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Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current 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 Médicas Mar del Plata as a bioaccess® client.

If you searched Centro de Investigaciones Medicas Mar del Plata first-in-human, CIM Mar del Plata clinical trial, Mar del Plata CRO Argentina, or “go direct Centro de Investigaciones Médicas Mar del Plata,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigaciones Medicas Mar del Plata in Mar del Plata, Argentina, is a real named medical-research-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Mar del Plata medical-research center. It is not Centro de Investigaciones Médicas Tucumán, not CIPREC, and not CINME. Sharing “investigaciones médicas” in another Argentine city is not a license to collapse them. Instituto de Investigaciones Clínicas Mar del Plata is a different organization (different NCT string family; not this page). It does not have a second page here.

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 Medicas Mar del Plata (Mar del Plata, Argentina) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT01885078, NCT02620046, NCT02760407.
• Alias Centro de Investigaciones Medicas Mar Del Plata (capital D in Del): ALL n=21. Listed separately. Same page. We do not invent a combined unique-study total of 25+21. We do not ship a second page.
• Accented alias Centro de Investigaciones Médicas Mar del Plata: ALL n=20. Listed separately. Same page. No combined total.

Alias counts are listed separately. The 25+21+20 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 “CIM Mar del Plata clinical trial” or “Centro de Investigaciones Médicas Mar del Plata FIH” finds canonical ALL n=25 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIM Tucumán, CIPREC, CINME, or the Instituto de Investigaciones Clínicas Mar del Plata string. 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:

• 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 Mar del Plata is not a Tucumán CIM file and is not a Buenos Aires CIPREC or CINME 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 center

Centro de Investigaciones Medicas Mar del Plata is a serious named research center on the public registry. ALL n=25 is registry volume, not a punchline. It is separate from CIM Tucumán, CIPREC, CINME, or Instituto de Investigaciones Clínicas Mar del Plata. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Centro de Investigaciones Médicas Mar del Plata 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 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 center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as CIM Tucumán, CIPREC, CINME, or Instituto de Investigaciones Clínicas Mar del Plata?

No. CIM Tucumán has its own page. CIPREC has its own page. CINME has its own page. Instituto de Investigaciones Clínicas Mar del Plata is a different organization, not this page. This page is Centro de Investigaciones Medicas Mar del Plata only. Alias ALL n=21 and accented ALL n=20 stay listed separately; we do not combine them.

Should I add canonical ALL n=25, alias ALL n=21, and accented ALL n=20?

No. Alias n is listed separately. A combined unique-study total is not published. Capital-D “Mar Del Plata” and the accented spelling stay on this page.

Is Instituto de Investigaciones Clínicas Mar del Plata this campus?

No. That is a different organization with a different NCT string. It is not covered on this page. Sharing Mar del Plata 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=25 is still not ANMAT authorization.

Did bioaccess® run NCT01885078?

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. Argentina siblings (do not merge): CIM Tucumán. Buenos Aires academic sibling: Hospital Italiano de Buenos Aires.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched FALP first-in-human, Fundacion Arturo Lopez Perez clinical trial, Fundación Arturo López Pérez Santiago CRO, or “go direct FALP,” you followed a campus string ClinicalTrials.gov still publishes. Fundacion Arturo Lopez Perez (FALP) in Santiago, Chile, 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 ISP file.

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

This page is the named Santiago FALP campus. Distinct from Hospital Clínico Universidad Católica, Hospital Clínico Universidad de Chile, Universidad Andrés Bello, and Club de Leones Cruz del Sur. Sharing Santiago or sharing Chile is not a license to collapse them. Punta Arenas is not this 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.

• Fundacion Arturo Lopez Perez (Santiago, Chile) — ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00022516, NCT00045032, NCT00094653.
• Checked against the 1 September 2026 ClinicalTrials.gov pull on the named campus string: unique NCT IDs n=30. Same campus. Not two centers.
• Alias Fundación Arturo López Pérez: ALL n=11. Listed separately. Same page. No combined total.
• Alias FALP: ALL n=7. Listed separately. Same page. No combined total.

These counts are not added together. DEVICE n=0; we will not pad it. We will not invent PAHO/WHO Level 4 standing for ISP.

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 “FALP Santiago clinical trial” or “Fundacion Arturo Lopez Perez FIH” finds ALL n=25 (named-string n=30) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, or Club de Leones. A named Santiago 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at FALP is not a Católica, UChile, UNAB, or Punta Arenas 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 ISP actually works (the short version)

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

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

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

Not a critique of the center

Fundacion Arturo Lopez Perez is a serious named Santiago cancer center on the public registry. ALL n=25 is registry volume, not a punchline. named-string n=30 is the same named string, not a second campus. We do not invent a DEVICE n. We do not invent PAHO/WHO Level 4 for ISP. It is separate from Católica, UChile, UNAB, or Club de Leones. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract FALP 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 ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this 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 Clínico Universidad Católica, Hospital Clínico Universidad de Chile, Universidad Andrés Bello, or Club de Leones Cruz del Sur?

No. Católica has its own page. UChile has its own page. UNAB has its own page. Club de Leones has its own page (Punta Arenas). This page is Fundacion Arturo Lopez Perez / FALP, Santiago only. ALL n=25 is ranking; named-string n=30 is the named string; alias n=11 and n=7 stay listed separately. We do not combine.

Should I add ALL n=25, named-string n=30, alias n=11, and FALP n=7?

No. ALL n=25 is the ranking row. named-string n=30 is the same named string confirmed. Alias n is listed separately. A combined unique-study total is not published.

Is FALP a Santiago university hospital?

