Category: First-in-Human

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 CEMEC São Bernardo as a bioaccess® client.

If you searched CEMEC São Bernardo first-in-human, Centro Multidisciplinar de Estudos Clínicos clinical trial, CEMEC São Bernardo do Campo CRO, or “go direct CEMEC São Bernardo,” you followed a campus string ClinicalTrials.gov still publishes. CEMEC – Centro Multidisciplinar de Estudos Clínicos in São Bernardo do Campo, Brazil, is a real named research-center string on ClinicalTrials.gov. São Bernardo do Campo is not São Paulo capital. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the São Bernardo do Campo named research center. Distinct from CEPIC, CPCLIN, and CPQuali. Sharing a “C” research-clinic prefix or sharing Greater São Paulo is not a license to collapse them. This is not a São Paulo capital campus.

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.

• CEMEC – Centro Multidisciplinar de Estudos Clínicos (São Bernardo do Campo, Brazil) — ranking row: ALL interventional n=26; DEVICE n=0. Example NCT IDs: NCT03057951, NCT03057977, NCT03071692.
• Checked against the 1 September 2026 ClinicalTrials.gov pull on the named campus string: unique NCT IDs n=28. Same campus. Not two centers. Counts for with other CEMEC spellings are kept separate.
• Alias Centro Multidisciplinar de Estudos Clinicos: ALL n=10. Listed separately. Same page. We do not invent a combined unique-study total of 26+28+10. We do not ship a second page for the unaccented expanded spelling.

These counts are not added together. DEVICE n=0; we will not pad it.

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

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

That is the leak: a founder searching “CEMEC São Bernardo clinical trial” or “Centro Multidisciplinar de Estudos Clínicos FIH” finds ALL n=26 (named-string n=28) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPCLIN, or CPQuali. São Bernardo do Campo is still not São Paulo capital. A named research center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 in São Bernardo do Campo is not a CEPIC, CPCLIN, or CPQuali 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 center

CEMEC in São Bernardo do Campo is a serious named research center on the public registry. ALL n=26 is registry volume, not a punchline. named-string n=28 is the same named string, not a second campus. We do not invent a DEVICE n. It is separate from CEPIC, CPCLIN, or CPQuali. 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract CEMEC São Bernardo directly for a device FIH?

You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as CEPIC, CPCLIN, or CPQuali?

No. CEPIC has its own page (São Paulo). CPCLIN is a São Paulo research-clinic page. CPQuali has its own page (São Paulo). This page is CEMEC in São Bernardo do Campo only. Alias ALL n=10 stays listed separately; ALL n=26 is ranking; named-string n=28 is the named string. We do not combine.

Should I add ALL n=26, named-string n=28, and alias ALL n=10?

No. ALL n=26 is the ranking row. named-string n=28 is the same named hospital string confirmed. Alias n=10 is listed separately. A combined unique-study total is not published.

Is CEMEC in São Paulo capital?

No. This campus is São Bernardo do Campo. CEPIC, CPCLIN, and CPQuali remain São Paulo-capital strings.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=26 is still not ANVISA authorization.

Did bioaccess® run NCT03057951?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in 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 ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital São Vicente de Paulo as a bioaccess® client.

If you searched Hospital São Vicente de Paulo Passo Fundo first-in-human, Hospital Sao Vicente de Paulo clinical trial, Passo Fundo CRO Brazil, or “go direct Hospital São Vicente de Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Hospital São Vicente de Paulo in Passo Fundo, Brazil, is a real named hospital string on ClinicalTrials.gov. Passo Fundo is not Porto Alegre and not Campinas. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Passo Fundo hospital. Distinct from Hospital São Lucas da PUCRS (Porto Alegre) and from Centro de Pesquisa Sao Lucas in Campinas (separate page). Sharing “Lucas” or sharing Rio Grande do Sul 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.

