Category: Preparing for First-In-Human Studies

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 UNESP Faculdade de Medicina Campus Botucatu as a bioaccess® client.

If you searched UNESP Botucatu first-in-human, Faculdade de Medicina de Botucatu clinical trial, UNESP CRO Brazil, or “go direct UNESP Faculdade de Medicina Campus Botucatu,” you followed a campus string ClinicalTrials.gov still publishes. UNESP – Faculdade de Medicina da Universidade Estadual Paulista – Campus Botucatu is a real named medical-school campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Botucatu medical-school campus. It is not University of São Paulo (CMS 95616), not UNIFESP (CMS 95632), and not University of Campinas / UNICAMP (CMS 95706). Sharing a São Paulo-state university search is not a license to collapse them. Botucatu is not São Paulo city and is not Campinas. Aliases Faculdade de Medicina de Botucatu – UNESP and Faculdade de Medicina da UNESP stay on this slug; we do not ship second slugs. UNESP Presidente Prudente or Araraquara strings are other campuses, not this row 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• UNESP – Faculdade de Medicina da Universidade Estadual Paulista – Campus Botucatu (Botucatu, Brazil) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT02100696, NCT02118584, NCT02163759.
• Alias Faculdade de Medicina de Botucatu – UNESP: ALL n=8. Listed separately. Same slug. No union.
• Alias Faculdade de Medicina da UNESP: ALL n=8. Listed separately. Same slug. No union.

Cite canonical ALL n=22 and DEVICE n=0. Cite each alias n separately. Do not add 22+8+8. We will not invent a DEVICE n. We do not clone USP, UNIFESP, or UNICAMP 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 campus as a client site.

That is the leak: a founder searching “UNESP Botucatu first-in-human” or “Faculdade de Medicina de Botucatu clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on USP, UNIFESP, or UNICAMP. A named medical-school campus is still a site. An NCT location row is not a CRO.

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

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

What the campus 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 UNESP Botucatu is not a USP file, not a UNIFESP file, and not a UNICAMP 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 campus

UNESP Faculdade de Medicina Campus Botucatu is a serious named Botucatu medical-school campus on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into USP, UNIFESP, or UNICAMP. 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 UNESP Faculdade de Medicina Campus Botucatu directly for a device FIH?

You can try. The campus 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 campus. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as USP, UNIFESP, or UNICAMP?

No. USP is CMS 95616. UNIFESP is CMS 95632. UNICAMP is CMS 95706. This page is UNESP Faculdade de Medicina Campus Botucatu only. Alias ALL n=8 and ALL n=8 stay listed separately; we do not union. Other UNESP cities are not this row and not a second slug.

Should I add canonical ALL n=22 and the two ALL n=8 aliases?

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

Is this USP, UNIFESP, or UNICAMP?

No. Those are already-live university intercepts. Botucatu is a different campus and a different NCT string.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 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 NCT02100696?

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Ruschel Medicina e Pesquisa Clínica first-in-human, Ruschel Rio de Janeiro clinical trial, Ruschel CRO Brazil, or “go direct Ruschel Medicina e Pesquisa Clínica,” you followed a campus string ClinicalTrials.gov still publishes. Ruschel Medicina e Pesquisa Clínica in Rio de Janeiro, 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 named Rio research clinic. It is not IBPClin (CMS 95702). NCT overlap with IBPClin – Instituto Brasil de Pesquisa Clínica is 6 on this canonical string. Link it as a sibling; do not clone CMS 95702. It is not Universidade Federal do Rio de Janeiro (CMS 95707). Legal-suffix alias Ruschel Medicina e Pesquisa Clínica Ltda 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• Ruschel Medicina e Pesquisa Clínica (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT03571568, NCT04846881, NCT04860830.
• Legal-suffix alias Ruschel Medicina e Pesquisa Clínica Ltda: ALL n=7. Listed separately. Same slug. We do not invent a unique-study union of 22+7. We do not ship a second slug for Ltda.

Cite canonical ALL n=22 and DEVICE n=0. Cite Ltda ALL n=7 separately. Do not add them. Do not clone IBPClin counts onto this page. 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 clinic as a client site.

