravena”. ALL studies n=16; interventional n=11; DEVICE n=1. Example NCT IDs: NCT00412893, NCT00413218, NCT00467857.

    Aliases are counted once per NCT ID for Temuco locations; 5 of the 16 are observational. We do not invent a combined Universidad de La Frontera count on this page.

    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 Dr. Hernán Henríquez Aravena in Temuco finds ALL n=16 (DEVICE n=1) without finding ISP. 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:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Hospital Dr. Hernán Henríquez Aravena is not a Universidad de La Frontera file and is not an ISP 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How ISP actually works (the short version)

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

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

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

    Not a critique of the hospital

    Hospital Dr. Hernán Henríquez Aravena is a serious named Temuco campus on the public registry. ALL n=16 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, investigator’s brochure (IB), informed consent form (ICF), insurance, and the ISP / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Hospital Dr. Hernán Henríquez Aravena Temuco directly for a device FIH?

    You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurance coordinator, 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 Universidad de La Frontera Temuco?

    No. This page is the named Hospital Dr. Hernán Henríquez Aravena campus only. A university-string page is a different page if and when it is live.

    Did bioaccess® run NCT00412893?

    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. Chile sibling (do not merge): Hospital Clínico San Borja Arriarán Santiago.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Western Medical Center (IMSS Centro Médico Nacional de Occidente) Guadalajara: The NCT Campus String Is Not the COFEPRIS File

    Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Mexico’s Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Western Medical Center (IMSS CMNO) Guadalajara as a bioaccess® client.

    If you searched Western Medical Center IMSS Guadalajara first-in-human, Centro Medico Nacional de Occidente clinical trial, CMNO Guadalajara device study, or “go direct Western Medical Center (IMSS CMNO) Guadalajara,” you followed a campus string ClinicalTrials.gov still publishes. Western Medical Center of the Mexican Institute of Social Security (IMSS) in Guadalajara, Mexico — also registered as Centro Médico Nacional de Occidente and Centro Médico de Occidente-IMSS — is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (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, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Guadalajara IMSS Western Medical Center / Centro Médico Nacional de Occidente campus. It is DISTINCT from Centro de Investigación Médica de Occidente in Zapopan, from Hospital Ángeles Andares Guadalajara, and from other IMSS strings in other cities. Sharing the word Occidente or Guadalajara is not a license to collapse them. The English Western Medical Center spelling and the Spanish CMNO spellings are the same Guadalajara campus counted once per NCT ID.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

    Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Guadalajara, Mexico. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Western Medical Center, Mexican Institute of Social Security (Guadalajara, Mexico) — registry strings counted: “Centro Medico Nacional de Occidente”; “Centro Medico de Occidente-IMSS”; “Centro Médico Nacional de Occidente”; “Western Medical Center, Mexican Institute of Social Security”. ALL studies n=20; interventional n=16; DEVICE n=1. Example NCT IDs: NCT00026078, NCT00129142, NCT00336791.

    Aliases (Western Medical Center; Centro Médico Nacional de Occidente; Centro Médico de Occidente-IMSS) are counted once per NCT ID for Guadalajara locations; 4 of the 20 are observational.

    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 Western Medical Center or Centro Médico Nacional de Occidente in Guadalajara finds ALL n=20 (DEVICE n=1) without finding COFEPRIS. 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:

    • COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation at CMNO Guadalajara is not a Zapopan Occidente research-center file and is not a COFEPRIS 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
    • ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

    How COFEPRIS actually works (the short version)

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

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

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

    Not a critique of the hospital

    Western Medical Center / Centro Médico Nacional de Occidente is a serious named Guadalajara IMSS campus on the public registry. ALL n=20 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, investigator’s brochure (IB), informed consent form (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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. 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 in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Western Medical Center (IMSS CMNO) Guadalajara 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, insurance coordinator, 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 Centro de Investigación Médica de Occidente Zapopan?

    No. Centro de Investigación Médica de Occidente Zapopan is a distinct Zapopan page already published. This page is the Guadalajara IMSS Western Medical Center / CMNO campus only.