• Hospital São Vicente de Paulo (Passo Fundo, Brazil) — ranking / canonical accented NCT string: ALL interventional n=26; DEVICE n=0. Example NCT IDs: NCT01897532, NCT02576574, NCT02616068. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs n=26 on the Passo Fundo city string.
• Unaccented alias Hospital Sao Vicente de Paulo: ALL n=21. Listed separately. Same page. We do not invent a combined unique-study total of 26+21. We do not ship a second page for the unaccented spelling.

These counts are not added together.

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 São Vicente de Paulo Passo Fundo clinical trial” or the unaccented spelling finds ALL n=26 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on PUCRS São Lucas or Campinas São Lucas. Passo Fundo is still not Porto Alegre. A named hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the hospital

Hospital São Vicente de Paulo in Passo Fundo is a serious named hospital on the public registry. ALL n=26 is registry volume, not a punchline. We do not invent a DEVICE n. It is separate from PUCRS São Lucas or into Centro de Pesquisa Sao Lucas Campinas. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital São Vicente de Paulo directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital São Lucas da PUCRS or Centro de Pesquisa Sao Lucas Campinas?

No. PUCRS São Lucas has its own page in Porto Alegre. Campinas São Lucas has its own page. This page is Hospital São Vicente de Paulo, Passo Fundo only. Unaccented ALL n=21 stays listed separately; we do not combine them.

Should I add ALL n=26 and the unaccented ALL n=21?

No. Alias n is listed separately. A combined unique-study total is not published. The unaccented spelling is the same Passo Fundo campus on the same page.

Is this PUCRS São Lucas?

No. Hospital São Lucas da PUCRS is Porto Alegre. This page is Passo Fundo.

Is this Centro de Pesquisa Sao Lucas in Campinas?

No. That is a Campinas research-center string. Passo Fundo is a different city and a different NCT string.

Did bioaccess® run NCT01897532?

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

Next step

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

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 Hospital Cardiológica Aguascalientes as a bioaccess® client.

If you searched Hospital Cardiologica Aguascalientes first-in-human, Hospital Cardiológica Aguascalientes clinical trial, Aguascalientes cardiology CRO, or “go direct Hospital Cardiológica Aguascalientes,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Cardiologica Aguascalientes in Aguascalientes, Mexico, is a real named cardiology-hospital string on ClinicalTrials.gov. Aguascalientes is not Mexico City. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Aguascalientes cardiology hospital. It is not Instituto Nacional de Cardiología Ignacio Chávez in Mexico City. Different city. Different NCT string. Sharing “cardiológica” in a hospital 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.

• Hospital Cardiologica Aguascalientes (Aguascalientes, Mexico) — ranking / canonical NCT string: ALL interventional n=26. Example NCT IDs: NCT01975389, NCT02019264, NCT02104947. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs n=26 on this city string. DEVICE n=0 on the ranking table. The registry pull did not force a DEVICE n; we will not invent one.
• Typo alias Hospital Cardiologica Aguescalientes: ALL n=4. Listed separately. Same page. We do not invent a combined unique-study total of 26+4. We do not ship a second page for the typo.

These counts are not added together. We do not invent a DEVICE n.

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

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

That is the leak: a founder searching “Hospital Cardiológica Aguascalientes clinical trial” or the Aguescalientes typo finds ALL n=26 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on Instituto Nacional de Cardiología Ignacio Chávez in Mexico City. Aguascalientes is still not Mexico City. A named cardiology hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation in Aguascalientes is not an Ignacio Chávez Mexico City 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 committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 hospital

Hospital Cardiologica Aguascalientes is a serious named Aguascalientes cardiology resource on the public registry. ALL n=26 is registry volume, not a punchline. We do not invent a DEVICE n. It is separate from Instituto Nacional de Cardiología Ignacio Chávez. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Cardiológica Aguascalientes directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. Ignacio Chávez is a Mexico City national cardiology institute. This page is Hospital Cardiologica Aguascalientes only. The Aguescalientes typo stays on this page; we list ALL n=4 separately and do not combine them.

Should I add ALL n=26 and the typo ALL n=4?

