Category: First-in-Human

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

If you searched CEDOES Vitoria first-in-human, CEDOES Vitória clinical trial, Centro de Diagnóstico e Pesquisa da Osteoporose do ES CRO, or “go direct CEDOES Vitória,” you followed a campus string ClinicalTrials.gov still publishes. CEDOES in Vitória, Espírito Santo, Brazil, is a real named research-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Vitória / Espírito Santo intercept. There is no prior Vitória CMS slug. Aliases named on the picks file — Centro de Diagnóstico e Pesquisa da Osteoporose do ES — merge onto this slug. We do not invent an expansion beyond what the picks file states. We do not invent extra n for aliases. We do not clone São Paulo, Porto Alegre, or Rio Preto campuses onto Espírito Santo.

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; complete dump), this campus sits here after filters:

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• CEDOES (Vitória, Brazil): ALL interventional n=37; DEVICE n=0 on the picks file. Batch-5 pick #3. Example NCT IDs: NCT01147289, NCT03987919, NCT04184622.

Alias on this slug only: Centro de Diagnóstico e Pesquisa da Osteoporose do ES. The picks file does not give a second n for that expansion. We will not invent one. We will not invent a unique-study union.

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

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

That is the leak: a founder searching “CEDOES Vitória clinical trial” or “osteoporosis ES research clinic FIH” finds ALL n=37 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28. Espírito Santo is still not a CRO product, and not a claim that bioaccess® ran any of those IDs.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

Use clinical-trials-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.

Do not smear the clinic

CEDOES is a serious Espírito Santo research clinic on the public registry. ALL n=37 is registry volume, not a punchline. Do not invent a second slug for the osteoporosis-center expansion. Do not invent extra n. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract CEDOES Vitória directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as a prior Vitória CMS page, or a São Paulo / Porto Alegre clone?

No. There is no prior Vitória CMS slug. This page does not clone Einstein, HCPA, Santa Casa Porto Alegre, FAMERP, or any São Paulo hospital intercept. It is CEDOES, Vitória, Espírito Santo only.

Is Centro de Diagnóstico e Pesquisa da Osteoporose do ES a different campus?

No. The picks file lists that expansion as an alias of CEDOES. One slug. We do not invent a second n.

Does ALL n=37 mean this clinic is a device CRO?

No. n is unique NCT IDs per facility string. Combined ethics + ANVISA still typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A named clinic is the site, not the operator.

Why DEVICE n=0?

That is the picks-file DEVICE count. We will not invent a DEVICE ranking from the CSV top-40 dump.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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 Santa Casa de Belo Horizonte as a bioaccess® client.

If you searched Santa Casa Belo Horizonte first-in-human, Santa Casa de Misericordia de Belo Horizonte clinical trial, Santa Casa BH CRO, or “go direct Santa Casa de Belo Horizonte,” you followed a campus string ClinicalTrials.gov still publishes. Santa Casa de Misericórdia de Belo Horizonte in Belo Horizonte, Minas Gerais, Brazil, is a real hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Belo Horizonte Santa Casa intercept. Distinct from Irmandade da Santa Casa de Misericórdia de Porto Alegre (CMS 95651). That is a different city, a different state (Rio Grande do Sul vs Minas Gerais), and a different NCT string family. Sharing the words “Santa Casa” is not a license to collapse them. This page is not a Porto Alegre clone.

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; complete dump), this campus sits here after filters:

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Santa Casa de Misericordia de Belo Horizonte (Belo Horizonte, Brazil): ALL interventional n=38; DEVICE n=0 on the picks file. Batch-5 pick #2. Example NCT IDs: NCT00071331, NCT00412893, NCT00413218.

Cite ALL n=38 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not borrow a Porto Alegre Santa Casa count onto this campus.

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 “Santa Casa Belo Horizonte clinical trial” finds ALL n=38 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Santa Casa Porto Alegre. Minas Gerais is not Rio Grande do Sul. An NCT city field is not a license to collapse every Santa Casa.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in Belo Horizonte is not a Porto Alegre Santa Casa 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-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.