    Did bioaccess® run NCT00026078?

    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. Occidente sibling (do not merge): Centro de Investigación Médica de Occidente Zapopan.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • LATAM rapid-startup archetypes: Chile, Costa Rica, Panama, and El Salvador selection matrix

    Four countries. Two archetypes. One decision: which startup design matches the evidence your board, QA, and first-patient-in date actually need.

    I am Julio Martinez-Clark, CEO of bioaccess®. This is Part 3 of the Latin America rapid-startup archetypes series — the comparative framework for Chile, Costa Rica, Panama, and El Salvador. Part 1: pure ethics committee approval. Part 2: parallel review models. Corridor overview: fast-track FIH corridor. Indicative clocks only — confirm on filing day. Not legal advice.

    The two archetypes side by side

    Dimension Pure ethics (Chile & Costa Rica) Parallel review (Panama & El Salvador)
    What authorizes trial start Accredited CEC / IRB decision Ethics + national authority, concurrent
    Ministry / regulator role on the protocol No sequential ministry protocol-science queue; import / registry logistics follow ethics MINSA (Panama) or SRS (El Salvador) evaluate alongside ethics
    Primary instruments Chile: Ley 20.120, Decreto 114. Costa Rica: Ley 9234 / CONIS-accredited CEC Panama: Decreto Ejecutivo 21/2026 Art. 91, Type II CBI, RESEGIS. El Salvador: SRS-CNEIS-ES
    Statutory / typical ethics clock Chile CEC: 45 calendar days (extendable once by 20 for founded reasons). Costa Rica: CONIS-accredited CEC + CONIS registration Panama: parallel ethics + MINSA; ~30–45 day startup when complete. El Salvador: CNEIS pleno ~4–6 weeks; overall ~30–60 days
    Submission logistics Ethics package first; then ISP import (Chile) or CONIS registry (Costa Rica) One concurrent package into dual desks (RESEGIS/CBI or SRS-CNEIS-ES)
    Best when you need Clean ethics authorization without buying a ministry science co-signature Authority validation without sequential backlog

    Country cards for Clinical Ops, CMOs, and RA Directors

    Chile

    • Archetype: Pure ethics.
    • Clock to watch: Accredited CEC under Decreto 114 — 45 calendar days from complete submission.
    • Ministerial involvement: Not an ANAMED-style pharma IND sequential review for devices. ISP issues investigational-device import / provisional research-use authorization based on CEC clearance.
    • Operational lead time to FPI: Ethics calendar + ISP import readiness + site director authorization. Plan weeks after a clean CEC letter, not months of ministry protocol science.
    • Select Chile when: You want a statutory ethics clock, strong data-rigor perception, and a device path that does not wait on centralized pharma IND machinery.

    Costa Rica

    • Archetype: Pure ethics.
    • Clock to watch: Written approval from a CONIS-accredited CEC, then CONIS registration before execution.
    • Ministerial involvement: CONIS sits under the Ministry of Health structure for accreditation and registry. MINSA does not run a sequential protocol scientific review after ethics as the critical path.
    • Operational lead time to FPI: CEC decision + CONIS registration + site institutional authorization. Combined ethics-plus-registry work commonly lands in a weeks-to-low-months band when the Spanish file is complete — ask for a study-specific calendar.
    • Select Costa Rica when: You want Central American infrastructure, English-friendly operations, and an ethics-led start without inventing a ministry co-review that the archetype does not sell.

    Panama

    • Archetype: Parallel review.
    • Clock to watch: Decreto Ejecutivo 21/2026 Art. 91 — MINSA and CNBI-accredited Type II CBI evaluate simultaneously via RESEGIS mechanics. Complete-file startup often ~30–45 days.
    • Ministerial involvement: Explicit and concurrent. Registration on RESEGIS is mandatory before execution.
    • Operational lead time to FPI: Parallel clearance + import / DNFD touches where required + site activation. The sprinter reputation is real when the dossier is Spanish-complete on day one.
    • Select Panama when: You need ministry evaluation on the protocol and still need a weeks-scale startup. Use Type II, not Type I.