No. Alias n is listed separately. A combined unique-study total is not published. The typo is the same Aguascalientes campus on the same page.

Why no DEVICE n?

DEVICE n=0 on the ranking table. The registry pull did not force a DEVICE n for this string. We will not invent one. ALL n=26 is still not COFEPRIS authorization.

Is Aguascalientes under a different national agency than Mexico City?

No. COFEPRIS is still the national file. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Registro sanitario (~30 working days) is a different file.

Did bioaccess® run NCT01975389?

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 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 Scientia Investigación Clínica Chihuahua as a bioaccess® client.

If you searched Scientia Investigacion Clinica Chihuahua first-in-human, Scientia Investigación Clínica S.C. clinical trial, Chihuahua CRO Mexico, or “go direct Scientia Investigación Clínica Chihuahua,” you followed a campus string ClinicalTrials.gov still publishes. Scientia Investigacion Clinica S.C. in Chihuahua 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 Chihuahua City named research clinic. Distinct from INCan, INCMNSZ Salvador Zubirán, Centro de Investigación Clínica de Oaxaca, FAICIC Veracruz, Hospital Civil de Guadalajara Fray Antonio Alcalde, and Hospital Universitario Dr. José Eleuterio González. Chihuahua City is not Mexico City, not Oaxaca, not Veracruz, not Guadalajara, not Monterrey, and not Estado de México.

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.

• Scientia Investigacion Clinica S.C. (Chihuahua City, Mexico) — ranking / canonical NCT string: ALL interventional n=26; DEVICE n=1. Example NCT IDs: NCT03518086, NCT03519945, NCT03524092. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs n=26 on the Chihuahua City string.

We do not invent a second Chihuahua page. We do not merge this clinic into a Mexico City national 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 clinic as a client site.

That is the leak: a founder searching “Scientia Chihuahua clinical trial” or “Scientia Investigación Clínica FIH” finds ALL n=26 (DEVICE n=1) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCan, INCMNSZ, Oaxaca, FAICIC, Guadalajara, or Eleuterio González. A named Chihuahua 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 committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation in Chihuahua City is not an INCMNSZ or FAICIC file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How COFEPRIS actually works (the short version)

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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

Scientia Investigacion Clinica S.C. is a serious named Chihuahua research clinic on the public registry. ALL n=26 (DEVICE n=1) is registry volume, not a punchline. It is separate from INCan, INCMNSZ, Oaxaca, FAICIC, Guadalajara, 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Scientia Investigación Clínica Chihuahua 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 INCan, INCMNSZ, Oaxaca, FAICIC, Hospital Civil Guadalajara, or Eleuterio González?

No. INCan has its own page (Mexico City). INCMNSZ has its own page (Mexico City). Oaxaca has its own page. FAICIC has its own page (Veracruz). Hospital Civil Guadalajara has its own page. Eleuterio González has its own page (Monterrey). This page is Scientia Investigacion Clinica S.C., Chihuahua City only.

Is Chihuahua under a different national agency than Mexico City?

No. COFEPRIS is still the national file. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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. DEVICE n is unique NCT IDs on the device filter for this facility string. It is not COFEPRIS authorization, not import, and not a 21 CFR 812.28 package.

Is Chihuahua the same campus as a Mexico City national institute?

No. INCan and INCMNSZ remain Mexico City strings. This page is Chihuahua City only.

Did bioaccess® run NCT03518086?

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 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 A.C. Camargo Cancer Center as a bioaccess® client.

If you searched A.C. Camargo Cancer Center first-in-human, Fundacao Antonio Prudente clinical trial, AC Camargo São Paulo CRO, or “go direct A.C. Camargo Cancer Center,” you followed a campus string ClinicalTrials.gov still publishes. Fundacao Antonio Prudente A C Camargo Cancer Center in São Paulo, Brazil, is a real named cancer-center 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Fundação Antonio Prudente / A.C. Camargo campus. Distinct from ICESP, Barretos Cancer Hospital, Hospital Sírio-Libanês, and Hospital Israelita Albert Einstein. Sharing São Paulo or sharing an oncology search 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.

