Category: Advantages of Conducting Trials in Latin America

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 Federal University of São Carlos as a bioaccess® client.

If you searched Federal University of Sao Carlos first-in-human, UFSCar clinical trial, Universidade Federal de Sao Carlos CRO, or “go direct Federal University of São Carlos,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of São Carlos (UFSCar) in São Carlos, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named São Carlos UFSCar campus. It is not Beneficência Portuguesa São Paulo (already published), not Faculdade de Medicina do ABC, and not Federal University of Santa Maria. Sharing a Federal University name is not a license to collapse them. UFSCar is not Beneficência Portuguesa. UFSCar is not ABC.

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.

• Federal University of São Carlos (São Carlos, Brazil) — canonical NCT string: ALL interventional n=43; DEVICE n=13. Example NCT IDs: NCT01090271, NCT01106755, NCT01770938.

Example device NCT IDs are the first 3 of the device list.

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

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

That is the leak: a founder searching Federal University of São Carlos first-in-human finds ALL n=43 (DEVICE n=13) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFSCar is not a Beneficência Portuguesa 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

Federal University of São Carlos is a serious named Brazilian campus on the public registry. ALL n=43 and DEVICE n=13 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Federal University of São Carlos directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Beneficência Portuguesa São Paulo?

No. Beneficência Portuguesa São Paulo is already published. This page is Federal University of São Carlos only.

Did bioaccess® run NCT01090271?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Not a critique of the hospital

FLENI is a serious named Buenos Aires campus on the public registry. ALL n=52 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

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

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

Did bioaccess® run the NCT IDs listed here?

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

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

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

Did bioaccess® run NCT07475611?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. CABA sibling (do not merge): Psoriahue.

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the hospital

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

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

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

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

Colombia is still on the map

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

Frequently asked questions

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

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

Did bioaccess® run the NCT IDs listed here?

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

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

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

Did bioaccess® run NCT04766554?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Mexico sibling (do not merge): Instituto Nacional de Cardiología Ignacio Chávez.

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the hospital

Unicamp is a serious named Campinas campus on the public registry. ALL n=147 and DEVICE n=2 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Unicamp Campinas directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

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

Did bioaccess® run NCT04171063?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Campinas sibling (do not merge): Hospital Celso Pierro Campinas.

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the hospital

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

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital de Base São José do Rio Preto directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

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

Did bioaccess® run NCT04701684?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Brasília sibling (do not merge): Hospital de Base Distrito Federal Brasília.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from the PR Newswire release “Nanochon Performs First Case in the Chondrograft™ First in Human Clinical Study” (2 September 2026, 16:58 ET), the live ClinicalTrials.gov record NCT07542184 (last update posted 21 August 2026; first posted 21 April 2026), and published bioaccess® Panama pages, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the investigators, facility, and trial those sources support, and we do not reprint site contact emails or phone numbers. Nanochon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT and did not run this study.

If you searched Dr. Juan Osorio Panamá, Juan Osorio principal investigator Chondrograft, Emilio Tufiño knee cartilage trial, Nanochon first case Panamá, or “go direct to the surgeon,” you followed an investigator string that public press and ClinicalTrials.gov both publish. Dr. Juan Osorio is a real named principal investigator. He is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the investigator is the investigator and the hospital is the site. The First-in-Human CRO still owns MINSA / CNBI, 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 Panamá is not the only fit. Sponsors who skip the CRO and email the surgeon still have to rebuild that stack. A principal-investigator line does not become a CRO.

This is a person-string page, and it exists only because the building already has its own page. The facility page stays at The Panama Clinic (Spanish: versión en español), and the distinct legal-entity string stays at CEVAXIN / The Panama Clinic. This page does not repeat clinical trials in Panama. That page stays the country operating system.