That is the leak: a founder searching “Ruschel Rio first-in-human” or “Ruschel Medicina e Pesquisa Clínica clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on IBPClin or UFRJ. A named Rio clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 Ruschel is not an IBPClin file and is not a UFRJ 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

Ruschel Medicina e Pesquisa Clínica is a serious named Rio research clinic on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not clone IBPClin. Do not merge it into UFRJ. 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 Ruschel Medicina e Pesquisa Clínica 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 IBPClin or Universidade Federal do Rio de Janeiro?

No. IBPClin is CMS 95702 — a different organization (NCT overlap 6 on this canonical string). Link it; do not merge it. UFRJ is CMS 95707. This page is Ruschel Medicina e Pesquisa Clínica only. Ltda ALL n=7 stays listed separately; we do not union.

Should I add canonical ALL n=22 and Ltda ALL n=7?

No. Alias n is listed separately. A unique-study union is not published. The Ltda suffix is the same Rio campus on the same slug.

Is this IBPClin?

No. IBPClin is CMS 95702. NCT overlap is 6. We link that page as a sibling. We do not clone it.

Is this UFRJ?

No. Universidade Federal do Rio de Janeiro is CMS 95707. Sharing Rio de Janeiro is not a merge.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 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 NCT03571568?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Rio siblings (do not merge): IBPClin, Universidade Federal do Rio de Janeiro.

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 de Investigaciones Clínicas Rosario as a bioaccess® client.

If you searched Instituto de Investigaciones Clinicas Rosario first-in-human, IIC Rosario clinical trial, IIC Rosario CRO Argentina, or “go direct Instituto de Investigaciones Clínicas Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Investigaciones Clinicas Rosario in Rosario, Argentina, is a real named clinical-research-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 institute. It is city-distinct from Instituto de Investigaciones Clínicas Quilmes (CMS 95709) and Instituto de Investigaciones Clínicas Mar del Plata (CMS 95714). It is not Instituto de Oncología de Rosario (CMS 95704), not Hospital Provincial del Centenario (CMS 95649), and not INECO Neurociencias Oroño (CMS 95663). Sharing Rosario or sharing an IIC token is not a license to collapse them. Alias Instituto de Investigaciones Clinicas de Rosario 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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 de Investigaciones Clinicas Rosario (Rosario, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT01975376, NCT03891524, NCT03968393.
• Spelling alias Instituto de Investigaciones Clinicas de Rosario: ALL n=10. Listed separately. Same slug. We do not invent a unique-study union of 22+10. We do not ship a second slug for the extra “de.”

Cite canonical ALL n=22 and DEVICE n=0. Cite alias ALL n=10 separately. Do not add them. We will not invent a DEVICE n. NCT overlap with Instituto de Oncología de Rosario is 0.

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 “IIC Rosario first-in-human” or “Instituto de Investigaciones Clínicas Rosario clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Oncología Rosario, Centenario, INECO, IIC Quilmes, or IIC Mar del Plata. 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 IIC Rosario is not an Oncología Rosario file, not a Centenario file, not an INECO file, and not an IIC Quilmes or IIC Mar del Plata 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 de Investigaciones Clinicas Rosario is a serious named Rosario research institute on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Oncología Rosario, Centenario, INECO, IIC Quilmes, or IIC Mar del Plata. 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 de Investigaciones Clínicas 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 de Oncología de Rosario, Centenario Rosario, INECO, IIC Quilmes, or IIC Mar del Plata?

No. Oncología Rosario is CMS 95704 (NCT overlap 0). Centenario is CMS 95649. INECO is CMS 95663. IIC Quilmes is CMS 95709. IIC Mar del Plata is CMS 95714. This page is Instituto de Investigaciones Clinicas Rosario only. “De Rosario” ALL n=10 stays listed separately; we do not union.

Should I add canonical ALL n=22 and “de Rosario” ALL n=10?

No. Alias n is listed separately. A unique-study union is not published. The extra “de” is the same Rosario IIC campus on the same slug.