Do not smear the hospital

Santa Casa de Belo Horizonte is a serious Minas Gerais resource. ALL n=38 is registry volume, not a punchline. Do not merge it into Santa Casa Porto Alegre (CMS 95651). Do not smear that campus by treating every Santa Casa string as one ANVISA file. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Santa Casa de Belo Horizonte 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 intercepts the search; it does not claim the studies.

Is this the same page as Santa Casa de Porto Alegre?

No. Irmandade da Santa Casa de Misericórdia de Porto Alegre is CMS 95651. Different city. Minas Gerais vs Rio Grande do Sul. This page is Santa Casa de Misericórdia de Belo Horizonte only.

Is Belo Horizonte the same metro as Porto Alegre?

No. Porto Alegre is Rio Grande do Sul. Belo Horizonte is Minas Gerais. Sharing a hospital-order name does not make them one CEP or one ANVISA file.

Does ALL n=38 mean this campus already owns ANVISA?

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub.

Why DEVICE n=0?

That is the picks-file DEVICE count for this string. We will not invent a DEVICE n from the CSV top-40 dump.

Next step

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

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 Liga Norte Riograndense Contra o Câncer as a bioaccess® client.

If you searched Liga Norte Riograndense Contra o Cancer first-in-human, Liga Norte Riograndense Natal clinical trial, Liga contra o câncer Natal CRO, or “go direct Liga Norte Riograndense Contra o Câncer,” you followed a campus string ClinicalTrials.gov still publishes. Liga Norte Riograndense Contra o Câncer in Natal, Rio Grande do Norte, Brazil, is a real cancer-league hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Natal cancer-league intercept. Distinct from Barretos Cancer Hospital (CMS 95648), ICESP (CMS 95642), INEN Lima (CMS 95644), INCan Mexico (CMS 95655), Hospital Erasto Gaertner (CMS 95656), and Hospital Amaral Carvalho (CMS 95652). Natal is not Barretos, not São Paulo, not Lima, not Mexico City, not Curitiba, and not Jaú. An oncology NCT string is not a license to collapse every cancer campus in Latin America.

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; complete dump), this campus sits here after filters:

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Liga Norte Riograndense Contra O Cancer (Natal, Brazil) — canonical NCT string: ALL interventional n=39; DEVICE n=1. Batch-5 pick #1. Example NCT IDs: NCT01909453, NCT02312258, NCT03268954.
• Accented duplicate string (same campus, same city): ALL n=24. That alias is named here so a founder searching the ç/â spelling still lands on this slug. We do not publish a second slug. We do not add 39+24 as a unique-study union.

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 “Liga Norte Riograndense clinical trial” or “Natal cancer hospital FIH” finds a public campus string without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho. Registry volume in Natal is still not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in Natal is not a Barretos, ICESP, or Erasto 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-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.

Do not smear the hospital

Liga Norte Riograndense Contra o Câncer is a serious Natal resource. ALL n=39 (DEVICE n=1) on the picks file is registry volume, not a punchline. The accented ALL=24 row is a spelling alias, not a second hospital and not a union we invent. Do not merge it into Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Liga Norte Riograndense Contra o Câncer 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 intercepts the search; it does not claim the studies.

Is this the same page as Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho?

No. Barretos is CMS 95648. ICESP is CMS 95642. INEN is CMS 95644 (Lima, Peru — INS, not ANVISA). INCan is CMS 95655 (Mexico City, COFEPRIS). Erasto Gaertner is CMS 95656. Amaral Carvalho is CMS 95652 (Jaú). This page is the Natal Liga Norte Riograndense campus only.

Why two ALL n values on one page?

ClinicalTrials.gov stored an unaccented canonical string (ALL n=39; DEVICE n=1) and an accented duplicate (ALL n=24). This page intercepts both as one campus. It does not add the counts.

Is n=39 plus n=24 equal to 63 unique studies?

We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a union.

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

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 1 is a registry token, not a dossier.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched UNAM Optometry Clinic first-in-human, Optometry Clinic National Autonomous University Mexico City clinical trial, UNAM optometry CRO, or “go direct UNAM Optometry Clinic,” you followed a campus string ClinicalTrials.gov still publishes. The ranking string is Optometry Clinic, National Autonomous University, Mexico City, Mexico. It is a university optometry clinic. It is the site, not the CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the UNAM optometry-clinic intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623), Instituto Nacional de Cancerología (this batch), and CODET Vision Institute Tijuana. A university clinic in Mexico City is not a Tijuana ophthalmic hospital and not a national institute. We will not invent a PI.