    El Salvador

    • Archetype: Parallel review.
    • Clock to watch: Unified SRS-CNEIS-ES submission; CNEIS pleno ~4–6 weeks; overall clearance typically 30–60 days.
    • Ministerial / authority involvement: SRS and CNEIS review concurrently from one digital file.
    • Operational lead time to FPI: Platform clearance + hospital contracting + import readiness. Cost position is often favorable versus Panama; population depth still constrains recruitment modeling.
    • Select El Salvador when: You want one ethics body, one regulator, one submission — authority validation without sequential delay.

    Selection matrix — five filters before you pick

    1. Do you need a national regulator’s protocol evaluation on the docket?
      Yes → Panama or El Salvador. No → Chile or Costa Rica.
    2. Is your pain sequential backlog or ethics capacity?
      Sequential backlog → parallel archetype. Ethics calendar / Spanish file quality → fix the dossier before you change countries.
    3. Device vs drug path?
      Chile’s device story (outside ANAMED pharma IND; ISP import after CEC) is a specific MedTech advantage. Confirm drug paths separately — do not copy-paste the device matrix onto every IND.
    4. Recruitment honesty
      All four corridor countries are smaller than Brazil, Mexico, or Colombia. Fast startup is worthless if screening math is fiction. Model prevalence before you celebrate a 45-day ethics clock.
    5. Import and site reality
      FPI is ethics/regulator clearance plus device or drug on site plus contracts signed. Parallel review does not ship inventory. Pure ethics does not either.

    Indicative lead times to first-patient-in

    Use these as planning bands for early-phase programs with a complete Spanish dossier, not as guarantees:

    • Chile: CEC 45-calendar-day frame + ISP import + site authorization → often a weeks-scale path after complete ethics submission.
    • Costa Rica: CONIS-accredited CEC + CONIS registration + site authorization → weeks to low months depending on committee cadence and file quality.
    • Panama: Parallel Type II + MINSA via RESEGIS → ~30–45 days to clearance on a complete file; FPI follows import and site readiness.
    • El Salvador: SRS-CNEIS-ES concurrent review → typically 30–60 days to clearance; CNEIS pleno often 4–6 weeks inside that band.

    If someone sells you “15 days to FPI” without naming dossier completeness, import status, and site contracts, they are selling a press line, not an operating plan. bioaccess® has activated fast Panama files; we still separate clearance clocks from first-patient clocks.

    How this series maps to the corridor post

    The corridor article answers “why these four countries feel fast.” This series answers “which legal design are you buying.” Speed without archetype clarity produces the wrong country for the wrong diligence question. Put both documents in the same diligence binder.

    Worked examples (no client names)

    Example A — implantable early feasibility, US IDE still months out. Board wants first-in-human data and does not require a ministry co-signature on the protocol science. Chile’s CEC clock under Decreto 114 plus ISP import after CEC is the cleaner fit than forcing a parallel-review country for optics.

    Example B — injectable or higher-visibility program where RA wants regulator eyes on the protocol. Panama Art. 91 parallel evaluation or El Salvador SRS-CNEIS-ES concurrent review answers the diligence question without a 6–12 month sequential stack.

    Example C — multi-country early program. Use Costa Rica or Chile for an ethics-led first site while a Panama or El Salvador file runs in parallel for authority-validated evidence. That is portfolio design. It is not “pick the fastest logo.”

    Diligence questions to send your CRO

    1. Which archetype are you selling me, in one sentence, with the named statute or platform?
    2. What starts the clock — complete-file date or first email?
    3. What is explicitly not included in the clearance clock (import, contracts, pharmacy)?
    4. For Panama: Type II CBI name and RESEGIS registration owner?
    5. For El Salvador: who holds the SRS-CNEIS-ES account and who answers queries inside the platform?
    6. For Chile: which accredited CEC and what is the ISP import dependency after the CEC letter?
    7. For Costa Rica: which CONIS-accredited CEC and when does CONIS registration occur relative to site activation?

