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 Hospital Geral de Fortaleza as a bioaccess® client.

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

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

This page is the named Fortaleza general hospital. It is not CRIO Fortaleza (CMS 95735; NCT overlap 0 on this canonical string). Sharing Fortaleza 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:

Counts come from leftover unique strings after batch 12 (CMS 95729–95738 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies. Rank 8 is a press-named building (Innoblative SIRA RFA FIH, public LinkedIn May 2026), not an NCT frequency row.

• Hospital Geral de Fortaleza (Fortaleza, Brazil) — canonical NCT string: ALL interventional n=19; DEVICE n=3. Example NCT IDs: NCT01174524, NCT02084446, NCT02098252.

Cite canonical ALL n=19 and DEVICE n=3. Do not clone CRIO onto this slug.

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

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

That is the leak: a founder searching “Hospital Geral de Fortaleza first-in-human” finds ALL n=19 (DEVICE n=3) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CRIO. A named Fortaleza hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

Hospital Geral de Fortaleza is a serious named Fortaleza hospital on the public registry. ALL n=19 / DEVICE n=3 is registry volume, not a punchline. Do not clone CRIO. Do not invent a PI. 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 Geral de Fortaleza 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 CRIO Fortaleza?

No. CRIO is CMS 95735 (overlap 0 on this canonical string). This page is Hospital Geral de Fortaleza only.

Is this CRIO?

No. That is CMS 95735. Same city is not the same NCT string.

Did bioaccess® run NCT01174524?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

This page is the named Buenos Aires Maffei research center. It is not CIPREC (CMS 95641), not CINME (CMS 95669), not Clínica la Sagrada Familia ENERI (CMS 95625), and not Hospital Italiano Buenos Aires (CMS 95620). Sharing Buenos Aires is not a license to collapse them. We do not invent a PI from the center’s name.

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 leftover unique strings after batch 12 (CMS 95729–95738 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies. Rank 8 is a press-named building (Innoblative SIRA RFA FIH, public LinkedIn May 2026), not an NCT frequency row.

• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=29; DEVICE n=0. Example NCT IDs: NCT04255433, NCT04847557, NCT05508789.

Cite canonical ALL n=29 and DEVICE n=0. We will not invent a DEVICE ranking.

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

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

That is the leak: a founder searching “Laura Maffei first-in-human” or “Maffei Investigacion Clinica Aplicada clinical trial” finds ALL n=29 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28. A named research center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Do not smear the center

Centro Médico Laura Maffei is a serious named Buenos Aires research center on the public registry. ALL n=29 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. 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 Centro Médico Laura Maffei Buenos Aires directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as CIPREC, CINME, or Clínica la Sagrada Familia ENERI?

No. CIPREC is CMS 95641. CINME is CMS 95669. Sagrada Familia ENERI is CMS 95625. This page is the Maffei Investigacion Clinica Aplicada string only.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=29 is still not ANMAT authorization.

Did bioaccess® run NCT04255433?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires siblings (do not merge): CINME, Sagrada Familia ENERI.

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 Instituto Médico Catamarca IMEC Rosario as a bioaccess® client.

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

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

This page is the named Rosario IMEC institute. It is not Instituto CAICI (this batch; NCT overlap 0), not Instituto de Investigaciones Clínicas Rosario (CMS 95723), not Instituto de Oncología de Rosario (CMS 95704), and not Instituto Médico Río Cuarto (CMS 95679). Sharing Rosario or sharing an “Instituto Médico” token is not a license to collapse them. Punctuation alias Instituto Médico Catamarca – IMEC stays on this slug; we do not ship a second slug.

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 leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto Médico Catamarca IMEC (Rosario, Argentina) — canonical NCT string: ALL interventional n=20; DEVICE n=0. Example NCT IDs: NCT04255433, NCT04660643, NCT05275400.
• Punctuation alias Instituto Médico Catamarca – IMEC: ALL n=3. Listed separately. Same slug. No unique-study union of 20+3. No second slug.