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

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

• Optometry Clinic, National Autonomous University (Mexico City, Mexico): DEVICE n=10 (rank 12). INDUSTRY:10. Example NCT IDs: NCT02299869, NCT02727816, NCT02847169.

The same ranking dump has no ALL interventional row for this facility string. We will not invent an ALL n.

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

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

That is the leak: a founder searching “UNAM optometry clinical trial” or “Optometry Clinic National Autonomous University FIH” finds a DEVICE campus (n=10, rank 12, INDUSTRY:10) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, or CODET. A university optometry clinic with an all-industry DEVICE split is still a site. It is not a CRO.

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

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

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

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

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

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation at a UNAM optometry clinic is not that file, and it is not an INCan or INCMNSZ 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-site MSA will not stretch.

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

Site versus CRO

Workstream	What UNAM Optometry Clinic (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	COFEPRIS clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 UNAM optometry DEVICE string (no ALL row) — not INCMNSZ, INCan, or CODET	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS actually works (the short version)

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

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.

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

Do not smear the clinic

The UNAM optometry clinic is a real Mexico City university clinic. DEVICE n=10 (rank 12, INDUSTRY:10) is registry volume, not a punchline. Do not invent an ALL n. Do not invent a PI. Do not merge it into INCMNSZ, INCan, or CODET Tijuana. The clinic is the site, not the CRO. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract UNAM Optometry Clinic directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as INCMNSZ, INCan, or CODET Tijuana?

No. INCMNSZ is CMS 95623. Instituto Nacional de Cancerología is a separate intercept in this batch. CODET is the Tijuana ophthalmic intercept. This page is the NCT string Optometry Clinic, National Autonomous University, Mexico City, Mexico only.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the COFEPRIS / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the clinic is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Why is there no ALL n?

The dump did not publish an ALL row for this string. We cite DEVICE n=10 (rank 12, INDUSTRY:10) only. We will not invent an ALL count.

Is a university optometry clinic a CRO?

No. The clinic is the site. DEVICE n=10 does not make UNAM the COFEPRIS applicant or importer of record. We will not invent a PI.

Are the COFEPRIS clocks different from INCan on this batch?

No. Same Mexico hub: ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; combined start-up 2.8-month median; registro sanitario ~30 working days separate.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Universidad Andres Bello first-in-human, UNAB Santiago clinical trial, Universidad Andrés Bello CRO Chile, or “go direct Universidad Andrés Bello,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Andrés Bello in Santiago, Chile, is a real university string on ClinicalTrials.gov. It is an NCT university campus, not Hospital Clínico Universidad Católica. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the NCT university string only. Distinct from Hospital Clínico Universidad Católica (CMS 95626; slug hospital-clinico-universidad-catolica-santiago-fih). Different campus. Different query. We do not clone press-named TMVR claims onto this page. We will not invent a PI.

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

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

• Universidad Andrés Bello (Santiago, Chile): DEVICE n=7 (rank 23). OTHER:7. Example NCT IDs: NCT02884427, NCT03636386, NCT04008602.

The same ranking dump has no ALL interventional row for this facility string. We will not invent an ALL n.

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

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

That is the leak: a founder searching “Universidad Andrés Bello clinical trial” or “UNAB Santiago FIH” finds a DEVICE campus (n=7, rank 23, OTHER:7) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Clínico Universidad Católica. A university DEVICE string is not a CRO.

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

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

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

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

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

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on a UNAB campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-site MSA will not stretch.

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

Site versus CRO

Workstream	What Universidad Andrés Bello (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ISP clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 UNAB Santiago DEVICE string (no ALL row in the dump) — not Hospital Clínico Universidad Católica	Colombia (INVIMA) and the rest of the bioaccess® platform

How ISP actually works (the short version)

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

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.