    If the answers smear archetypes together, restart the country conversation before you restart the translation budget.

    Operator recommendation

    • MedTech FIH founder avoiding US IDE queue, wants ethics-led start: start with Chile or Costa Rica (Part 1).
    • Sponsor whose QA/RA needs concurrent authority evaluation: start with Panama or El Salvador (Part 2).
    • Portfolio with mixed programs: do not force one archetype. Match each protocol to the filter list above.

    bioaccess® — the First-in-Human CRO for medical devices in Latin America since 2010 — builds the dossier to the archetype you chose, not the one that sounds faster in a slide. Global Trial Accelerators™ and the country hubs on bioaccessla.com exist so your team can verify clocks against named instruments: Ley 20.120, Decreto 114, Ley 9234 / CONIS, Decreto Ejecutivo 21/2026 Art. 91, SRS-CNEIS-ES.

    Talk with bioaccess® when you need the four-country matrix turned into a study-specific startup calendar with Spanish file ownership, import sequencing, and an honest FPI date.

  • Parallel review in Panama and El Salvador: cutting sequential clinical trial backlogs

    Sequential startup is the silent killer of early-phase calendars. Ethics finishes. Then the ministry opens the protocol. Then someone asks for a Spanish annex you already had. Six to twelve months disappear before first-patient-in.

    I am Julio Martinez-Clark, CEO of bioaccess®. Panama and El Salvador sit in the second rapid-startup archetype: parallel review. Centralized authorities evaluate protocols at the same time as ethics committees. You still clear both gates. You stop waiting for them in series.

    This is Part 2 of the Latin America rapid-startup archetypes series. Part 1 covered pure ethics committee approval in Chile and Costa Rica. Part 3 is the comparative selection matrix. Corridor context: fast-track FIH corridor. Not legal advice — confirm the pathway on filing day.

    The archetype in one sentence

    Parallel review means the regulator and the ethics body work the same protocol package concurrently, so the traditional 6–12 month sequential backlog never becomes your critical path.

    Sponsors who need a national authority’s validation on the docket — without paying for that validation in serial months — belong here.

    Panama: Decreto Ejecutivo 21/2026, Art. 91, Type II CBIs, RESEGIS

    On 23 April 2026 Panama published Decreto Ejecutivo No. 21 (Gaceta Oficial No. 30510-C), implementing Titles III and IV of Ley 84 of 14 May 2019. For startup design, three pieces matter more than the rest of the decree:

    • RESEGIS — MINSA’s web platform for registro y seguimiento of health-research projects. Studies register before execution; the public docket is real, not folklore.
    • CNBI-accredited Type II CBIs — clinical trials go to Type II Comités de Bioética de la Investigación accredited by the national committee (CNBI). Ordinary ethics clocks are defined in the decree (including a 20-business-day ordinary review frame for complete files).
    • Artículo 91 parallel evaluation — for the high-risk / clinical-trial line, MINSA’s evaluation and the accredited Type II CBI review run simultaneously. The ministry review does not freeze the ethics clock.

    Operationally, that is why Panama startup compresses into roughly 30–45 days when the Spanish file is complete and the Type II committee is correctly selected. Parallelism is the design. Incomplete dossiers are still the failure mode.

    Operator checklist for Panama:

    1. Confirm the ethics destination is a CNBI-accredited Type II CBI. Type I is the wrong lane for interventional trials.
    2. Register the project in RESEGIS on the decree’s timeline — do not treat ethics approval as a substitute for registration.
    3. Submit a Spanish package that both MINSA and the CBI can review without translation theater: protocol, IB, consent, insurance, investigator and site docs.
    4. Plan import / pharmacy (including DNFD touchpoints where the product path requires them) as logistics that ride the RESEGIS + ethics + authorization chain — not as a surprise third sequential science review.
    5. Read the public RESEGIS list if you want proof the country is not opaque. The docket is an Excel-shaped reality, not a black box.