Why the surgeon’s name wins the search — and why that is not a CRO

On 2 September 2026, Nanochon announced the successful treatment of the first patient in its First-in-Human study of Chondrograft™, a 3D-printed implant for articular cartilage defects of the knee. Per that release: Dr. Juan Osorio and Dr. Emilio Tufiño, both specialists in regenerative sports medicine, performed the first procedure at The Panama Clinic, Panamá. Dr. Osorio is quoted in the release identifying himself as the Principal Investigator for the study. Dr. Tufiño is quoted describing the procedure as “bone-sparing, minimally invasive, and streamlined.” The release also states that Nanochon plans a Level 1 multi-center, randomized, controlled pivotal trial after the FIH study, and that Chondrograft™ has FDA Breakthrough Device Designation. No CRO is named anywhere in that release.

The registry says the same thing in registry language. NCT07542184 — brief title: Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) – Panama. Official title: A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions. Organization study ID: 101-2024 – PAN. Lead sponsor: Nanochon, Inc., class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

Design on the 3 September 2026 snapshot: interventional; single-group; no masking; primary purpose treatment; phase N/A; estimated enrollment 5. Actual start 30 July 2026; estimated primary completion and completion September 2027. Study first posted 21 April 2026; last update posted 21 August 2026 — that is, before the 2 September first-case announcement. Status RECRUITING. Condition: knee cartilage lesions, with registry keywords for medial and lateral femoral condyle and trochlear articular cartilage lesions. Intervention: a device — mini-arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft. Eligibility: male or female aged 22–60, MRI knee evaluation within six months, able to read and speak English and/or Spanish, and voluntary signature of the REB-approved informed consent.

The single Panama location row is The Panama Clinic, Panama City, Provincia de Panamá, RECRUITING, with Juan Osorio, MD listed as PRINCIPAL_INVESTIGATOR. That is the registry’s own field, not our inference. A sister Canadian record, NCT07249489 (same official title, org study ID 101-2024-CAN, estimated n=10, NOT_YET_RECRUITING, last update posted 2 September 2026), lists University of British Columbia in Vancouver and an Orthopaedic Clinic in Toronto. Canada is outside the Latin American geography this page covers; we note it so nobody merges the two records.

Read the two sources together. An estimated five patients, a 3D-printed implant, a Breakthrough-designated device, a planned pivotal RCT to follow — and the only human names a sponsor can find are two surgeons and a company CEO. That is the search gap in its purest form: the search resolves to a person, and the person is not the operator of the file.

The investigator is the investigator. The CRO is the operator.

A regenerative sports-medicine surgeon in Panama City can carry the procedure, the surgical judgement, the follow-up exams, and the source documents. That is necessary, and on this program it is clearly working — the first case was enrolled and treated quickly enough that the sponsor made a point of it. It is still not the same job as owning a first-in-human file.

What a named investigator and their hospital can typically do when a sponsor “goes direct”:

• Discuss investigator interest and surgical feasibility for a cartilage protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, theatre, and local staffing costs for the cases they will physically perform.

What an investigator is not built to own for an investigational device:

• MINSA and the CNBI. The national file and the national bioethics pathway are not a hallway conversation with a surgeon.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit, end to end. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The published bioaccess® Panama planning band is $5,000–$15,000 depending on device risk and enrollment. That is a published planning band, not a quote for this study.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF — across Panamá and any second country.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. A five-patient EFS that is meant to feed a Level 1 pivotal trial is exactly when one surgeon’s calendar stops being the plan.

Going direct to Dr. Osorio is how you confirm a surgeon. It is not how you open an investigational file.

Investigator versus CRO

Workstream	What the named investigator and hospital typically own	What the CRO still owns
Procedure	Mini-arthrotomy or arthroscopic implantation, imaging, follow-up exams	Protocol fit, training, implant accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by being named as PI	MINSA / CNBI file
Import	Receiving and storage if contracted	Importer of record for the investigational implant
Quality	Source documents from the cases performed	ISO 14155 monitoring, EDC, AE reporting, TMF
FDA conversation	Clinical judgement and case data	21 CFR 812.28 narrative — eligibility, not clearance
Scale-up	One surgical team in Panama City	Second country, pivotal readiness, Colombia (INVIMA) and the rest of the platform