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

Do not smear the university

Universidad Andrés Bello is a serious Santiago academic resource. DEVICE n=7 (rank 23, OTHER:7) is registry volume, not a punchline. Do not invent an ALL n. Do not merge it into Hospital Clínico Universidad Católica. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Universidad Andrés Bello directly for a device FIH?

You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, 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 campus. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as Hospital Clínico Universidad Católica (CMS 95626)?

No. CMS 95626 is Hospital Clínico Universidad Católica (hospital-clinico-universidad-catolica-santiago-fih). This page is Universidad Andrés Bello, an NCT university string only. Different campus. We do not clone that intercept’s press facts.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the ISP / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the university campus is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Why is there no ALL n?

The dump did not publish an ALL interventional row for this string. We cite DEVICE n=7 (rank 23, OTHER:7) only. We will not invent an ALL count.

Is this the same campus as Hospital Clínico Universidad Católica?

No. That is CMS 95626. Universidad Andrés Bello is a different NCT string. Sharing Santiago does not merge ISP files.

Is the 30-business-day ISP figure commercial registration?

No. Typical ISP review ~30 business days is the study/import side on Chile blogs. Commercial ISP registration 30–90 days is a different file. Law 20.120 still governs the Ethical-Scientific Committee. We will not invent PAHO/WHO Level 4 for ISP.

Next step

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

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 Erasto Gaertner as a bioaccess® client.

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

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

This page is the Curitiba Erasto Gaertner intercept. Distinct from Porto Alegre campuses (HCPA, Moinhos, PUCRS, Conceição, Dornelles, Santa Casa) and from São Paulo-state cancer campuses (ICESP, Barretos). Paraná is not Rio Grande do Sul and not the capital of São Paulo.

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; complete dump), this campus sits here after filters:

• Hospital Erasto Gaertner (Curitiba, Brazil), DEVICE list: n=5 (rank 38). INDUSTRY:2; OTHER:2; NETWORK:1. Example NCT IDs: NCT00385983, NCT03368313, NCT03721978.
• Same facility on the ALL interventional list: n=55 (rank 18). INDUSTRY:42; OTHER:11; NETWORK:2. Example NCT IDs: NCT00083304, NCT00382031, NCT00385983.

Cite DEVICE and ALL as given. NCT00385983 appears on both example sets because the dump printed it on both rows. That overlap does not merge Curitiba into Porto Alegre or ICESP.

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 campus 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 “Erasto Gaertner clinical trial” finds both a DEVICE campus (n=5, rank 38) and an ALL campus (n=55, rank 18) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, or any Porto Alegre hospital. Curitiba registry volume is still not a CRO. NETWORK tokens are not named networks we invent as clients.

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

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

Site versus CRO

Workstream	What Hospital Erasto Gaertner (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 Curitiba hospital NCT string (DEVICE and ALL listed separately) — not Porto Alegre campuses, ICESP, or Barretos	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

Use clinical-trials-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.

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.

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

Do not smear the hospital

Hospital Erasto Gaertner is a serious Curitiba resource. DEVICE n=5 (rank 38) and ALL n=55 (rank 18) are registry volume, not a punchline. Do not merge it into Porto Alegre campuses or into ICESP or Barretos. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Erasto Gaertner 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 intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as HCPA, ICESP, or Barretos Cancer Hospital?

No. HCPA is CMS 95615 (Porto Alegre). ICESP is CMS 95642 (São Paulo). Barretos is CMS 95648. This page is Hospital Erasto Gaertner, Curitiba only. DEVICE and ALL are two filters on one facility string, not two hospitals.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Why cite both DEVICE n=5 and ALL n=55?

The 1 September 2026 dump published both rows for this facility string. DEVICE rank 38 (n=5; INDUSTRY:2; OTHER:2; NETWORK:1) and ALL rank 18 (n=55; INDUSTRY:42; OTHER:11; NETWORK:2). We cite both. We do not pretend DEVICE n is ALL n.

Does NCT00385983 on both lists merge this campus with ICESP?

No. Shared example IDs across filters are facility evidence. They do not move Curitiba to São Paulo. We still will not invent a PI.

Is Curitiba a Porto Alegre alias?