Is this Instituto de Oncología de Rosario, IIC Quilmes, or IIC Mar del Plata?

No. Oncología Rosario is CMS 95704 (overlap 0). IIC Quilmes is CMS 95709. IIC Mar del Plata is CMS 95714. This page is Rosario only.

Why DEVICE n=0?

That is the ranking-table DEVICE count. We will not invent a DEVICE ranking. ALL n=22 is still not ANMAT authorization. Trial versus registro remain different petitions.

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 de Oncología de Rosario, Hospital Provincial del Centenario, INECO Neurociencias Oroño. Other IIC cities (do not merge): IIC Quilmes, IIC Mar del Plata.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital de Base do Distrito Federal first-in-human, HBDF Brasília clinical trial, Hospital de Base Brasília CRO, or “go direct Hospital de Base do Distrito Federal,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Base do Distrito Federal in Brasília, Brazil, 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 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 Brasília public hospital. It is not FAMERP / Hospital de Base de São José do Rio Preto (CMS 95639). NCT overlap with the canonical SJRP string is 0. The prior “Hospital de Base” skip was the SJRP campus only. Sharing the “Hospital de Base” token is not a license to collapse Brasília into Rio Preto. Alias Instituto Hospital de Base do Distrito Federal 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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 de Base do Distrito Federal (Brasília, Brazil) — canonical NCT string: ALL interventional n=22; DEVICE n=1. Example NCT IDs: NCT00294658, NCT00905905, NCT00906451.

Cite canonical ALL n=22 and DEVICE n=1. We will not invent an alias union with FAMERP / Hospital de Base SJRP. We do not clone CMS 95639. Instituto Hospital de Base do Distrito Federal stays on this slug, not a second 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 de Base Brasília first-in-human” or “HBDF clinical trial” finds canonical ALL n=22 (DEVICE n=1) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on FAMERP / Hospital de Base SJRP. A named Brasília 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 HBDF is not a FAMERP / São José do Rio Preto Hospital de Base file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

Use clinical-trials-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 de Base do Distrito Federal is a serious named Brasília public hospital on the public registry. ALL n=22 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into FAMERP or Hospital de Base SJRP. 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 de Base do Distrito Federal 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 FAMERP or Hospital de Base de São José do Rio Preto?

No. FAMERP / Hospital de Base SJRP is CMS 95639. NCT overlap with this Brasília canonical string is 0. “Hospital de Base” in the name is not a merge key. Brasília versus São José do Rio Preto is the filter.

Is this Hospital de Base de São José do Rio Preto?

No. That is CMS 95639. NCT overlap with this Brasília string is 0. The prior Hospital de Base skip was SJRP-campus only. This page is Hospital de Base do Distrito Federal.

Why DEVICE n=1?

That is the ranking-table DEVICE count for this string. 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 NCT00294658?

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

Next step

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

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 Integral Pesquisa e Ensino Votuporanga as a bioaccess® client.

If you searched Integral Pesquisa e Ensino Votuporanga first-in-human, INTEGRAL Pesquisa Votuporanga clinical trial, Integral CRO Brazil, or “go direct Integral Pesquisa e Ensino Votuporanga,” you followed a campus string ClinicalTrials.gov still publishes. Integral Pesquisa e Ensino in Votuporanga, Brazil, 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 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 Votuporanga research center. It is not Centro de Pesquisa São Lucas Campinas (CMS 95689) and it is not Instituto de Pesquisa Clínica de Campinas (CMS 95715). Sharing a São Paulo-state research-center search is not a license to collapse them. Votuporanga is not Campinas. Casing alias INTEGRAL Pesquisa e Ensino 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• Integral Pesquisa e Ensino (Votuporanga, Brazil) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT03127631, NCT04844606, NCT05021835.
• Casing alias INTEGRAL Pesquisa e Ensino: ALL n=9. Listed separately. Same slug. We do not invent a unique-study union of 23+9. We do not ship a second slug for the capitals.

Cite canonical ALL n=23 and DEVICE n=0. Cite alias ALL n=9 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 center as a client site.