• Fundacao Antonio Prudente A C Camargo Cancer Center (São Paulo, Brazil) — ranking / canonical NCT string: ALL interventional n=26; DEVICE n=1. Example NCT IDs: NCT03390504, NCT03748641, NCT03871829. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs n=26 on this canonical string.
• Alias AC Camargo Cancer Center: ALL n=20. Listed separately. Same page. No combined total.
• Alias A. C. Camargo Cancer Center: ALL n=14. Listed separately. Same page. No combined total.
• Alias A.C. Camargo Cancer Center: ALL n=9. Listed separately. Same page. No combined total.

Alias counts are listed separately. The 26+20+14+9 counts are not added together. We do not ship a second page for punctuation variants.

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

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

That is the leak: a founder searching “A.C. Camargo first-in-human” or “Fundacao Antonio Prudente clinical trial” finds ALL n=26 (DEVICE n=1) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, Sírio-Libanês, or Einstein. A named cancer center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 A.C. Camargo is not an ICESP, Barretos, Sírio, or Einstein 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 center

A.C. Camargo Cancer Center is a serious named São Paulo cancer center on the public registry. ALL n=26 (DEVICE n=1) is registry volume, not a punchline. It is separate from ICESP, Barretos, Sírio-Libanês, or Einstein. Counts for alias n are kept separate. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract A.C. Camargo Cancer Center directly for a device FIH?

You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as ICESP, Barretos, Sírio-Libanês, or Einstein?

No. ICESP has its own page. Barretos has its own page. Sírio-Libanês has its own page. Einstein has its own page. This page is Fundacao Antonio Prudente A C Camargo Cancer Center only. Alias n stays listed separately; we do not combine them.

Should I add ALL n=26, 20, 14, and 9?

No. Alias n is listed separately. A combined unique-study total is not published. Punctuation variants of A.C. Camargo stay on this page.

Does DEVICE n=1 mean this center already owns ANVISA for a new device FIH?

No. DEVICE n is unique NCT IDs on the device filter for the canonical facility string. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023. An NCT location row is not that file.

Is this ICESP or Barretos?

No. ICESP has its own page in São Paulo. Barretos has its own page. Sharing oncology is not a merge.

Did bioaccess® run NCT03390504?

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

Next step

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

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 Instituto de Neurologia de Curitiba as a bioaccess® client.

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

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

This page is the named Curitiba neurology institute. Distinct from Hospital Erasto Gaertner — same city, oncology hospital, different NCT string. Sharing Curitiba 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.

• Instituto de Neurologia de Curitiba (Curitiba, Brazil) — ranking row: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT00988429, NCT03085810, NCT03114657.
• Checked against the 1 September 2026 ClinicalTrials.gov pull on the same named campus string: unique NCT IDs n=28. That is the same campus string, not a second institute. Do not treat 27 and 28 as two campuses. We do not invent a combined count with any other Curitiba hospital.

Use ALL n=27 with the NCT IDs above as the ranking count. DEVICE n=0 on the ranking table; we will not pad it.

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

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

That is the leak: a founder searching “Instituto de Neurologia de Curitiba clinical trial” or “INC Curitiba FIH” finds ALL n=27 (same-string n=28) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Erasto Gaertner. A named neurology institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at this neurology institute is not an Erasto Gaertner oncology-hospital 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 institute

Instituto de Neurologia de Curitiba is a serious named Curitiba neurology resource on the public registry. ALL n=27 is registry volume, not a punchline. named-string n=28 is the same campus string confirm, not a second hospital. We do not invent a DEVICE n. It is separate from Erasto Gaertner. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto de Neurologia de Curitiba directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Erasto Gaertner?

No. Erasto Gaertner has its own page, a Curitiba oncology hospital. This page is Instituto de Neurologia de Curitiba only. ALL n=27 is the ranking row; named-string n=28 is the same named string, not a merge with Erasto.