No. Porto Alegre campuses stay on their own intercepts. This page is Paraná.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Instituto Nacional de Cancerologia first-in-human, INCan Mexico City clinical trial, INCan CRO Mexico, or “go direct Instituto Nacional de Cancerología,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cancerología (INCan) in Mexico City is a real national cancer-institute string on ClinicalTrials.gov. It is not INCMNSZ, not a Brazil campus, and not CODET Tijuana. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Mexico City INCan intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623; slug incmnsz-salvador-zubiran-fih — InCor HCFMUSP is Brazil and is not this campus). Distinct from CODET Vision Institute Tijuana, Hospital Universitario Eleuterio González (CMS 95643, Monterrey), Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646), and UNAM Optometry Clinic (this batch). Two national institutes in Mexico City are still two NCT strings.

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; complete dump), this campus sits here after filters:

• Instituto Nacional de Cancerologia (Mexico City, Mexico): ALL interventional n=40 (rank 40). Example NCT IDs: NCT00036647, NCT00395655, NCT00532818.

Cite ALL only as given. We will not invent a DEVICE n or a sponsor-class split the dump did not print on this instruction set.

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 campus 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 “INCan clinical trial” or “Instituto Nacional de Cancerología FIH” finds rank 40 on ALL (n=40) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, CODET, Eleuterio, Fray Antonio, or UNAM optometry. A national cancer-institute ranking is registry volume, not a CRO, and not a Brazil InCor clone.

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 local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. A hallway conversation at INCan is not that file, and it is not an INCMNSZ 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-site MSA will not stretch.

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

Site versus CRO

Workstream	What Instituto Nacional de Cancerología (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	COFEPRIS clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 INCan Mexico City NCT string — not INCMNSZ, CODET, Eleuterio, Fray Antonio, or UNAM optometry	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS actually works (the short version)

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

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.

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

Do not smear the hospital

Instituto Nacional de Cancerología is a serious Mexico City national institute. n=40 ALL (rank 40) is registry volume, not a punchline. Do not merge it into INCMNSZ, CODET Tijuana, Eleuterio Monterrey, Fray Antonio Guadalajara, or UNAM optometry. Do not paste a Brazil InCor intercept onto this slug. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Instituto Nacional de Cancerología directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as INCMNSZ, CODET Tijuana, Eleuterio González, Fray Antonio, or UNAM Optometry Clinic?

No. INCMNSZ is CMS 95623 (slug incmnsz-salvador-zubiran-fih). InCor HCFMUSP is a Brazil campus (CMS 95522). CODET is Tijuana. Eleuterio is CMS 95643 (Monterrey). Fray Antonio is CMS 95646 (Guadalajara). UNAM Optometry Clinic is a separate intercept in this batch. This page is Instituto Nacional de Cancerología, Mexico City only.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the COFEPRIS / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Is INCan the same as INCMNSZ?

No. INCMNSZ is CMS 95623. INCan is Instituto Nacional de Cancerología. Sharing Mexico City does not merge the files.

Is this InCor / HCFMUSP?

No. InCor is Brazil (CMS 95522). The INCMNSZ slug is incmnsz-salvador-zubiran-fih.

Is the 2.8-month median a guarantee for this institute?

No. It is published on the Mexico hub, not a campus-only clock. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; registro sanitario ~30 working days is separate.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Britanico de Buenos Aires first-in-human, Hospital Británico Buenos Aires clinical trial, Britanico CRO Argentina, or “go direct Hospital Británico de Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Británico de Buenos Aires is a real private hospital string on ClinicalTrials.gov. It is not HIBA, not CIPREC, not Fundación Respirar, and not Hospital Italiano de La Plata. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the unused leftover from the batch 3 Británico fallback. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), CIPREC, Fundación Respirar (this batch), Sagrada Familia / ENERI (CMS 95625), Hospital Italiano de La Plata, Hospital Universitario Austral, and Hospital Italiano Asunción. Británico is not Italiano. Linking is correct. Collapsing every Buenos Aires private hospital is not.

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

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

• Hospital Británico de Buenos Aires (Buenos Aires, Argentina): ALL interventional n=40 (rank 39). INDUSTRY:36; OTHER:3; NETWORK:1. Example NCT IDs: NCT00330369, NCT00353574, NCT00367562.