Cite canonical ALL n=20 and DEVICE n=0. Cite alias ALL n=3 separately. Do not add them. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “IMEC Rosario first-in-human” or “Instituto Médico Catamarca clinical trial” finds canonical ALL n=20 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CAICI, IIC Rosario, Oncología Rosario, or Río Cuarto. A named institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANMAT actually works (the short version)

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

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

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

Do not smear the institute

Instituto Médico Catamarca IMEC is a serious named Rosario medical institute on the public registry. ALL n=20 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CAICI, IIC Rosario, Oncología Rosario, or Río Cuarto. Do not invent a PI. 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 Instituto Médico Catamarca IMEC Rosario directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Instituto CAICI, IIC Rosario, or Instituto Médico Río Cuarto?

No. CAICI is a different Rosario organization on its own slug in this batch (overlap 0). IIC Rosario is CMS 95723. Instituto Médico Río Cuarto is CMS 95679 in another city. This page is Instituto Médico Catamarca IMEC, Rosario only. Punctuation ALL n=3 stays listed separately; we do not union.

Should I add canonical ALL n=20 and punctuation ALL n=3?

No. Alias n is listed separately. A unique-study union is not published. The hyphen stays on this slug.

Is this Instituto CAICI or IIC Rosario?

No. CAICI is this batch, a different NCT string (overlap 0). IIC Rosario is CMS 95723. Sharing Rosario is not a merge.

Is this Instituto Médico Río Cuarto?

No. That is CMS 95679. “Instituto Médico” in the name is not a merge key.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=20 is still not ANMAT authorization. Trial versus registro remain different petitions.

Did bioaccess® run NCT04255433?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

bioaccess®’s position is simple and it is not adversarial: the 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 named Mexico City pediatric hospital. It is not Instituto Nacional de Cancerología (CMS 95655; NCT overlap 0), not INCMNSZ Salvador Zubirán (CMS 95623), and not Instituto Nacional de Cardiología Ignacio Chávez (CMS 95710). Sharing Mexico City is not a license to collapse them. Accent alias Hospital Infantil de México Federico Gómez stays on this slug; we do not ship a second slug.

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 leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Infantil de Mexico Federico Gomez (Mexico City, Mexico) — canonical NCT string: ALL interventional n=20; DEVICE n=0. Example NCT IDs: NCT00791700, NCT01056341, NCT02530346.
• Accent alias Hospital Infantil de México Federico Gómez: ALL n=10. Listed separately. Same slug. No unique-study union of 20+10. No second slug.

Cite canonical ALL n=20 and DEVICE n=0. Cite alias ALL n=10 separately. Do not add them. We will not invent a DEVICE n. Do not clone INCan, INCMNSZ, or Ignacio Chávez onto this slug.

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

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

That is the leak: a founder searching “Hospital Infantil Federico Gómez first-in-human” or “HIMFG clinical trial” finds canonical ALL n=20 (DEVICE n=0) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on INCan, INCMNSZ, or Ignacio Chávez. A named pediatric hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How COFEPRIS actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Infantil de Mexico Federico Gomez is a serious named Mexico City pediatric hospital on the public registry. ALL n=20 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into INCan, INCMNSZ, or Ignacio Chávez. Do not invent a PI. 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 Hospital Infantil Federico Gómez Mexico City 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.

Is this the same page as INCan, INCMNSZ, or Instituto Nacional de Cardiología Ignacio Chávez?

No. INCan is CMS 95655 (overlap 0). INCMNSZ is CMS 95623. Ignacio Chávez is CMS 95710. This page is Hospital Infantil de Mexico Federico Gomez only. Accent ALL n=10 stays listed separately; we do not union.

Should I add canonical ALL n=20 and accent ALL n=10?

No. Alias n is listed separately. A unique-study union is not published. The accents stay on this slug.

Is this INCan or Ignacio Chávez?

No. Those are already-live Mexico City institute intercepts. This page is the pediatric hospital string.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=20 is still not COFEPRIS authorization. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub.

Did bioaccess® run NCT00791700?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico City siblings (do not merge): INCan, Ignacio Chávez.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital das Clínicas Ribeirão Preto first-in-human, HCFMRP USP clinical trial, FMRP Hospital das Clínicas CRO, or “go direct Hospital das Clínicas Ribeirão Preto,” you followed a campus string ClinicalTrials.gov still publishes. Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo is a real named teaching-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Ribeirão Preto teaching hospital. It is not Hospital das Clínicas FMUSP in São Paulo (CMS 95630) and it is not University of São Paulo in São Paulo (CMS 95616). Ribeirão Preto is not São Paulo city. Sharing a USP token is not a license to collapse them. Short alias Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto stays on this slug; we do not ship a second slug. University of Sao Paulo Ribeirão Preto is a university string — not this hospital slug and not a second slug.