    Deeper Panama notes already published on the site: Decreto 21 of 2026 explained, CNBI / Type II procedure checklist, RESEGIS public trial docket, and functional animal studies vs Decreto 21.

    El Salvador: SRS-CNEIS-ES unified digital submission

    El Salvador’s parallel model is digital by design. Sponsors submit through the SRS-CNEIS-ES platform. One structured submission feeds both:

    • SRS — Superintendencia de Regulación Sanitaria (the national sanitary regulator; successor posture to the former DNM for this work), and
    • CNEIS — Comité Nacional de Ética de la Investigación en Salud.

    SRS and CNEIS review concurrently. You are not waiting for ethics to finish before the regulator opens the file, or the reverse. CNEIS pleno review commonly runs on a 4–6 week cadence; overall clearance for a complete international protocol typically lands in 30–60 days.

    That combination — one ethics body with national authority for international pharmaceutical / clinical protocols, one regulator, one digital submission — is why sponsors who want authority validation without sequential delay keep El Salvador on the short list.

    Operator checklist for El Salvador:

    1. Create the SRS-CNEIS-ES account and roles before you promise a board date. Platform access is part of the critical path.
    2. Upload a complete package on the first pass. Parallel review punishes incompleteness twice — both desks ask at once.
    3. Track status inside the platform. Do not invent a parallel email channel that splits the audit trail.
    4. Separate trial authorization from commercial registro thinking. A FIH clearance is not a marketing authorization; keep the investigational file off the commercial hold pattern.
    5. Model hospital fees and site activation as a second workstream. Regulatory parallelism does not auto-complete contracting.

    Related El Salvador posts: FIH step-by-step guide, CNEIS/SRS trial authorization vs registro.

    Parallel review vs pure ethics — choose on purpose

    Parallel review is not “better” than Chile/Costa Rica’s pure-ethics archetype. It is a different product.

    • Buy parallel review when your investors, notified body, or internal QA want a national regulator’s concurrent evaluation on the protocol — and you refuse to pay for that with a sequential backlog.
    • Buy pure ethics when the CEC letter is the authorization you need to open sites, and ministry involvement is import / registry logistics rather than protocol science.

    Confusing the two produces bad decks: Chile sold as “ministry co-approval,” or Panama sold as “ethics only.” Neither story survives diligence.

    What still kills the 30–45 / 30–60 day windows

    Parallelism removes waiting between desks. It does not remove:

    • Incomplete Spanish informed consent or IB
    • Wrong ethics destination (Panama Type I vs Type II)
    • Missing insurance or site letters
    • Import / customs readiness that starts the week you hoped to screen
    • Honest recruitment math in smaller populations

    bioaccess® will tell you the clock on the statute and the clock on your file. They are not the same number until the dossier is complete.

    Submission logistics that make parallelism real

    Parallel review fails in the same place sequential review fails: the first incomplete upload. The difference is you learn it from two desks at once.

    For Panama, treat RESEGIS registration, Type II CBI submission, and MINSA evaluation as one workstream with shared Spanish source files. Assign a single document controller. Version the protocol once. Do not let the ethics PDF and the ministry PDF drift by a forgotten amendment.

    For El Salvador, the SRS-CNEIS-ES platform is the workstream. Role setup, document taxonomy, and in-platform responses are part of Good Clinical Practice hygiene, not IT busywork. If your team answers SRS questions by WhatsApp and CNEIS questions by email, you have rebuilt sequential chaos on top of a parallel system.

    Import readiness belongs on the same Gantt row as review. A 35-day clearance with a device still on a US loading dock is not a 35-day path to first-patient-in. bioaccess® sequences customs, temperature control, and site pharmacy qualification against the expected clearance week — not against hope.

    Audience fit

    This archetype is for sponsors seeking regulatory-authority validation without sequential approval delays — Clinical Operations VPs and Regulatory Affairs leads who must show a ministry or superintendencia touch on the protocol while still protecting a FIH calendar measured in weeks.

