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

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

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

This page is the named São Paulo research clinic. Distinct from CEPIC, Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing “pesquisa clínica” in the name is not a license to collapse them.

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

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

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

• CPQuali Pesquisa Clínica (São Paulo, Brazil): ALL interventional n=31; DEVICE n=0 on the ranking table. Example NCT IDs: NCT03740919, NCT03926130, NCT03987919.

We will not invent a DEVICE ranking from the top-40 CSV. We will not treat the words “Pesquisa Clínica” as proof this campus is your FIH operator.

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 “CPQuali São Paulo clinical trial” or “CPQuali Pesquisa Clínica FIH” finds ALL n=31 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, Einstein, HCor, or Santa Marcelina. A named research clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the clinic

CPQuali is a serious named São Paulo research clinic on the public registry. ALL n=31 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. It is separate from CEPIC, Einstein, HCor, or Santa Marcelina. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract CPQuali directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. CEPIC has its own page — a different named São Paulo investigative clinic. Einstein has its own page. HCor has its own page. Santa Marcelina has its own page. This page is CPQuali Pesquisa Clínica only. The named clinic is the site, not the CRO.

Is CPQuali the same as CEPIC?

No. CEPIC is Centro Paulista de Investigação Clínica. CPQuali is a different NCT facility string. Sharing São Paulo and sharing “clínica” in the name is not a merge.

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

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

Did bioaccess® run NCT03987919 because it also appears on CEPIC?

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

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched FAICIC Veracruz first-in-human, FAICIC Clinical Research Veracruz clinical trial, FAICIC S. de R.L. de C.V. CRO, or “go direct FAICIC Veracruz,” you followed a campus string ClinicalTrials.gov still publishes. FAICIC S. de R.L. de C.V. in Veracruz, Mexico, is a real named research-clinic string on ClinicalTrials.gov. FAICIC Clinical Research is a spelling of the same campus on this page. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Veracruz named research clinic. Distinct from INCMNSZ Salvador Zubirán, INCan, Centro de Investigación Clínica de Oaxaca, Hospital Civil de Guadalajara Fray Antonio Alcalde, UNAM Optometry Clinic, and Hospital Universitario Dr. José Eleuterio González. Veracruz is not Mexico City, not Oaxaca, not Guadalajara, and not Monterrey.

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

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

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

• FAICIC S. de R.L. de C.V. (Veracruz, Mexico) — canonical NCT string: ALL interventional n=31; DEVICE n=1. Example NCT IDs: NCT03950232, NCT04173273, NCT04642638.
• Spelling on this page only, no extra n: FAICIC Clinical Research. We list the alias so a founder searching that wording still lands here. We do not invent a second count. We do not publish a combined unique-study total.

We will not invent extra n for the Clinical Research spelling.

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 “FAICIC Veracruz clinical trial” or “FAICIC Clinical Research FIH” finds ALL n=31 (DEVICE n=1) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Oaxaca, Guadalajara, UNAM optometry, or Eleuterio González. A named Veracruz clinic is still not a CRO.

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

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

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

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

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

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

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

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 OUS FIH and FDA IDE.

Not a critique of the clinic

FAICIC is a serious named Veracruz research clinic on the public registry. ALL n=31 (DEVICE n=1) is registry volume, not a punchline. It is separate from INCMNSZ, INCan, Oaxaca, Guadalajara, UNAM optometry, or Eleuterio González. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract FAICIC Veracruz directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as INCMNSZ, INCan, Oaxaca, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González?

No. INCMNSZ has its own page (Mexico City). INCan has its own page (Mexico City). Oaxaca has its own page. Hospital Civil Guadalajara has its own page. UNAM optometry has its own page. Eleuterio González has its own page (Monterrey). This page is FAICIC S. de R.L. de C.V., Veracruz only. FAICIC Clinical Research is a spelling of this campus, not a second city.

Is FAICIC Clinical Research a different campus?

No. It is a spelling of FAICIC S. de R.L. de C.V. on this page. We do not invent a second n. We do not publish a combined total.

Is Veracruz under a different national agency than Mexico City?

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

Does DEVICE n=1 mean this clinic already owns COFEPRIS for a new device FIH?

No. A DEVICE n of 1 is a registry token. An NCT location row is not a COFEPRIS authorization. Keep trial clocks separate from registro.