Why ALL n=27 and named-string n=28?

The ranking table uses facility string + city + country (Curitiba). The named-string confirm is n=28 on the same campus string. They are not two institutes.

Is this Erasto Gaertner?

No. Erasto Gaertner is a different Curitiba hospital and a different NCT string. Oncology versus neurology-institute string is not a merge.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANVISA authorization.

Did bioaccess® run NCT00988429?

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

Next step

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

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 Centro de Pesquisa São Lucas Campinas as a bioaccess® client.

If you searched Centro de Pesquisa Sao Lucas first-in-human, São Lucas Campinas clinical trial, Centro de Pesquisa São Lucas CRO Brazil, or “go direct Centro de Pesquisa São Lucas Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Pesquisa Sao Lucas in Campinas, Brazil, is a real named research-center string on ClinicalTrials.gov. Campinas is not Porto Alegre. 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Campinas named research center. Distinct from Hospital São Lucas da PUCRS (Porto Alegre). It is also not Hospital São Vicente de Paulo in Passo Fundo (separate page). Sharing “São Lucas” in another city is not a license to collapse them. Campinas versus Porto Alegre is the whole point of the page.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), 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 Pesquisa Sao Lucas (Campinas, Brazil) — ranking row / canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT03899259, NCT04211337, NCT04232553. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs on this Campinas string n=27.
• Accented alias Centro de Pesquisa São Lucas (Campinas): ALL n=4. Listed separately. Same page. We do not invent a combined unique-study total of 27+4. We do not ship a second page for the accented spelling.

These counts are not added together. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “Centro de Pesquisa São Lucas Campinas clinical trial” or “São Lucas FIH Brazil” finds ALL n=27 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital São Lucas da PUCRS in Porto Alegre. Campinas is still not Porto Alegre. A named research center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 in Campinas is not a PUCRS São Lucas Porto Alegre 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 center

Centro de Pesquisa Sao Lucas in Campinas is a serious named research center on the public registry. ALL n=27 is registry volume, not a punchline. It is separate from Hospital São Lucas da PUCRS (Porto Alegre) or into Hospital São Vicente de Paulo (Passo Fundo). 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Centro de Pesquisa São Lucas Campinas directly for a device FIH?

You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Hospital São Lucas da PUCRS or Hospital São Vicente de Paulo Passo Fundo?

No. Hospital São Lucas da PUCRS has its own page in Porto Alegre. Hospital São Vicente de Paulo is a Passo Fundo page. This page is Centro de Pesquisa Sao Lucas, Campinas only. The accented alias ALL n=4 stays listed separately; we do not combine them.

Should I add ALL n=27 and the accented ALL n=4?

No. Alias n is listed separately. A combined unique-study total is not published. The accented spelling is the same Campinas campus on the same page.

Is this Hospital São Lucas da PUCRS?

No. PUCRS São Lucas is Porto Alegre. This page is Campinas. City is the filter.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANVISA authorization.

Did bioaccess® run NCT03899259?

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

Next step

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

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 Instituto de Oftalmología Conde de Valenciana as a bioaccess® client.

If you searched Conde de Valenciana first-in-human, Instituto de Oftalmología Fundación Conde de Valenciana clinical trial, GORE synthetic cornea Mexico City, Arturo Ramírez Miranda, or “go direct Instituto de Oftalmología Conde de Valenciana,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oftalmología Conde de Valenciana in Mexico City is a real named ophthalmology institute. FAP / Fundación spellings are 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 institute is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is included because the campus is named in press coverage (1 press mention), even though its ClinicalTrials.gov count is small. Distinct from CODET Vision Institute Tijuana, UNAM Optometry Clinic, Panama Eye Centre, and The Panama Clinic. Arturo Ramírez Miranda, MD, is the press-named investigator on the Conde item, not a second facility page.