    Next: Part 3 — comparative framework and selection matrix across all four countries.

    Talk with bioaccess® when you need a Panama RESEGIS + Type II file or an El Salvador SRS-CNEIS-ES package built for concurrent review — the First-in-Human CRO posture we have held in Latin America since 2010.

  • Pure ethics committee approval in Chile and Costa Rica: zero ministry bottleneck

    If you are a US or EU MedTech or biotech founder staring at the US investigational device exemption (IDE) queue, the first question is usually wrong. The question is not “which Latin American country is fastest.” The question is which archetype of startup you are buying.

    I am Julio Martinez-Clark, CEO of bioaccess®. Chile and Costa Rica sit in the first archetype: pure ethics committee approval. For early-phase medical device and many biopharma programs, an accredited ethics committee (CEC / IRB) is the gate that authorizes clinical operations at research sites. The Ministry of Health does not run a sequential scientific review of the protocol the way a classic agency IND path does.

    This article is Part 1 of a three-part series on Latin America’s rapid-startup archetypes (Chile, Costa Rica, Panama, El Salvador). Part 2 covers parallel review in Panama and El Salvador. Part 3 is the selection matrix. Companion corridor overview: Latin America’s fast-track FIH corridor. General information only — not legal advice. Confirm the filing-day pathway before you lock a calendar.

    The archetype in one sentence

    In Chile and Costa Rica, you get to first-patient-in by clearing an accredited ethics committee — not by waiting for a ministry to finish a separate protocol science queue after ethics is done.

    That does not mean “no paperwork” and it does not mean “no import file.” It means the protocol’s scientific and ethical authorization lives in the CEC / IRB layer. Import and site logistics ride on that clearance instead of sitting behind a second ministry protocol evaluation.

    Chile: Ley 20.120, Decreto 114, and the 45-day CEC clock

    Chile’s human-research frame is Ley 20.120 and its regulation, Decreto 114. Accredited Comités Ético Científicos (CECs) evaluate protocols under a statutory clock: 45 calendar days from a complete submission, with a single founded extension of 20 days available under the regulation. That clock is the planning number sponsors should put on the Gantt chart for ethics — not a marketing estimate.

    For medical devices, the early-phase path is structurally different from a pharmaceutical IND-style review at ANAMED. Device studies sit outside ANAMED’s centralized pharma investigational-product review. The Instituto de Salud Pública (ISP) role that matters for startup is the investigational-device import / provisional research-use authorization that follows CEC clearance. In practice: get the accredited CEC letter first; then work the ISP import file on the back of that clearance. Do not model Chile as “Ministry evaluates the protocol for six months, then ethics starts.”

    Operator implications for Chile:

    • Pick an accredited CEC early and map its meeting calendar. The statute gives you a day count; institutional agendas still decide when your file is complete enough to start the clock.
    • Spanish protocol, informed consent, and investigator’s brochure quality decide whether you burn the 45-day window on questions or clear it once.
    • Treat ISP as the import / research-use authority after CEC — not as a second sequential protocol science gate in the ANAMED drug sense.
    • Site director authorization under the Chilean regulation is a real step. Budget it after CEC (and after ISP when your product path requires it).

    For device-specific ISP investigation vs commercial registro nuance, see our live notes on Chile ISP clinical trial path for medical devices and why ISP treats device and drug trials differently.

    Costa Rica: CONIS-accredited CEC as the authorization to start

    Costa Rica’s Biomedical Research Law (Ley N.° 9234) and its regulations put written approval from a CONIS-accredited Comité Ético Científico at the center of trial initiation. CONIS (Consejo Nacional de Investigación en Salud), under the Ministry of Health, accredits the committees and runs the national protocol registry. That is not the same thing as MINSA running a sequential scientific review of every protocol after ethics.