No. Católica, UChile, and UNAB remain on their own pages. This page is Fundacion Arturo Lopez Perez.

Does ISP have PAHO/WHO Level 4 standing?

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

Did bioaccess® run NCT00022516?

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 Chile. Santiago sibling (do not merge): Hospital Clínico Universidad de Chile.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Nacional Cayetano Heredia first-in-human, Cayetano Heredia Lima clinical trial, HNCH CRO Peru, or “go direct Hospital Nacional Cayetano Heredia,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Nacional Cayetano Heredia in Lima, Peru, is a real named national-hospital string on ClinicalTrials.gov. It is not Universidad Peruana Cayetano Heredia. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

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

This page is the named Lima hospital. Distinct from INEN Lima. It is also not Universidad Peruana Cayetano Heredia (university string ALL n=23 — not this hospital). Sharing “Cayetano Heredia” is not a merge. We do not invent a Peruvian legal entity on this page.

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

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), 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 Nacional Cayetano Heredia (Lima, Peru) — ranking row: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00352716, NCT00441285, NCT00612898.
• Checked against the 1 September 2026 ClinicalTrials.gov pull on the same named hospital string: unique NCT IDs n=34. Do not treat 25 and 34 as two campuses.
• This page is separate from Universidad Peruana Cayetano Heredia (ALL n=23). That is a university string, not this hospital page. Listed separately so a founder searching the university still does not land here as one combined entry.

These counts are not added together. The university n=23 is not added. 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 hospital as a client site.

That is the leak: a founder searching “Hospital Nacional Cayetano Heredia clinical trial” or “Cayetano Heredia Lima FIH” finds ALL n=25 (named-string n=34) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28 — and without landing on INEN. A named Lima hospital is still a site. An NCT location row is not a CRO. We do not invent a Peruvian legal entity.

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

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

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

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

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

• INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page. We do not invent a Peruvian legal entity. A hallway conversation at Hospital Nacional Cayetano Heredia is not an INEN file and is not a university-string 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 INS actually works (the short version)

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

Ask for a protocol-specific calendar. A hospital email is not INS 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 Nacional Cayetano Heredia is a serious named Lima hospital on the public registry. ALL n=25 is registry volume, not a punchline. named-string n=34 is the same named hospital string, not a second campus. It is separate from INEN or into Universidad Peruana Cayetano Heredia. We do not invent a DEVICE n. 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 INS / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Nacional Cayetano Heredia directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as INEN Lima or Universidad Peruana Cayetano Heredia?

No. INEN has its own page. Universidad Peruana Cayetano Heredia is a university NCT string (ALL n=23), not this hospital. This page is Hospital Nacional Cayetano Heredia only. ALL n=25 is ranking; named-string n=34 is the same named hospital string. We do not combine with the university.

Should I add ALL n=25 and named-string n=34?

No. ALL n=25 is the ranking row. named-string n=34 is the same named hospital string confirmed. They are not two campuses.

Is Universidad Peruana Cayetano Heredia this hospital?

No. That is a university string (ALL n=23). This page is the hospital. We do not merge them. INEN has its own page, a different Lima string.

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

No. It is a published statutory target on the Peru hub in the drug-trial framework; 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. Ask for a protocol-specific calendar.

Did bioaccess® run NCT00352716?

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 Peru.

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 Felício Rocho as a bioaccess® client.

If you searched Hospital Felicio Rocho first-in-human, Hospital Felício Rocho Belo Horizonte clinical trial, Felício Rocho CRO, or “go direct Hospital Felício Rocho,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Felicio Rocho in Belo Horizonte, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Belo Horizonte hospital. Distinct from Santa Casa de Belo Horizonte and from Universidade Federal de Minas Gerais. Sharing Belo Horizonte 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 Felicio Rocho (Belo Horizonte, Brazil) — ranking / canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT00094302, NCT00413218, NCT00634049. Checked against the 1 September 2026 ClinicalTrials.gov pull: unique NCT IDs n=25 on this Belo Horizonte string.
• Accented alias Hospital Felício Rocho: ALL n=17. Listed separately. Same page. We do not invent a combined unique-study total of 25+17. We do not ship a second page for the accented 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 Felício Rocho clinical trial” or the unaccented spelling finds ALL n=25 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Santa Casa BH or UFMG. A named Belo Horizonte 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 at Felício Rocho is not a Santa Casa BH file and is not a UFMG university-string 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 Felicio Rocho is a serious named Belo Horizonte hospital on the public registry. ALL n=25 is registry volume, not a punchline. We do not invent a DEVICE n. It is separate from Santa Casa BH or UFMG. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Felício Rocho 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 Santa Casa de Belo Horizonte or Universidade Federal de Minas Gerais?

No. Santa Casa BH has its own page. UFMG has its own page. This page is Hospital Felicio Rocho, Belo Horizonte only. Accented ALL n=17 stays listed separately; we do not combine them.

Should I add ALL n=25 and the accented ALL n=17?

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

Is this Santa Casa BH or UFMG?

No. Santa Casa de Belo Horizonte has its own page. UFMG has its own page (university string). This page is Hospital Felicio Rocho only.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=25 is still not ANVISA authorization.

Did bioaccess® run NCT00094302?

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. Belo Horizonte sibling (do not merge): Santa Casa de Belo Horizonte.

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 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital 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 typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation on this campus is not that file. A hallway conversation 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 typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

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

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

Not a critique of the 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital 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 typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. Registro sanitario (~30 working days) is a different file.

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

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

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

Not a critique of the clinic

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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract 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 typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. Registro sanitario (~30 working days) is a different file.

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

No. 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto de 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®