Did bioaccess® run NCT04173273?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched CINME first-in-human, Centro de Investigaciones Metabólicas Buenos Aires clinical trial, CINME CRO Argentina, or “go direct CINME,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Metabólicas (CINME) in Buenos Aires, Argentina, is a real named metabolic-research facility string on ClinicalTrials.gov. We will not invent that CINME is a hospital CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This is the named Buenos Aires metabolic-research page. Distinct from Centro Médico Viamonte, CIPREC, Hospital Italiano de Buenos Aires, Fundación Respirar, Hospital Británico de Buenos Aires, and ENERI / Sagrada Familia. Sharing Buenos Aires is not a license to collapse them. CINME is the site. It is not the operator of the ANMAT file.

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

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

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

• Centro de Investigaciones Metabólicas (CINME) (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=32; DEVICE n=0 on the ranking table. Example NCT IDs: NCT03334435, NCT03535194, NCT03556202.

We will not invent a DEVICE ranking. We will not invent that this named research facility is a hospital CRO.

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 facility as a client site.

That is the leak: a founder searching “CINME Buenos Aires clinical trial” or “Centro de Investigaciones Metabólicas FIH” finds ALL n=32 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Viamonte, CIPREC, HIBA, Respirar, Británico, or ENERI. A named metabolic-research facility is still a site. An NCT location row is not a CRO.

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the facility

CINME is a serious named Buenos Aires metabolic-research facility on the public registry. ALL n=32 is registry volume, not a punchline, and not a claim that CINME is a hospital CRO. It is separate from Viamonte, CIPREC, HIBA, Respirar, Británico, or ENERI. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract CINME directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. Viamonte has its own page. CIPREC has its own page. HIBA has its own page. Fundación Respirar has its own page. Británico has its own page. ENERI / Sagrada Familia has its own page. This page is Centro de Investigaciones Metabólicas (CINME), Buenos Aires only. We will not invent that CINME is a hospital CRO.

Is CINME a hospital CRO because “Investigaciones” is in the name?

No. The NCT facility string is a site name. It is not ANMAT authorization, not an importer of record, and not ISO 14155 monitoring. We will not invent that CINME is a hospital CRO.

Does ALL n=32 mean this campus already owns ANMAT?

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

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE n.

Is this the same ALL-n=32 campus as Centro Médico Viamonte?

No. Viamonte has its own page — a different named clinic on a different street. Sharing an ALL n of 32 is a ranking coincidence, not a merge.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

This page is the named Buenos Aires clinic on Viamonte. Distinct from Hospital Italiano de Buenos Aires, Hospital Británico de Buenos Aires, CIPREC, Hospital Universitario Austral, ENERI / Sagrada Familia, and Fundación Respirar. Sharing Buenos Aires is not a license to collapse them.

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

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

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

• Centro Médico Viamonte (Buenos Aires, Argentina): ALL interventional n=32; DEVICE n=0 on the ranking table. Example NCT IDs: NCT03952143, NCT04184622, NCT04255433.

We will not invent a DEVICE ranking. We will not merge another Buenos Aires ALL-n=32 campus onto 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 clinic as a client site.

That is the leak: a founder searching “Centro Médico Viamonte clinical trial” finds ALL n=32 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Británico, CIPREC, Austral, ENERI, or Respirar. A named clinic on Viamonte is still not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the clinic

Centro Médico Viamonte is a serious named Buenos Aires clinic on the public registry. ALL n=32 is registry volume, not a punchline. It is separate from HIBA, Británico, CIPREC, Austral, ENERI/Sagrada Familia, or Fundación Respirar. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Centro Médico Viamonte directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as HIBA, Británico, CIPREC, Austral, ENERI, or Fundación Respirar?

No. HIBA has its own page. Británico has its own page. CIPREC has its own page. Austral has its own page. ENERI / Sagrada Familia has its own page. Fundación Respirar has its own page. This page is Centro Médico Viamonte only.

Is this the same clinic as CIPREC or ENERI?

No. CIPREC has its own page. ENERI has its own page. Viamonte is a different NCT string on a different named clinic.

Does ALL n=32 mean this clinic already owns ANMAT?