What the Nanochon public file actually supports — and what it does not

• Device: Chondrograft™, a 3D-printed implant for focal articular cartilage defects of the knee, with FDA Breakthrough Device Designation per the company release.
• Sponsor: Nanochon, Inc. (industry). No collaborator on the NCT. No CRO named in the release or on the record.
• Site: The Panama Clinic, Panama City — the only Panama location row, RECRUITING. Already covered on its own page.
• Named investigators (as published): Juan Osorio, MD — principal investigator on the NCT row and self-identified as PI in the 2 September release; Emilio Tufiño, MD — named in the release as performing the first procedure. We do not merge them into a single identity and we do not add a third name.
• Milestone: first patient treated, announced 2 September 2026. Actual study start on the registry is 30 July 2026.
• Not claimed here: that bioaccess® ran this study or is on this NCT; that Nanochon is a bioaccess® client; that we have Chondrograft outcomes; that Breakthrough Device Designation is clearance or approval; that the Panama and Canada records are one study.

What the CRO still does after you have a surgeon’s name

• Regulatory-fit, not tourism. Panamá is a lead first-in-human jurisdiction on the published platform. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the MINSA / CNBI packet.
• Importer of record and implant accountability.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for the FDA conversation that a Breakthrough-designated implant will eventually need.
• Optionality when a five-patient EFS has to become a multi-centre pivotal study.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background: LATAM FIH hospitals vs the CRO.

Frequently asked questions

Why is there a page for a person rather than only for the hospital?

Because sponsors search the string they see, and the 2 September release put two surgeons’ names in front of the building. The facility page already exists at The Panama Clinic, and the legal-entity page exists at CEVAXIN. This page answers the investigator query and links back rather than duplicating either one.

Can I contract Dr. Osorio directly?

You can try. A principal investigator can discuss surgical feasibility, institutional ethics calendars, and local case costs. He cannot become your MINSA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because a press release named him. Contract the CRO; let the CRO activate the site and the investigator.

Did bioaccess® run the Chondrograft first-in-human study?

No. No public bioaccess® page says so, bioaccess® is not on NCT07542184, and we will not invent that relationship. This page answers the search; it does not claim the study.

Does Breakthrough Device Designation mean the implant is approved?

No. The company release states the designation; a designation is a review-interaction pathway, not clearance or approval. A first-in-human EFS is still an investigational study, and foreign data still has to meet 21 CFR 812.28 conditions to be eligible for FDA submission and review.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Panamá investigator search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT06152341 (last update posted 31 August 2026; first posted 30 November 2023) and the published bioaccess® Dominican Republic country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Akura Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Centro de Intervenciones Cardiovasculares clinical trial, CIC Santiago de los Caballeros, Akura Medical ATC System, pulmonary embolism thrombectomy Dominican Republic, or “go direct to the Santiago site,” you followed a facility string ClinicalTrials.gov still publishes on 31 August 2026. Centro de Intervenciones Cardiovasculares in Santiago de los Caballeros, Santiago Province, is a real named cardiovascular facility on that record. It is not the operator of the DIGEMAPS file.

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

This page is for the Santiago de los Caballeros query. It does not repeat clinical trials in the Dominican Republic. That page stays the country operating system. Sister Dominican pages stay on their own buildings: Laser Center Santo Domingo, Instituto Espaillat Cabral, and Clínica Canela La Romana. Santiago de los Caballeros is a different city from Santo Domingo and from La Romana. The pages are separate. The two São Paulo rows on the same NCT already have their own pages: Instituto Dante Pazzanese and InCor HCFMUSP.

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

NCT06152341 is an industry device listing. Brief title: Safety and Effectiveness of the ATC System in the Treatment of Acute PE. Official title: Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism. Organization study ID: CP-60003. Lead sponsor: Akura Medical, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The record publishes no central contact and no overall official.

Design on the 3 September 2026 snapshot: interventional; prospective, single-arm, multicenter; no masking; primary purpose treatment; phase N/A; estimated enrollment 30. Actual start 15 May 2024; estimated primary completion April 2027; estimated completion May 2027. Study first posted 30 November 2023; last update posted 31 August 2026. Condition: acute pulmonary embolism.