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

Device press writes the implant, the city, the institute, and the surgeon. Device registries write a smaller NCT campus string. Neither writes the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep this campus sits on a small ALL n. On the same-day press sweep it has 1 press mention. Those are different sources:

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

• Instituto de Oftalmología Conde de Valenciana (Mexico City, Mexico) — canonical NCT string: ALL interventional n=4; DEVICE n=1. Example NCT IDs: NCT04648085, NCT06159881, NCT06477081.
• FAP / Fundación spelling aliases (including Instituto de Oftalmología Fundación Conde de Valenciana) are the same campus. Same page. No second n. No combined unique-study total.
• Press mention (1): Cornea / PMC 2025 GORE synthetic cornea early-feasibility methods name Instituto de Oftalmología Fundación Conde de Valenciana as the 2024 implant site. Press-named PI: Arturo Ramírez Miranda, MD. The same item log also prints NCT06174376 in that paper. We cite the URL as press evidence. We do not add NCT06174376 into ALL n=4. We do not invent more investigators. We do not publish a separate investigator page.

The press count is 1. Counts for NCT n with press n are kept separate.

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 Conde de Valenciana first-in-human or Arturo Ramírez Miranda finds a named Mexico City institute without finding COFEPRIS, import, insurance, or 21 CFR 812.28. A methods paper is not a CRO. We will not claim bioaccess® ran the GORE synthetic cornea EFS. We will not claim Conde as a bioaccess® client.

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

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

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

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

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

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation at Conde de Valenciana is not a CODET Tijuana file and is not a Panama eye-clinic 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 committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. 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 institute

Instituto de Oftalmología Conde de Valenciana is a serious Mexico City ophthalmology resource. ALL n=4 (DEVICE n=1) plus one public methods paper is public volume, not a punchline. This is not a critique of the institute. It is separate from CODET, UNAM optometry, Panama Eye Centre, or The Panama Clinic. Do not treat Arturo Ramírez Miranda, MD, as a second facility. 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. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto de Oftalmología Conde de Valenciana directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as CODET Tijuana, UNAM optometry, Panama Eye Centre, or The Panama Clinic?

No. CODET is the Tijuana ophthalmic page. UNAM optometry has its own page. Panama Eye Centre and The Panama Clinic are Panama. This page is Instituto de Oftalmología Conde de Valenciana, Mexico City only. FAP / Fundación spellings stay here. Arturo Ramírez Miranda, MD, is cited as press-named PI on this campus, not as a second page.

Did bioaccess® run the GORE synthetic cornea EFS?

No. The Cornea / PMC 2025 methods paper names the institute as the 2024 implant site. No public bioaccess® case-study page names this program. We will not invent that claim.

Is Arturo Ramírez Miranda a second campus?

No. He is the press-named PI on the Conde item. We do not invent more investigators. We do not publish a PI-person-as-facility page.

Should I add NCT06174376 into ALL n=4?

No. ALL n=4 is the ClinicalTrials.gov facility-string count. NCT06174376 is cited because the press item prints it. That is press citation, not a combined count.

Is Fundación / FAP Conde a different campus?

No. Same Mexico City campus. Same page. No second n. No combined total. Not CODET Tijuana.

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. Tijuana sibling (do not merge): CODET Vision Tijuana FIH.

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 de Investigaciones Clínicas del Litoral as a bioaccess® client.

If you searched Centro de Investigaciones Clinicas del Litoral first-in-human, CIC Litoral Santa Fe clinical trial, Santa Fe Argentina CRO, or “go direct Centro de Investigaciones Clínicas del Litoral,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Clínicas del Litoral in Santa Fe city, Argentina, is a real named research-clinic string on ClinicalTrials.gov. This page is Santa Fe city, Argentina — not Rosario, and not Itajaí, Brazil. 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 Santa Fe city named research clinic. Distinct from Rosario campuses: Hospital Provincial del Centenario, INECO Neurociencias Oroño, and Fundación Estudios Clínicos (separate page). It is not Clínica de Neoplasias Litoral in Itajaí, Brazil (a different country and a different NCT string). Sharing “Litoral” 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.