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

Did bioaccess® run NCT04184622 because it also appears on CEDOES?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. Buenos Aires sibling: Hospital Italiano de Buenos Aires.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Centro Medico Privado de Reumatologia first-in-human, Reumatologia Tucuman clinical trial, San Miguel de Tucumán CRO, or “go direct Centro Médico Privado de Reumatología,” you followed a campus string ClinicalTrials.gov still publishes. Centro Médico Privado de Reumatología in San Miguel de Tucumán, Argentina, is a real named rheumatology-clinic string on ClinicalTrials.gov. There is no earlier Tucumán page. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This is the Tucumán rheumatology-clinic page. Distinct from CIPREC and from Clínica La Sagrada Familia / ENERI. Those are Buenos Aires campuses. Tucumán is a different province. We will not invent a PI.

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

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

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

• Centro Medico Privado de Reumatologia (San Miguel de Tucumán, Argentina): ALL interventional n=32; DEVICE n=0 on the ranking table. Example NCT IDs: NCT00424476, NCT00650767, NCT00848354.

We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI.

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 “reumatología Tucumán clinical trial” or “Centro Médico Privado de Reumatología FIH” finds ALL n=32 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on CIPREC or ENERI. Tucumán is still not Buenos Aires, and a named clinic is still not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the clinic

Centro Médico Privado de Reumatología is a serious named Tucumán clinic on the public registry. ALL n=32 is registry volume, not a punchline. It is separate from CIPREC or ENERI. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

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

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as CIPREC or ENERI / Sagrada Familia?

No. CIPREC has its own page (Buenos Aires). ENERI / Clínica La Sagrada Familia has its own page (Buenos Aires). This page is Centro Médico Privado de Reumatología, San Miguel de Tucumán only. No earlier Tucumán page.

Is Tucumán under a different national agency than Buenos Aires?

No. ANMAT is still the national file. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate.

Does ALL n=32 mean this clinic is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. We will not invent a PI to fill a blank investigator field.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE n.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Sanatorio Parque Rosario first-in-human, Sanatorio Parque clinical trial Rosario, Sanatorio Parque CRO Argentina, or “go direct Sanatorio Parque,” you followed a campus string ClinicalTrials.gov still publishes. Sanatorio Parque in Rosario, Argentina, is a real sanatorium string on ClinicalTrials.gov. This page is Rosario only. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This is the Rosario Sanatorio Parque page. Distinct from Sanatorio Allende, Hospital Provincial del Centenario, and INECO Neurociencias Oroño (separate page). We do not merge Salta or Córdoba “Sanatorio Parque” strings — those are other cities. Sharing a commercial name across provinces is not a license to collapse them.

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

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

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

• Sanatorio Parque (Rosario, Argentina): ALL interventional n=32; DEVICE n=1. Example NCT IDs: NCT00269828, NCT00300274, NCT00597220.

Only the Rosario city field is used. We will not borrow Salta or Córdoba “Sanatorio Parque” rows onto this page. We will not invent a combined unique-study total across cities.

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

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

That is the leak: a founder searching “Sanatorio Parque clinical trial” finds a Rosario campus (ALL n=32; DEVICE n=1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Allende Córdoba, Centenario Rosario, or INECO. Rosario is still not Córdoba, not Salta, and 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. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA page.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the hospital

Sanatorio Parque in Rosario is a serious local resource. ALL n=32 (DEVICE n=1) is registry volume, not a punchline. It is separate from Allende Córdoba, Centenario Rosario, INECO, or into Salta/Córdoba strings that reuse the same commercial name. Use the Rosario site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Sanatorio Parque directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Sanatorio Allende, Centenario Rosario, INECO, or a Salta/Córdoba Sanatorio Parque?

No. Allende has its own page (Córdoba). Centenario has its own page (Rosario, different hospital). INECO Neurociencias Oroño is a separate Rosario page. Salta and Córdoba “Sanatorio Parque” strings are other cities; they are not merged here. This page is Sanatorio Parque, Rosario only.

Why not merge every “Sanatorio Parque” in Argentina?

City fields on ClinicalTrials.gov are part of the facility key. Rosario is not Salta and not Córdoba. Merging them would invent a multi-city combined count the ranking table does not state.

Is Rosario under a different national agency than Buenos Aires?

No. ANMAT is still the national file. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate.