Status on that snapshot is SUSPENDED. The registry’s own reason, quoted as published: enrollment is temporarily paused pending device resupply to sites; enrollment is expected to resume to reach the target sample size following a recently approved protocol amendment; and the pause is not related to subject safety or device performance. We report that as written and add nothing to it.

Intervention, in the registry’s words: a device — the ATC System, designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. An unapproved, exported thrombectomy system running at 30 patients across three Latin American buildings is a CRO file, not a hospital favour.

The three location rows currently published:

• Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil — already published.
• Instituto do Coracao (InCor), São Paulo, Brazil — already published.
• Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros, Santiago Province, Dominican Republic — this page. No principal investigator, contact, or row-level status is published for it.

Read the record as it is. Two Brazilian cardiology institutes had public pages and the Dominican row did not, even though it is the only Caribbean building on an unapproved-device PE study. That is the search gap: a sponsor searching Akura, ATC System, or Santiago de los Caballeros interventional cardiology lands on a named hospital with no operator in the public copy.

Santiago de los Caballeros is a site. The CRO is the operator.

A Dominican interventional-cardiology centre can provide cath-lab time, a PE response pathway, imaging, and operators who do pulmonary-artery work. That is necessary. It is not sufficient for an unapproved, U.S.-exported thrombectomy system a sponsor expects to defend to a U.S. board later.

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

• Discuss investigator interest and procedural feasibility for a PE protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional Research Ethics Committee calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

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

• DIGEMAPS. The Ministry of Public Health, through the Dirección General de Medicamentos, Alimentos y Productos Sanitarios, is the national authority for health products including medical devices. A cath-lab conversation is not that submission.
• CONABIOS-overseen ethics. The Consejo Nacional de Bioética en Salud oversees Research Ethics Committees; institutional REC review is tied to the host institution once the site is chosen.
• Investigational import. A separate permit from the trial authorization and from a later commercial DIGEMAPS registration. The live importer-of-record guide already records DIGEMAPS as created by Decreto 82-15 (2015), with registration and import rules in Decreto 246-06. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Santiago-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including across the two São Paulo rows on the same NCT.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. A suspended-for-resupply study is precisely when a single-hospital MSA stops stretching.

Going direct to Centro de Intervenciones Cardiovasculares is how you confirm a cath lab. It is not how you open an investigational file.

Site versus CRO

Workstream	What the Santiago centre (site) typically owns	What the CRO still owns
Procedure	Cath lab, PE pathway, imaging, local staff	Protocol fit, training, device accountability and resupply logistics
Ethics	Institutional REC calendar and local rules	Packet, ICF, IB alignment, deficiency cycle under CONABIOS oversight
National authority	Not the permit holder by being listed on an NCT	DIGEMAPS clinical-trial file
Import	Receiving and storage if contracted	Importer of record for an unapproved, U.S.-exported system
Quality	Hospital quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Santiago building (plus two São Paulo rows on the same NCT)	Colombia (INVIMA), Panama, and the rest of the bioaccess® platform

How DIGEMAPS and CONABIOS sit next to the hospital

Use clinical trials in the Dominican Republic for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:

• Institutional REC review averages ~30 days; CONABIOS-level review averages ~45 days, up to 120 depending on complexity.
• DIGEMAPS is the national regulatory authority for health products including medical devices; CONABIOS oversees Research Ethics Committees.
• Protocols follow the Declaration of Helsinki and the CIOMS international ethical guidelines. The submission package is in Spanish.
• The country hub publishes ~30% lower program cost than a comparable U.S. program — an experience-based estimate from work since 2010, not a formal study.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not clearance or approval.
• A commercial DIGEMAPS registration is a second, separate file from a clinical-trial authorization.

We will not invent a Santiago-only day count. Ask for a protocol-specific calendar. A hospital email is not a DIGEMAPS authorization.