That is the leak: a founder searching “Integral Votuporanga first-in-human” or “INTEGRAL Pesquisa e Ensino clinical trial” finds canonical ALL n=23 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on São Lucas Campinas or IPECC. A named Votuporanga research center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

Integral Pesquisa e Ensino is a serious named Votuporanga research center on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into São Lucas Campinas or Instituto de Pesquisa Clínica de Campinas. 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 Integral Pesquisa e Ensino Votuporanga 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 Centro de Pesquisa São Lucas Campinas or Instituto de Pesquisa Clínica de Campinas?

No. São Lucas Campinas is CMS 95689. Instituto de Pesquisa Clínica de Campinas is CMS 95715. This page is Integral Pesquisa e Ensino, Votuporanga only. INTEGRAL ALL n=9 stays listed separately; we do not union.

Should I add canonical ALL n=23 and INTEGRAL ALL n=9?

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

Is this a Campinas research center?

No. Campinas siblings remain on their own slugs. Votuporanga is a different city and a different NCT string.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=23 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 NCT03127631?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Campinas siblings (do not merge): Centro de Pesquisa São Lucas Campinas, Instituto de Pesquisa Clínica de Campinas.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Pesquisare Saude Santo André first-in-human, Pesquisare Saúde clinical trial, Pesquisare CRO Brazil, or “go direct Pesquisare Saúde Santo André,” you followed a campus string ClinicalTrials.gov still publishes. Pesquisare Saude in Santo André, Brazil, is a real named research-site string on ClinicalTrials.gov. Same class as Clinstile and FAICIC. 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 site 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 site still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Santo André research site. It is not Faculdade de Medicina do ABC (CMS 95637). NCT overlap with FMABC on this canonical string is 2. Link it as a sibling; do not clone CMS 95637. It is not CEPHO Santo André (this batch, a different NCT string; overlap 0). Short alias Pesquisare and legal-suffix Pesquisare Saúde Sociedade Simples 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• Pesquisare Saude (Santo André, Brazil) — canonical NCT string: ALL interventional n=30; DEVICE n=0. Example NCT IDs: NCT03381196, NCT03466411, NCT03847090.
• Short alias Pesquisare: ALL n=10. Listed separately. Same slug. We do not invent a unique-study union of 30+10. We do not ship a second slug.
• Legal-suffix alias Pesquisare Saúde Sociedade Simples: ALL n=7. Listed separately. Same slug. No union. No second slug.

Cite canonical ALL n=30 and DEVICE n=0. Cite alias ALL n=10 and ALL n=7 separately. Do not add them. We will not invent a DEVICE n. Do not clone FMABC 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 site as a client site.

That is the leak: a founder searching “Pesquisare Santo André first-in-human” or “Pesquisare Saúde clinical trial” finds canonical ALL n=30 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on FMABC or CEPHO. A named research site is still a site. An NCT location row is not a CRO.

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

A named site 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 site 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 site 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 Pesquisare is not an FMABC file and is not a CEPHO 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 site

Pesquisare Saude is a serious named Santo André research site on the public registry. ALL n=30 is registry volume, not a punchline. Do not invent a DEVICE n. Do not clone FMABC. Do not merge it into CEPHO. 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 Pesquisare Saúde Santo André directly for a device FIH?

You can try. The site 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 site. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Faculdade de Medicina do ABC or CEPHO Santo André?

No. FMABC is CMS 95637 (NCT overlap 2 on this canonical string). Link it; do not merge it. CEPHO Santo André is a different organization on its own slug in this batch (overlap 0). Short ALL n=10 and Sociedade Simples ALL n=7 stay listed separately; we do not union.

Should I add canonical ALL n=30, short ALL n=10, and Sociedade Simples ALL n=7?

No. Alias n is listed separately. A unique-study union is not published. The short name and the legal suffix stay on this slug.

Is this Faculdade de Medicina do ABC?

No. FMABC is CMS 95637. Same city is not the same NCT string. NCT overlap is 2. We link that page as a sibling. We do not clone it.