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

No. A DEVICE n of 1 is a registry token. An NCT location row is not trial authorization.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Clinico Universidad de Chile first-in-human, UChile clinical hospital Santiago clinical trial, Hospital Clínico Universidad de Chile CRO, or “go direct Hospital Clínico Universidad de Chile,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Clínico Universidad de Chile in Santiago is the public Universidad de Chile (UChile) clinical hospital string on ClinicalTrials.gov. It is not Hospital Clínico Universidad Católica. It is not Universidad Andrés Bello. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the public Universidad de Chile clinical hospital. Distinct from Hospital Clínico Universidad Católica and from Universidad Andrés Bello. Católica is a different campus and a different query. UNAB is a different NCT university string. We do not repeat press-named TMVR claims from the Católica page onto this hospital. We will not invent a PI.

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

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

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

• Hospital Clínico Universidad de Chile (Santiago, Chile) — canonical NCT string: ALL interventional n=32; DEVICE n=4. Example NCT IDs: NCT01268423, NCT01739751, NCT02576574.
• Unaccented alias (same campus, same city): ALL n=27; DEVICE n=3. That alias is named here so a founder searching the unaccented spelling still lands on this page. We do not publish a second page. We do not add 32+27 or 4+3 as a combined unique-study total.

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 Clínico Universidad de Chile clinical trial” or “UChile FIH Santiago” finds a public campus string without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Clínico Universidad Católica or UNAB. A public clinical hospital is still not a CRO. We will not paste Católica press claims onto this page.

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 at this clinical hospital is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ISP actually works (the short version)

Use Clinical Trials 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 OUS FIH and FDA IDE.

Not a critique of the hospital

Hospital Clínico Universidad de Chile is a serious public clinical hospital. ALL n=32 (DEVICE n=4) on the ranking table is registry volume, not a punchline. The unaccented ALL=27 / DEVICE=3 row is a spelling alias, not a second hospital and not a combined total we invent. It is separate from Católica or UNAB. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Clínico Universidad de Chile directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. Católica has its own page. UNAB has its own page. This page is the public Universidad de Chile (UChile) clinical hospital only. We do not repeat press-named TMVR claims from the Católica page.

Why two ALL n values on one page?

ClinicalTrials.gov stored an accented canonical string (ALL n=32; DEVICE n=4) and an unaccented alias (ALL n=27; DEVICE n=3). This page covers both as one campus. It does not add the counts.

Is n=32 plus n=27 equal to 59 unique studies?

We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a combined total. Same rule for DEVICE 4+3.

Is this the Catholic university hospital?

No. That is Hospital Clínico Universidad Católica. This page is Universidad de Chile — a public university clinical hospital. Different rectorate. Different NCT strings.

Does ISP have PAHO/WHO Level 4 standing?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Centro de Investigacion Clinica de Oaxaca first-in-human, Oaxaca City clinical trial, CICO Oaxaca CRO, or “go direct Centro de Investigación Clínica de Oaxaca,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigación Clínica de Oaxaca in Oaxaca City, Mexico, is a real named research-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Oaxaca named research clinic. Distinct from INCMNSZ Salvador Zubirán, INCan, Hospital Civil de Guadalajara Fray Antonio Alcalde, UNAM Optometry Clinic, and Hospital Universitario Dr. José Eleuterio González. Oaxaca City is not Mexico City, not Guadalajara, not Monterrey, and not a UNAM optometry lab.

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

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

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

• Centro de Investigacion Clinica de Oaxaca (Oaxaca City, Mexico): ALL interventional n=33; DEVICE n=0 on the ranking table. Example NCT IDs: NCT03498716, NCT03899155, NCT04365868.

We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI.

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 “Oaxaca clinical trial clinic” or “Centro de Investigación Clínica de Oaxaca FIH” finds ALL n=33 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Guadalajara, UNAM optometry, or Eleuterio González. A named Oaxaca clinic is still not a CRO.

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

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

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

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

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

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

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

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 OUS FIH and FDA IDE.

Not a critique of the clinic

Centro de Investigación Clínica de Oaxaca is a serious named clinic on the public registry. ALL n=33 is registry volume, not a punchline. It is separate from INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Centro de Investigación Clínica de Oaxaca directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González?