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 leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (Ribeirão Preto, Brazil) — canonical NCT string: ALL interventional n=20; DEVICE n=0. Example NCT IDs: NCT00315133, NCT00801450, NCT01190163.
• Short alias Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto: ALL n=17. Listed separately. Same slug. No union of 20+17. No second slug.

Cite canonical ALL n=20 and DEVICE n=0. Cite short ALL n=17 separately. Do not add them. Do not clone HCFMUSP or USP São Paulo onto this slug. University of Sao Paulo Ribeirão Preto stays off this hospital slug.

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

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

That is the leak: a founder searching “Hospital das Clínicas Ribeirão Preto first-in-human” or “HCFMRP clinical trial” finds canonical ALL n=20 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on HCFMUSP or USP São Paulo. A named Ribeirão Preto teaching hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at HCFMRP is not an HCFMUSP São Paulo file and is not a USP São Paulo 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

Hospital das Clínicas Ribeirão Preto is a serious named teaching hospital on the public registry. ALL n=20 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into HCFMUSP or USP São Paulo. Do not invent a PI. 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 das Clínicas Ribeirão Preto directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital das Clínicas FMUSP or University of São Paulo?

No. HCFMUSP is CMS 95630 in São Paulo. University of São Paulo is CMS 95616 in São Paulo. This page is Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto only. Short ALL n=17 stays listed separately; we do not union. The Ribeirão Preto university string is not this hospital slug.

Should I add canonical ALL n=20 and short ALL n=17?

No. Alias n is listed separately. A unique-study union is not published. The short Faculdade string stays on this slug.

Is this HCFMUSP or USP São Paulo?

No. Those are São Paulo-city intercepts. Ribeirão Preto versus São Paulo is the filter.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=20 is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.

Did bioaccess® run NCT00315133?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. USP siblings (do not merge): Hospital das Clínicas FMUSP, University of São Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched CRIO Fortaleza first-in-human, Centro Regional Integrado de Oncologia clinical trial, CRIO CRO Brazil, or “go direct CRIO Fortaleza,” you followed a campus string ClinicalTrials.gov still publishes. Crio – Centro Regional Integrado de Oncologia in Fortaleza, Brazil, is a real named oncology-center string on ClinicalTrials.gov. This is the first Fortaleza slug in this intercept series. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Fortaleza oncology center. It is not Hospital Geral de Fortaleza (a different NCT string; overlap 0 on this canonical string) and it is not Liga Norte Riograndense (CMS 95659 in Natal). Sharing a Northeast Brazil oncology search is not a license to collapse them. Casing alias CRIO – Centro Regional Integrado de Oncologia stays on this slug; we do not ship a second slug.

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 leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Crio – Centro Regional Integrado de Oncologia (Fortaleza, Brazil) — canonical NCT string: ALL interventional n=20; DEVICE n=0. Example NCT IDs: NCT00567190, NCT01649856, NCT02425891.
• Casing alias CRIO – Centro Regional Integrado de Oncologia: ALL n=11. Listed separately. Same slug. No unique-study union of 20+11. No second slug for the capitals.

Cite canonical ALL n=20 and DEVICE n=0. Cite alias ALL n=11 separately. Do not add them. We will not invent a DEVICE n. First Fortaleza slug.

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

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

That is the leak: a founder searching “CRIO Fortaleza first-in-human” or “Centro Regional Integrado de Oncologia clinical trial” finds canonical ALL n=20 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Geral de Fortaleza or Liga Norte. A named Fortaleza oncology center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at CRIO is not a Hospital Geral de Fortaleza file and is not a Liga Norte 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 center

Crio – Centro Regional Integrado de Oncologia is a serious named Fortaleza oncology center on the public registry. ALL n=20 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Hospital Geral de Fortaleza or Liga Norte. Do not invent a PI. 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 CRIO Fortaleza directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Geral de Fortaleza or Liga Norte Riograndense?