What the Akura public file actually supports — and what it does not

• Device: the ATC System for mechanical removal of emboli in acute pulmonary embolism, as described on NCT06152341.
• Sponsor: Akura Medical (industry). No collaborator. No CRO named.
• Sites: Instituto Dante Pazzanese and Instituto do Coracao, São Paulo (existing pages); Centro de Intervenciones Cardiovasculares, Santiago de los Caballeros (this page).
• Design: prospective single-arm multicenter, phase N/A, estimated n=30, actual start 15 May 2024.
• Status: SUSPENDED — enrollment paused pending device resupply, expected to resume after an approved protocol amendment; the registry states the pause is not related to subject safety or device performance.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Akura Medical is a bioaccess® client; that we have ATC outcomes; that a named investigator exists on this row when the registry prints none; that Santiago de los Caballeros is the same building as Santo Domingo or La Romana.

What the CRO still does after you have a hospital name

• Regulatory-fit, not tourism. The Dominican Republic is a lead first-in-human jurisdiction on the published platform. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet — in Spanish.
• Importer of record and device accountability, including resupply across activated rows.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality when one Caribbean cath lab is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background: ClinicalTrials.gov FIH sites vs the CRO.

Frequently asked questions

Can I contract Centro de Intervenciones Cardiovasculares directly?

You can try. The facility can discuss investigator interest, local procedure costs, and REC calendars. It cannot become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Akura listed Santiago on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Akura ATC study?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

The study is SUSPENDED. Is that a safety problem?

The registry says no. Its stated reason is a temporary enrollment pause pending device resupply to sites, with enrollment expected to resume after an approved protocol amendment, and it explicitly states the pause is not related to subject safety or device performance. We quote that; we do not reinterpret it. Resupply across three countries is, however, exactly the import-and-accountability workstream a site does not own.

Who is the principal investigator in Santiago de los Caballeros?

The registry does not name one on this location row, and neither will we.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Dominican search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Centro de Retina Médica y Quirúrgica clinical trial, Zapopan Jalisco IOL study, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Zapopan site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Centro de Retina Medica y Quirurgica SC is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Centro de Retina Medica y Quirurgica SC 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 Zapopan is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row does not become a CRO.

This page is for the Zapopan query. It does not repeat clinical trials in Mexico. That page stays the country operating system. The two Mexico City rows on this same NCT get their own pages: Asociación Para Evitar la Ceguera en México and Salauno Salud. This page is the Zapopan retina campus string (ZIP 45116, Jalisco) only. It is not any other Jalisco research centre already on this site.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already published at Clinica 20/20.
• Laser Center SA, Santo Domingo, Dominican Republic — already published at Laser Center Santo Domingo.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already published at Panama Eye Centre / Orillac-Calvo MINIject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until now none of the three had a dedicated public page. That is the search gap: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Zapopan is a site. The CRO is the operator.

Centro de Retina Medica y Quirurgica SC can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Centro de Retina Medica y Quirurgica SC is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

Workstream	What the Zapopan retina centre (site) typically owns	What the CRO still owns
Procedure	OR list, phacoemulsification, biometry, refractive follow-up, local staff	Protocol fit, surgeon training, investigational IOL accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
National authority	Not the permit holder by being listed on an NCT	COFEPRIS clinical-investigation file, in Spanish
Import	Receiving and storage if contracted	Importer of record for an unapproved, U.S.-exported lens
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, AE reporting, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One building on a six-site record	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS and ethics sit next to the clinic

Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

• Ethics committee review under NOM-012-SSA3-2012 comes first, then COFEPRIS review; the calendar is confirmed per protocol.
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

What the Alcon public file actually supports — and what it does not

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Centro de Retina Medica y Quirurgica SC — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling page.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Centro de Retina Medica y Quirurgica SC directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Salauno clinical trial, Salauno Salud SAPI de CV Mexico City, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Mexico City site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Salauno Salud SAPI de CV is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Salauno Salud SAPI de CV 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 Mexico City is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row does not become a CRO.