Is this CEPHO Santo André?

No. CEPHO is a different named center on its own slug in this batch. Overlap with this canonical string is 0.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=30 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 NCT03381196?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Santo André sibling (do not merge): Faculdade de Medicina do ABC. CEPHO sibling in this batch: CEPHO Santo André.

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 INVIMA, 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 Oncomedica S.A. Montería as a bioaccess® client.

If you searched Oncomedica Montería first-in-human, Oncomedica S.A. clinical trial, Oncomedica CRO Colombia, or “go direct Oncomedica S.A. Montería,” you followed a campus string ClinicalTrials.gov still publishes. Oncomedica S.A. in Montería, Colombia, is a real named oncology-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns INVIMA, institutional ethics / CEI, 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 named Montería oncology clinic. It is not Hospital Pablo Tobón Uribe (CMS 95624) and it is not Hospital Universitario San Ignacio (CMS 95631). Sharing a Colombian NCT search is not a license to collapse them. Montería is not Medellín and is not Bogotá. Site-number Oncomedica S.A. strings stay 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 rows in /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• Oncomedica S.A. (Montería, Colombia) — canonical NCT string: ALL interventional n=22; DEVICE n=1. Example NCT IDs: NCT00542308, NCT00774345, NCT00910910.

Cite canonical ALL n=22 and DEVICE n=1. Site-number Oncomedica strings stay listed separately on this slug. We do not invent a unique-study union. We do not ship a second 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 clinic as a client site.

That is the leak: a founder searching “Oncomedica Montería first-in-human” or “Oncomedica S.A. clinical trial Colombia” finds canonical ALL n=22 (DEVICE n=1) without finding INVIMA, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Pablo Tobón Uribe or San Ignacio. A named Montería clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation in Montería is not a Pablo Tobón Uribe file and is not a San Ignacio 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 INVIMA actually works (the short version)

Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance.

Ask for a protocol-specific calendar. A hospital email is not INVIMA 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

Oncomedica S.A. is a serious named Montería oncology clinic on the public registry. ALL n=22 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into Pablo Tobón Uribe or San Ignacio. Do not invent a PI. Use the site when the protocol fits. Hire the operator. bioaccess® still runs clinical trials in Colombia.

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 INVIMA / 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 Oncomedica S.A. Montería 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 INVIMA 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 Hospital Pablo Tobón Uribe or Hospital Universitario San Ignacio?

No. Pablo Tobón Uribe is CMS 95624 in Medellín. San Ignacio is CMS 95631 in Bogotá. This page is Oncomedica S.A., Montería only. Site-number strings stay on this slug; we do not union.

Is this Hospital Pablo Tobón Uribe?

No. That is CMS 95624 in Medellín. Montería versus Medellín is the filter. A Colombian NCT string is not a merge key.

Is this Hospital Universitario San Ignacio?

No. That is CMS 95631 in Bogotá. This page is Oncomedica S.A. in Montería.

Why DEVICE n=1?

That is the ranking-table DEVICE count for this string. It is still not INVIMA authorization. Colombia ethics typically 4–6 weeks and per-patient $15,000–$25,000 on the published Panama comparison. We pick the country the device needs.

Did bioaccess® run NCT00542308?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia sibling (do not merge): Hospital Pablo Tobón Uribe. Panama comparison clocks: clinical trials in Panama.

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 CEMEDIC as a bioaccess® client.

If you searched CEMEDIC first-in-human, CEMEDIC CABA clinical trial, Centro de Especialidades Medicas Villa Luro CRO, or “go direct CEMEDIC,” you followed a campus string ClinicalTrials.gov still publishes. CEMEDIC in Buenos Aires, Argentina, is a real named specialty/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 specialty center. It is not Centro Médico Viamonte (CMS 95668), not CINME (CMS 95669), not CIPREC (CMS 95641), not Mautalen (CMS 95681), not Hospital Italiano de Buenos Aires (CMS 95620), and not Instituto Alexander Fleming (CMS 95708). Sharing Buenos Aires is not a license to collapse them. Aliases CEMEDIC CABA and CEMEDIC – Centro de Especialidades Medicas Villa Luro 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 /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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.