• Centro de Investigaciones Clinicas del Litoral (Santa Fe, Argentina) — canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT00389779, NCT00900146, NCT03547583.

We will not invent a DEVICE n. DEVICE n=0 on the ranking table; we will not pad it.

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

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

That is the leak: a founder searching “Centro de Investigaciones Clínicas del Litoral Santa Fe clinical trial” finds ALL n=27 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Centenario Rosario, INECO, Estudios Clínicos, or an Itajaí oncology clinic. A named Santa Fe city clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Santa Fe city is not a Rosario file and is not a Brazilian Litoral 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 clinic

Centro de Investigaciones Clínicas del Litoral is a serious named Santa Fe city research clinic on the public registry. ALL n=27 is registry volume, not a punchline. It is separate from Rosario Centenario, INECO, or Estudios Clínicos. Do not confuse it with Clínica de Neoplasias Litoral in Itajaí, Brazil. 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. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Centro de Investigaciones Clínicas del Litoral 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 Centenario Rosario, INECO, Fundación Estudios Clínicos, or Clínica de Neoplasias Litoral Itajaí?

No. Centenario has its own page (Rosario). INECO has its own page (Rosario). Fundación Estudios Clínicos is a Rosario page. Clínica de Neoplasias Litoral is Itajaí, Brazil — not this page and not this country. This page is Centro de Investigaciones Clínicas del Litoral, Santa Fe city, Argentina only.

Is Santa Fe city the same as Rosario for this string?

No. Rosario campuses (Centenario, INECO, Estudios Clínicos) stay on their own pages. This NCT string is Santa Fe city, Argentina.

Is this Clínica de Neoplasias Litoral in Itajaí?

No. That is Brazil. This page is an Argentine research clinic. Sharing “Litoral” is not a merge.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=27 is still not ANMAT authorization.

Did bioaccess® run NCT00389779?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Argentina. 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 ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital San Roque Córdoba as a bioaccess® client.

If you searched Hospital San Roque Cordoba first-in-human, Hospital San Roque Córdoba clinical trial, San Roque CRO Argentina, or “go direct Hospital San Roque Córdoba,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San Roque in Córdoba, Argentina, is a real named hospital on ClinicalTrials.gov. This page is Córdoba city only. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This is the Córdoba-city hospital page. Distinct from Sanatorio Allende and from Instituto Médico Río Cuarto (separate page — a different city). It is not Centro Medico San Roque Tucumán (a different city and a different NCT string). Sharing “San Roque” in the name is not a license to collapse them.

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

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

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

• Hospital San Roque (Córdoba, Argentina) — canonical NCT string: ALL interventional n=27; DEVICE n=1. Example NCT IDs: NCT00330369, NCT00634049, NCT00699972.

We will not invent extra n for Tucumán.

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

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

That is the leak: a founder searching “Hospital San Roque Córdoba clinical trial” finds ALL n=27 (DEVICE n=1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Allende, Río Cuarto, or Centro Medico San Roque Tucumán. A named Córdoba hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the hospital

Hospital San Roque in Córdoba is a serious named hospital on the public registry. ALL n=27 (DEVICE n=1) is registry volume, not a punchline. It is separate from Allende, Río Cuarto, or Centro Medico San Roque Tucumán. 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. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital San Roque Córdoba directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Sanatorio Allende, Instituto Médico Río Cuarto, or Centro Medico San Roque Tucumán?

No. Allende has its own page (a different Córdoba-city campus). Instituto Médico Río Cuarto is a different city. Centro Medico San Roque Tucumán is a different city. This page is Hospital San Roque, Córdoba only.

Is this Centro Medico San Roque in Tucumán?

No. That is a different named facility in a different city. This page is Hospital San Roque, Córdoba. The strings are kept separate even though both contain “San Roque.”

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

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

Is this the same Córdoba campus as Sanatorio Allende?

No. Allende has its own page. Sharing Córdoba city is not a merge.

Did bioaccess® run NCT00330369?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®