This page is for the Mexico City query. It does not repeat clinical trials in Mexico. That page stays the country operating system. The two other Mexican rows on this same NCT get their own pages: Asociación Para Evitar la Ceguera en México and Centro de Retina Médica y Quirúrgica Zapopan. This page is the Salauno legal-entity string only. Salauno is a separate organisation from APEC and from Conde de Valenciana.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already published at Clinica 20/20.
• Laser Center SA, Santo Domingo, Dominican Republic — already published at Laser Center Santo Domingo.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already published at Panama Eye Centre / Orillac-Calvo MINIject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this set none of the three had a dedicated public page. That is the search gap: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Mexico City is a site. The CRO is the operator.

Salauno Salud SAPI de CV can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Salauno Salud SAPI de CV is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

Workstream	What Salauno (site) typically owns	What the CRO still owns
Procedure	OR list, phacoemulsification, biometry, refractive follow-up, local staff	Protocol fit, surgeon training, investigational IOL accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
National authority	Not the permit holder by being listed on an NCT	COFEPRIS clinical-investigation file, in Spanish
Import	Receiving and storage if contracted	Importer of record for an unapproved, U.S.-exported lens
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, AE reporting, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One building on a six-site record	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS and ethics sit next to the clinic

Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

• Ethics committee review under NOM-012-SSA3-2012 comes first, then COFEPRIS review; the calendar is confirmed per protocol.
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

What the Alcon public file actually supports — and what it does not

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Salauno Salud SAPI de CV — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling page.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Salauno Salud SAPI de CV directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Asociación Para Evitar la Ceguera en México clinical trial, APEC Mexico City IOL study, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Mexico City site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Asociación Para Evitar la Ceguera en México is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Asociación Para Evitar la Ceguera en México 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 Mexico City is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row does not become a CRO.

This page is for the Mexico City query. It does not repeat clinical trials in Mexico. That page stays the country operating system. Sibling Mexico City pages stay on their own buildings: Instituto de Oftalmología Conde de Valenciana. The two other Mexican rows on this same NCT get their own pages: Salauno Salud and Centro de Retina Médica y Quirúrgica Zapopan. This page is the APEC campus string only. It is not CODET Vision Institute Tijuana and it is not Conde de Valenciana.

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

NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.

Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.

Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.

The six location rows currently published:

• Clinica 20/20, San José, Costa Rica — already published at Clinica 20/20.
• Laser Center SA, Santo Domingo, Dominican Republic — already published at Laser Center Santo Domingo.
• Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
• Asociación Para Evitar la Ceguera en México, Mexico City.
• Salauno Salud SAPI de CV, Mexico City.
• Panama Eye Center, Panama City — already published at Panama Eye Centre / Orillac-Calvo MINIject.

Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this set none of the three had a dedicated public page. That is the search gap: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.

Mexico City is a site. The CRO is the operator.

Asociación Para Evitar la Ceguera en México can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.

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

• Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote surgery, visit, and local staffing costs for the cases they will physically run.

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

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.

Going direct to Asociación Para Evitar la Ceguera en México is how you confirm an operating list. It is not how you open an investigational file.

Site versus CRO

Workstream	What the APEC campus (site) typically owns	What the CRO still owns
Procedure	OR list, phacoemulsification, biometry, refractive follow-up, local staff	Protocol fit, surgeon training, investigational IOL accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
National authority	Not the permit holder by being listed on an NCT	COFEPRIS clinical-investigation file, in Spanish
Import	Receiving and storage if contracted	Importer of record for an unapproved, U.S.-exported lens
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, AE reporting, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One building on a six-site record	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS and ethics sit next to the clinic

Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

• Ethics committee review under NOM-012-SSA3-2012 comes first, then COFEPRIS review; the calendar is confirmed per protocol.
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.

What the Alcon public file actually supports — and what it does not

• Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
• Sponsor: Alcon Research (industry). No collaborator. No CRO named.
• Site: Asociación Para Evitar la Ceguera en México — one of six published location rows.
• Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
• Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
• Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling page.

What the CRO still does after you have a clinic name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability across every activated row.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.

Frequently asked questions

Can I contract Asociación Para Evitar la Ceguera en México directly?

You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Alcon fluid-accommodating IOL study?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

Who is the principal investigator at this site?

The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.

The study is ACTIVE_NOT_RECRUITING. Why does this page exist?

Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.