• CEMEDIC (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT02594371, NCT04036253, NCT04255433.
• City-label alias CEMEDIC (CABA): ALL n=10. Listed separately. Same slug. We do not invent a unique-study union of 22+10. We do not ship a second slug.
• Neighborhood alias CEMEDIC – Centro de Especialidades Medicas (Villa Luro): ALL n=9. Listed separately. Same slug. No union. No second slug.

Cite canonical ALL n=22 and DEVICE n=0. Cite CABA ALL n=10 and Villa Luro ALL n=9 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 center as a client site.

That is the leak: a founder searching “CEMEDIC first-in-human” or “CEMEDIC Villa Luro clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming. A named specialty center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at CEMEDIC is not a Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming 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 center

CEMEDIC is a serious named Buenos Aires specialty/research center on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming. 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 CEMEDIC 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 Viamonte, CINME, CIPREC, Mautalen, HIBA, or Instituto Alexander Fleming?

No. Viamonte is CMS 95668. CINME is CMS 95669. CIPREC is CMS 95641. Mautalen is CMS 95681. HIBA is CMS 95620. Fleming is CMS 95708. This page is CEMEDIC, Buenos Aires only. CABA ALL n=10 and Villa Luro ALL n=9 stay listed separately; we do not union.

Should I add canonical ALL n=22, CABA ALL n=10, and Villa Luro ALL n=9?

No. Alias n is listed separately. A unique-study union is not published. CABA and Villa Luro strings stay on this slug.

Is this CINME, CIPREC, Viamonte, or Mautalen?

No. Those are already-live Buenos Aires intercepts. This page is CEMEDIC only.

Is this Hospital Italiano or Instituto Alexander Fleming?

No. HIBA is CMS 95620. Fleming is CMS 95708. Sharing Buenos Aires is not a merge.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 is still not ANMAT authorization. A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. Trial versus registro remain different petitions.

Did bioaccess® run NCT02594371?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires siblings (do not merge): CINME, CIPREC, Centro Médico Viamonte, Instituto Alexander Fleming.

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 Alemán Buenos Aires as a bioaccess® client.

If you searched Hospital Aleman Buenos Aires first-in-human, Hospital Alemán CABA clinical trial, Hospital Alemán CRO Argentina, or “go direct Hospital Alemán Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Aleman in Buenos Aires, Argentina, 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 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 named Buenos Aires hospital. It is not Hospital Alemão Oswaldo Cruz (CMS 95635, São Paulo), not Hospital Italiano de Buenos Aires (CMS 95620), and not Hospital Británico (CMS 95654). Sharing “Alemán / Alemão” or sharing Buenos Aires is not a license to collapse them. City-label aliases Hospital Aleman Caba / CABA / Ciudad Autónoma stay 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 /workspace/five-trials/kill-page-batch-10-picks-2026-09-02.md 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 Aleman (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT00496002, NCT00496158, NCT00940095.
• City-label alias Hospital Aleman (Caba): ALL n=11. Listed separately. Same slug. No union.
• City-label alias Hospital Aleman (CABA): ALL n=10. Listed separately. Same slug. No union. A CABA DEVICE n=6 label is listed separately as well; we do not invent a unique-study union with canonical DEVICE n=0.

Cite canonical ALL n=22 and DEVICE n=0. Cite Caba ALL n=11 and CABA ALL n=10 separately. Do not add them. Ciudad Autónoma city-label strings stay on this slug. We do not clone CMS 95635.

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 Alemán Buenos Aires first-in-human” or “Hospital Aleman CABA clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Alemão Oswaldo Cruz, HIBA, or Británico. A named hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Hospital Alemán is not an Oswaldo Cruz São Paulo file, not a HIBA file, and not a Británico 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 hospital

Hospital Aleman is a serious named Buenos Aires hospital on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n for the canonical string. Do not merge it into Hospital Alemão Oswaldo Cruz, HIBA, or Británico. 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 Hospital Alemán 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.