    For sponsors evaluating FIH / early feasibility outside the US IDE queue, the operational read is:

    • A CONIS-accredited local CEC approves the protocol in writing.
    • The approved project is registered with CONIS before execution activities begin.
    • MINSA does not insert a second, sequential ministry protocol science review of the kind that creates 6–12 month backlogs in sequential markets.

    Phase I and certain ministry-housed CEC paths exist inside the Costa Rican system — confirm filing class on day one. For most early-phase MedTech and biotech founders comparing corridors, the archetype still holds: ethics accreditation is the authorization layer; CONIS registration is the national bookkeeping layer; you are not buying a ministry-after-ethics science queue.

    Operator implications for Costa Rica:

    • Confirm the CEC is CONIS-accredited before you translate a dossier for the wrong committee.
    • Build the Spanish file to ICH-GCP and, for devices, ISO 14155 expectations the committee actually uses.
    • Register with CONIS after CEC approval. Registration is not a substitute for the CEC letter.
    • Model hospital / site institutional authorization separately from the CEC decision.

    See also: Costa Rica FIH activation calendar (CEC, CONIS, canon) and the Costa Rica clinical trials hub.

    What “zero ministry bottleneck” does and does not mean

    Sponsors hear “only ethics” and invent two false stories. Correct both before you brief your board.

    False story 1: There is no government involvement at all.
    Reality: Chile still has ISP import / provisional research-use mechanics after CEC. Costa Rica still has CONIS accreditation and registration under the Ministry of Health structure. “Zero ministry bottleneck” means the ministry is not the sequential protocol-science gate that holds first-patient-in for half a year.

    False story 2: Ethics is a rubber stamp.
    Reality: Accredited CECs in both countries review risk-benefit, consent, insurance, investigator fitness, and protocol science. Incomplete Spanish files restart the clock. Pure-ethics archetypes are fast when the file is complete. They are not shortcuts around subject protection.

    Who this archetype fits

    US/EU MedTech and biotech founders evaluating FIH / early feasibility outside the US IDE queue usually fit Chile or Costa Rica when:

    • You want a clear ethics clock you can put in a financing deck (Chile’s 45-calendar-day CEC frame is the cleanest statutory example).
    • You accept that import / registry steps follow ethics instead of preceding a ministry protocol evaluation.
    • Your program benefits from strong data-rigor perception (Chile) or solid Central American infrastructure with English-friendly operations (Costa Rica), without needing a ministry scientific co-signature on the protocol itself.

    If your board or notified body specifically wants a national regulator’s concurrent protocol evaluation on the docket, look at Part 2 — Panama and El Salvador’s parallel-review archetype — not at stretching Chile or Costa Rica into something they are not.

    Practical startup sequence (both countries)

    1. Freeze the English protocol and IB; commission Spanish translations that a CEC can read without guessing.
    2. Select the accredited CEC (Chile) or CONIS-accredited CEC (Costa Rica) and obtain the current submission checklist and meeting calendar.
    3. Submit a complete ethics package: protocol, IB, informed consent, insurance, investigator CVs, site letters.
    4. Track the statutory or committee clock from the complete-file date, not from the first email.
    5. On favorable CEC decision, open the import / research-use file (Chile ISP) or CONIS registration (Costa Rica) without waiting for a ministry protocol science second pass that this archetype does not require.
    6. Close site contracts, pharmacy / device custody, and screening only after the country-specific start conditions are documented.

    How bioaccess® runs this archetype

    bioaccess® has been the First-in-Human CRO for medical devices in Latin America since 2010. On Chile and Costa Rica files we treat the CEC package as the critical path, keep ISP import or CONIS registration on a parallel logistics track after ethics, and refuse to sell you a sequential ministry fantasy that is not in the statute. When Global Trial Accelerators™ or a country hub on bioaccessla.com already covers a filing detail, we link it rather than invent a new clock.

    Next in this series: Parallel review models in Panama and El Salvador. Then the four-country selection matrix.

    Talk with bioaccess® when you need a Chile or Costa Rica FIH dossier built for the ethics clock you actually have — not the US IDE queue you are trying to step around.