No. INCMNSZ has its own page (Mexico City). INCan has its own page (Mexico City). Hospital Civil Guadalajara has its own page. UNAM optometry has its own page. Eleuterio González has its own page (Monterrey). This page is Centro de Investigación Clínica de Oaxaca, Oaxaca City only.

Is Oaxaca under a different national agency than Mexico City?

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

Does ALL n=33 mean this clinic already owns COFEPRIS?

No. An NCT location row is not a COFEPRIS authorization. Keep trial clocks separate from registro.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE n.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched INECO Neurociencias Orono first-in-human, INECO Rosario clinical trial, Neurociencias Oroño CRO, or “go direct INECO Neurociencias Oroño,” you followed a campus string ClinicalTrials.gov still publishes. INECO Neurociencias Oroño in Rosario, Argentina, is a real neuroscience-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This is the Rosario neuroscience-institute page. Distinct from Hospital Provincial del Centenario and from CIPREC. Rosario is not Buenos Aires. A neuroscience institute is not a provincial hospital. Linking is correct. Collapsing Santa Fe province into Buenos Aires, or collapsing every Rosario string into Centenario, is not.

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

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

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

• INECO Neurociencias Oroño (Rosario, Argentina): ALL interventional n=35; DEVICE n=0 on the ranking table. Example NCT IDs: NCT04634409, NCT04965675, NCT05164172.

We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI on this institute.

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

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

That is the leak: a founder searching “INECO Rosario clinical trial” or “Neurociencias Oroño FIH” finds ALL n=35 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Centenario Rosario or CIPREC. A Rosario neuroscience institute is still not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the institute

INECO Neurociencias Oroño is a serious Rosario neuroscience resource. ALL n=35 is registry volume, not a punchline. It is separate from Centenario Rosario or CIPREC. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract INECO Neurociencias Oroño directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Provincial del Centenario Rosario, CIPREC, or Sanatorio Parque Rosario?

No. Centenario has its own page. CIPREC has its own page (Buenos Aires). Sanatorio Parque Rosario has its own page and is not this institute. This page is INECO Neurociencias Oroño, Rosario only.

Is Rosario under a different national agency than Buenos Aires?

No. ANMAT is still the national file. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate.

Does ALL n=35 mean this institute is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package.

Is this the same campus as Sanatorio Parque?

No. Sanatorio Parque is a different Rosario NCT string (separate page, pick #8). Sharing a city is not a license to merge them.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched CEPIC Sao Paulo first-in-human, Centro Paulista de Investigação Clínica clinical trial, CEPIC CRO Brazil, or “go direct CEPIC,” you followed a campus string ClinicalTrials.gov still publishes. CEPIC — Centro Paulista de Investigação Clínica — in São Paulo, Brazil, is a real named investigative-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named São Paulo investigative clinic. The clinic is the site. It is not the CRO. Distinct from CIPREC Buenos Aires (a different country, a different regulator, a different acronym), Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing “investigative clinic” in the name is not a license to collapse them.

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

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

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

• CEPIC – Centro Paulista de Investigação Clínica (São Paulo, Brazil): ALL interventional n=35; DEVICE n=0 on the ranking table. Example NCT IDs: NCT01885078, NCT02689362, NCT03987919.

We will not invent a DEVICE ranking from the top-40 CSV. We will not treat the word “Investigação Clínica” as proof this campus is your FIH operator.

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 “CEPIC São Paulo clinical trial” or “Centro Paulista de Investigação Clínica FIH” finds ALL n=35 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CIPREC, Einstein, HCor, or Santa Marcelina. A named investigative clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the clinic

CEPIC is a serious named São Paulo investigative clinic on the public registry. ALL n=35 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. It is separate from CIPREC, Einstein, HCor, or Santa Marcelina. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract CEPIC directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. CIPREC has its own page in Buenos Aires (ANMAT). Einstein, HCor, and Santa Marcelina are separate São Paulo hospital pages. This page is CEPIC — Centro Paulista de Investigação Clínica — only. The named clinic is the site, not the CRO.

Is CEPIC the same as CIPREC?

No. CIPREC is Buenos Aires. CEPIC is São Paulo. Different letters, different country, different regulator.

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

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

Did bioaccess® run NCT03987919 because it also appears on another campus?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®