Is this the same page as Hospital Alemão Oswaldo Cruz, Hospital Italiano de Buenos Aires, or Hospital Británico?

No. Hospital Alemão Oswaldo Cruz is CMS 95635 in São Paulo. HIBA is CMS 95620. Británico is CMS 95654. This page is Hospital Aleman, Buenos Aires only. Caba ALL n=11 and CABA ALL n=10 stay listed separately; we do not union.

Should I add canonical ALL n=22, Caba ALL n=11, and CABA ALL n=10?

No. Alias n is listed separately. A unique-study union is not published. Caba / CABA / Ciudad Autónoma city-label strings stay on this slug.

Is this Hospital Alemão Oswaldo Cruz?

No. That is CMS 95635 in São Paulo. German-hospital naming in another country is not a merge. Overlap on that live page is not a reason to clone it here.

Why DEVICE n=0 on the canonical string?

That is the ranking-table DEVICE count for Hospital Aleman, Buenos Aires. A separate CABA DEVICE n=6 label is listed separately; we do not union it onto canonical DEVICE n=0. ALL n=22 is still not ANMAT authorization. A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. Trial versus registro remain different petitions.

Did bioaccess® run NCT00496002?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires siblings (do not merge): Hospital Italiano de Buenos Aires, Hospital Británico. São Paulo sibling (do not merge): Hospital Alemão Oswaldo Cruz.

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 San Roque Tucumán as a bioaccess® client.

If you searched Centro Medico San Roque Tucuman first-in-human, San Roque San Miguel de Tucumán clinical trial, Centro Médico San Roque CRO, or “go direct Centro Médico San Roque Tucumán,” you followed a campus string ClinicalTrials.gov still publishes. Centro Medico San Roque in San Miguel de Tucumán, Argentina, is a real named private medical-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 Tucumán private medical center. It is not Centro de Investigaciones Médicas Tucumán (CMS 95682), not Hospital San Roque Córdoba (CMS 95686; NCT overlap 0), and not Centro Médico Privado de Reumatología Tucumán (batch 5, already live). Sharing Tucumán or sharing “San Roque” is not a license to collapse them. Córdoba is a different city.

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-10-picks-2026-09-02.md 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.

• Centro Medico San Roque (San Miguel de Tucumán, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT00388726, NCT00428220, NCT00465491.

Cite canonical ALL n=22 and DEVICE n=0. We will not invent an alias union with CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. We will not invent a DEVICE n. NCT overlap with Hospital San Roque Córdoba is 0.

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

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

That is the leak: a founder searching “Centro Médico San Roque Tucumán first-in-human” or “San Roque San Miguel de Tucumán clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. A named medical center is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Centro Médico San Roque is not a CIM Tucumán file, not a Hospital San Roque Córdoba file, and not a reumatología-Tucumán 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 center

Centro Medico San Roque is a serious named Tucumán private medical center on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. 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 San Roque Tucumán 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 CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán?

No. CIM Tucumán is CMS 95682. Hospital San Roque Córdoba is CMS 95686 (NCT overlap 0). Centro Médico Privado de Reumatología Tucumán is already live from batch 5. This page is Centro Medico San Roque, San Miguel de Tucumán only.

Is this Hospital San Roque Córdoba?

No. Hospital San Roque Córdoba is CMS 95686. NCT overlap with this Tucumán string is 0. “San Roque” in the name is not a merge key. Córdoba versus Tucumán is the filter.

Is this CIM Tucumán?

No. CIM Tucumán is CMS 95682. Same city is not the same NCT string.

Is this Centro Médico Privado de Reumatología Tucumán?

No. That intercept is already live from batch 5. This page is Centro Medico San Roque.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 is still not ANMAT authorization. A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. Trial versus registro remain different petitions.

Did bioaccess® run NCT00388726?

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

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Tucumán siblings (do not merge): CIM Tucumán, Centro Médico Privado de Reumatología Tucumán. Córdoba sibling: Hospital San Roque Córdoba.

Julio G. Martinez-Clark, CEO · bioaccess®