No. Hospital Geral de Fortaleza is a different NCT string (overlap 0). Liga Norte is CMS 95659 in Natal. This page is CRIO, Fortaleza only. CRIO ALL n=11 stays listed separately; we do not union.

Should I add canonical ALL n=20 and CRIO ALL n=11?

No. Alias n is listed separately. A unique-study union is not published. The capitals are the same Fortaleza campus on the same slug.

Is this Hospital Geral de Fortaleza?

No. Same city is not the same NCT string. Overlap is 0.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=20 is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.

Did bioaccess® run NCT00567190?

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

Next step

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

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 Araújo Jorge Goiânia as a bioaccess® client.

If you searched Hospital Araujo Jorge first-in-human, Araújo Jorge Goiânia clinical trial, Hospital de Câncer Araújo Jorge CRO, or “go direct Hospital Araújo Jorge Goiânia,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Araujo Jorge in Goiânia, Brazil, is a real named cancer-hospital string on ClinicalTrials.gov. This is the first Goiânia slug in this intercept series. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Goiânia cancer hospital. It is not Barretos (CMS 95648), not A.C. Camargo (CMS 95691), and not ICESP (CMS 95642). Sharing a Brazilian oncology search is not a license to collapse them. Goiânia is not Barretos and is not São Paulo. Accent alias Hospital Araújo Jorge and legal-name Associacao de Combate ao Cancer em Goias – Hospital de Cancer Araujo Jorge stay on this slug; we do not ship second slugs.

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 leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Araujo Jorge (Goiânia, Brazil) — canonical NCT string: ALL interventional n=20; DEVICE n=1. Example NCT IDs: NCT00385983, NCT01844986, NCT01874353.
• Accent alias Hospital Araújo Jorge: ALL n=5. Listed separately. Same slug. No union. No second slug.
• Legal-name alias Associacao de Combate ao Cancer em Goias – Hospital de Cancer Araujo Jorge: ALL n=6. Listed separately. Same slug. No union. No second slug.

Cite canonical ALL n=20 and DEVICE n=1. Cite alias n separately. Do not add 20+5+6. Do not clone Barretos, Camargo, or ICESP onto this slug.

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

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

That is the leak: a founder searching “Hospital Araújo Jorge first-in-human” or “Araujo Jorge Goiânia clinical trial” finds canonical ALL n=20 (DEVICE n=1) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Barretos, Camargo, or ICESP. A named Goiânia cancer hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

Hospital Araujo Jorge is a serious named Goiânia cancer hospital on the public registry. ALL n=20 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into Barretos, Camargo, or ICESP. Do not invent a PI. 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 Araújo Jorge Goiânia 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, A.C. Camargo, or ICESP?

No. Barretos is CMS 95648. A.C. Camargo is CMS 95691. ICESP is CMS 95642. This page is Hospital Araujo Jorge, Goiânia only. First Goiânia slug. Accent ALL n=5 and Associação ALL n=6 stay listed separately; we do not union.

Should I add canonical ALL n=20, accent ALL n=5, and Associação ALL n=6?

No. Alias n is listed separately. A unique-study union is not published. Those strings stay on this slug.

Is this Barretos or Camargo?

No. Those are already-live Brazilian oncology intercepts in other cities. This page is the Goiânia named hospital.

Why DEVICE n=1?

That is the ranking-table DEVICE count. It is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.

Did bioaccess® run NCT00385983?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Oncology siblings (do not merge): Barretos, A.C. Camargo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

This page is the named Lima hospital. It is not INEN (CMS 95644; NCT overlap 1) and it is not Hospital Nacional Cayetano Heredia (CMS 95697; overlap 2). Sharing Lima is not a license to collapse them. City-label alias Hospital Nacional Arzobispo Loayza in Lima Cercado stays on this slug; we do not ship a second slug. We do not invent a Peruvian legal entity on this page.

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

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

Counts come from leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Nacional Arzobispo Loayza (Lima, Peru) — canonical NCT string: ALL interventional n=20; DEVICE n=2. Example NCT IDs: NCT00653172, NCT00868959, NCT00876798.
• City-label alias Hospital Nacional Arzobispo Loayza (Lima Cercado, Peru): ALL n=3. Listed separately. Same slug. No union of 20+3. No second slug.