Cite ALL only as given. We will not invent a DEVICE n. NETWORK:1 is a registry sponsor-class token, not a named network we will invent as a client.

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 campus 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 Británico Buenos Aires clinical trial” finds rank 39 on ALL (n=40, INDUSTRY:36; OTHER:3; NETWORK:1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, CIPREC, Respirar, ENERI, La Plata, or Austral. Batch 3 kept Barretos instead of swapping this campus. The leftover still needs an intercept. Registry volume is still 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 local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation at Hospital Británico is not that file. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
• 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-site MSA will not stretch.

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

Site versus CRO

Workstream	What Hospital Británico de Buenos Aires (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 Hospital Británico Buenos Aires NCT string — not HIBA, CIPREC, Respirar, ENERI, La Plata, Austral, or Asunción	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.

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.

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

Do not smear the hospital

Hospital Británico de Buenos Aires is a serious Buenos Aires resource. n=40 ALL (rank 39) is registry volume, not a punchline. Do not merge it into HIBA, CIPREC, Respirar, ENERI, La Plata, Austral, or Asunción. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Británico de Buenos Aires directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, 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 intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as HIBA, CIPREC, Respirar, ENERI, La Plata, Austral, or Asunción Italiano?

No. HIBA is CMS 95620. CIPREC is a separate intercept. Fundación Respirar is a separate intercept in this batch. ENERI is CMS 95625. La Plata is CMS 95647. Austral is CMS 95638. Asunción is CMS 95517. This page is Hospital Británico de Buenos Aires only — the unused leftover from the batch 3 Británico fallback.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Was this campus swapped for Barretos in batch 3?

Batch 3 kept Barretos and left Hospital Británico unused. This page ships the leftover. It does not clone Barretos or HIBA.

Is Británico the same as Hospital Italiano de Buenos Aires?

No. HIBA is CMS 95620. Británico is a different NCT string (ALL n=40, rank 39).

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Fundación Respirar first-in-human, Fundacion Respirar Buenos Aires clinical trial, Respirar CRO Argentina, or “go direct Fundación Respirar,” you followed a campus string ClinicalTrials.gov still publishes. Fundación Respirar in Buenos Aires, Argentina, is a real facility string on ClinicalTrials.gov. It is a named foundation campus. It is not a hospital CRO we invent, and it is not CIPREC or Hospital Británico. 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 foundation is the site. The First-in-Human CRO still owns ANMAT, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the foundation still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Fundación Respirar Buenos Aires intercept. Distinct from CIPREC (CMS 95641), Hospital Italiano de Buenos Aires (CMS 95620), Sagrada Familia / ENERI (CMS 95625), and Hospital Británico de Buenos Aires (this batch). We will not invent a PI. We will not invent that this foundation is a hospital CRO.

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; complete dump), this campus sits here after filters:

• Fundación Respirar (Buenos Aires, Argentina): ALL interventional n=40 (rank 38). INDUSTRY:40. Example NCT IDs: NCT03656510, NCT03952559, NCT04557449.

Cite ALL only as given. We will not invent a DEVICE n. INDUSTRY:40 is the entire sponsor-class split on that row — not a bioaccess® claim and not a PI we invent.

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 campus 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 foundation as a client site.

That is the leak: a founder searching “Fundación Respirar clinical trial” finds rank 38 on ALL (n=40, INDUSTRY:40) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on CIPREC, HIBA, ENERI, or Británico. A foundation string with an all-industry split is still a site string. It is not a CRO, and it is not a hospital we relabel.

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

A named foundation 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 foundation 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 local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the foundation 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 at Fundación Respirar is not that file. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
• 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-site MSA will not stretch.

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

Site versus CRO

Workstream	What Fundación Respirar (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 Fundación Respirar Buenos Aires NCT string — not CIPREC, HIBA, ENERI, or Británico	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway, including clinical-trials-argentina. 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.

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.

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

Do not smear the foundation

Fundación Respirar is a real Buenos Aires facility string with n=40 ALL. That volume is not a punchline. We will not smear it by inventing a PI, a hospital-CRO label, or a client claim. Do not merge it into CIPREC, HIBA, ENERI, or Británico. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Fundación Respirar directly for a device FIH?