Cite canonical ALL n=20 and DEVICE n=2. Cite Lima Cercado ALL n=3 separately. Do not add them. Do not clone INEN or Cayetano onto this slug. We do not invent a Peruvian legal entity.

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 “Arzobispo Loayza first-in-human” or “Hospital Nacional Arzobispo Loayza clinical trial” finds canonical ALL n=20 (DEVICE n=2) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28 — and without landing on INEN or Cayetano Heredia. A named Lima hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page. We do not invent a Peruvian legal entity. A hallway conversation at Loayza is not an INEN file and is not a Cayetano Heredia file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How INS actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Nacional Arzobispo Loayza is a serious named Lima national hospital on the public registry. ALL n=20 and DEVICE n=2 are registry volume, not a punchline. Do not merge it into INEN or Cayetano. Do not invent a Peruvian legal entity. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Nacional Arzobispo Loayza Lima directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as INEN Lima or Hospital Nacional Cayetano Heredia?

No. INEN is CMS 95644 (overlap 1). Cayetano Heredia hospital is CMS 95697 (overlap 2). This page is Hospital Nacional Arzobispo Loayza only. Lima Cercado ALL n=3 stays listed separately; we do not union.

Should I add canonical ALL n=20 and Lima Cercado ALL n=3?

No. Alias n is listed separately. A unique-study union is not published. Lima Cercado is a city-label on this slug.

Is this INEN or Cayetano Heredia?

No. INEN is CMS 95644. Hospital Nacional Cayetano Heredia is CMS 95697. Sharing Lima is not a merge.

Is DIGEMID the only agency?

No. Name both. INS (DIIS, formerly OGITT) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. We will not invent DIGESA.

Did bioaccess® run NCT00653172?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Lima siblings (do not merge): INEN Lima, Hospital Nacional Cayetano Heredia.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Carlos Van Buren first-in-human, Van Buren Valparaíso clinical trial, Hospital Carlos Van Buren CRO Chile, or “go direct Hospital Carlos Van Buren Valparaíso,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Carlos Van Buren in Valparaíso, Chile, is a real named public-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the named Valparaíso hospital. It is not Hospital Clínico Universidad Católica (CMS 95626), not Hospital Clínico Universidad de Chile (CMS 95665), not Universidad Andrés Bello (CMS 95657), not FALP (CMS 95698), and not Biomedica Research Group Santiago (CMS 95726). Valparaíso is not Santiago. Sharing Chile 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:

Counts come from leftover unique strings after batch 11 (CMS 95719–95728 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Carlos Van Buren (Valparaíso, Chile) — canonical NCT string: ALL interventional n=20; DEVICE n=3. Example NCT IDs: NCT00022516, NCT00403208, NCT00553410.

Cite canonical ALL n=20 and DEVICE n=3. We will not invent an alias union with Santiago university hospitals. We will not invent PAHO/WHO Level 4 standing for ISP.

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

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

That is the leak: a founder searching “Hospital Carlos Van Buren first-in-human” or “Van Buren Valparaíso clinical trial” finds canonical ALL n=20 (DEVICE n=3) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, FALP, or Biomedica Santiago. A named Valparaíso hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ISP actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Carlos Van Buren is a serious named Valparaíso public hospital on the public registry. ALL n=20 and DEVICE n=3 are registry volume, not a punchline. Do not invent PAHO/WHO Level 4 for ISP. Do not merge it into Santiago campuses. Do not invent a PI. 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 Hospital Carlos Van Buren Valparaíso directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Católica, UChile, FALP, or Biomedica Research Group Santiago?

No. Católica is CMS 95626. UChile is CMS 95665. FALP is CMS 95698. Biomedica Santiago is CMS 95726. This page is Hospital Carlos Van Buren, Valparaíso only.

Is this a Santiago university hospital?

No. Valparaíso versus Santiago is the filter. Católica, UChile, UNAB, FALP, and Biomedica Santiago stay on their own slugs.

Does ISP have PAHO/WHO Level 4 standing?

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

Why DEVICE n=3?

That is the ranking-table DEVICE count. It is still not ISP authorization.

Did bioaccess® run NCT00022516?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®