You can try. The foundation 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 foundation. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

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

No. CIPREC is CMS 95641. HIBA is CMS 95620. Sagrada Familia / ENERI is CMS 95625. Hospital Británico de Buenos Aires is a separate intercept in this batch. This page is Fundación Respirar only. We will not invent that it is a hospital CRO.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the ANMAT / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the foundation is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Is Fundación Respirar a hospital CRO?

No. Ranking on ALL does not turn a foundation into a first-in-human medical-device CRO. We will not invent that claim or a PI.

Does INDUSTRY:40 mean bioaccess® ran those studies?

No. It is the sponsor-class split on the ALL row (n=40, rank 38). Public NCT ranking only.

Is the 90-business-day figure a guarantee of start-up?

No. It is a published statutory target and the clock pauses for RFIs. Trial versus registro are separate.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Amaral Carvalho first-in-human, Amaral Carvalho Jaú clinical trial, Hospital Amaral Carvalho CRO, or “go direct Hospital Amaral Carvalho,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Amaral Carvalho in Jaú, Brazil, is a real hospital string on ClinicalTrials.gov. Jaú is not Barretos, not São José do Rio Preto, and not São Paulo capital. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Jaú Amaral Carvalho intercept. Distinct from Barretos Cancer Hospital (CMS 95648), FAMERP (CMS 95639), and ICESP (CMS 95642). Interior São Paulo state has more than one cancer campus. Sharing a state is not a license to collapse them.

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

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

• Hospital Amaral Carvalho (Jaú, Brazil): ALL interventional n=41 (rank 35). INDUSTRY:36; OTHER:4; OTHER_GOV:1. Example NCT IDs: NCT00069121, NCT00412776, NCT00545688.

Cite ALL only as given. We will not invent a DEVICE n. OTHER_GOV:1 is a registry sponsor-class token, not a named ministry we will invent as a client.

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 campus 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 “Amaral Carvalho clinical trial” or “Jaú FIH hospital” finds rank 35 on ALL (n=41, INDUSTRY:36; OTHER:4; OTHER_GOV:1) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on Barretos, FAMERP, or ICESP. Interior São Paulo is still not a CRO product, and not a claim that bioaccess® ran any of those IDs.

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 local 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. A hallway conversation in Jaú is not that dossier, and it is not a Barretos, FAMERP, or ICESP 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-site MSA will not stretch.

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

Site versus CRO

Workstream	What Hospital Amaral Carvalho (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university 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 Jaú hospital NCT string — not Barretos, FAMERP, or ICESP	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

Use clinical-trials-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.

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.

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

Do not smear the hospital

Hospital Amaral Carvalho is a serious Jaú resource. n=41 ALL (rank 35) is registry volume, not a punchline. Do not merge it into Barretos, FAMERP, or ICESP. Do not smear those campuses by collapsing every interior São Paulo cancer string. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Amaral Carvalho 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 intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as Barretos, FAMERP, or ICESP?

No. Barretos is CMS 95648. FAMERP is CMS 95639 (São José do Rio Preto). ICESP is CMS 95642 (São Paulo capital). This page is Hospital Amaral Carvalho, Jaú only.

If I already have this campus, what does the CRO still do?

Regulatory-fit (this country versus Colombia versus a multi-site design); the ANVISA / ethics packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one room is not enough.

Does a high n on ClinicalTrials.gov mean the hospital is a device CRO?

No. n is unique NCT IDs per facility string. It is registry volume. It is not ISO 14155 monitoring, not an importer of record, and not a 21 CFR 812.28 package. Use the site when the protocol fits. Hire the operator.

Is Jaú the same metro as Barretos?

No. Barretos is a different city and a DEVICE-row campus on the dump. Amaral Carvalho is a Jaú ALL-row campus (n=41, rank 35). City fields on ClinicalTrials.gov are not a license to merge them.

What does OTHER_GOV:1 mean?

It is the sponsor-class split on the ALL row. We will not invent that party as a client. We will not invent a PI.

Does rank 35 ALL mean this campus already owns ANVISA?

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®