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

If you searched CEPHO Santo André first-in-human, Centro de Estudos e Pesquisas de Hematologia e Oncologia clinical trial, CEPHO CRO, or “go direct CEPHO Santo André,” you followed a campus string ClinicalTrials.gov still publishes. CEPHO – Centro de Estudos e Pesquisas de Hematologia e Oncologia in Santo André, Brazil, is a real named hematology/oncology 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 CEPHO Santo André center. It is not Faculdade de Medicina do ABC and it is not Pesquisare Saúde (separate page). NCT overlap with both canonical strings is 0. Sharing Santo André is not a license to collapse them. Preposition alias CEPHO – Centro de Estudos e Pesquisas em Hematologia e Oncologia stays on this page; we do not ship a second page.

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

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

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

• CEPHO – Centro de Estudos e Pesquisas de Hematologia e Oncologia (Santo André, Brazil) — canonical NCT string: ALL interventional n=21; DEVICE n=0. Example NCT IDs: NCT03088813, NCT03523585, NCT03529110.
• Preposition alias CEPHO – Centro de Estudos e Pesquisas em Hematologia e Oncologia: ALL n=8. Listed separately. Same page. We do not invent a combined unique-study total of 21+8. We do not ship a second page for “em” versus “de.”

These counts are not added together. We will not invent a DEVICE n.

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

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

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

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Not a critique of the center

CEPHO is a serious named Santo André hematology/oncology research center on the public registry. ALL n=21 is registry volume, not a punchline. It is separate from FMABC or Pesquisare. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract CEPHO Santo André directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. FMABC has its own page (overlap 0). Pesquisare is a different organization (overlap 0). This page is CEPHO Santo André only. “Em” ALL n=8 stays listed separately; we do not combine them.

Should I add canonical ALL n=21 and “em” ALL n=8?

No. Alias n is listed separately. A combined unique-study total is not published. “Em” versus “de” is the same CEPHO campus on the same page.

Is this FMABC or Pesquisare?

No. Same city is not the same NCT string. Overlap with both canonical strings 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=21 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 NCT03088813?

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. Santo André siblings (do not merge): Faculdade de Medicina do ABC, Pesquisare Saúde.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Biomedica Research Group Santiago first-in-human, BioMedica Research Group Chile clinical trial, Biomedica CRO Chile, or “go direct Biomedica Research Group Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Biomedica Research Group in Santiago, Chile, is a real named research-group 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 ISP file.

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

This page is the named Santiago research-group row. It is not Hospital Clínico Universidad Católica, not Hospital Clínico Universidad de Chile, not Universidad Andrés Bello, not FALP, and not Club de Leones Cruz del Sur. Sharing Santiago is not a license to collapse them. Punta Arenas is not this campus. Casing alias BioMedica Research Group stays on this page; we do not ship a second page.

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

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

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

• Biomedica Research Group (Santiago, Chile) — canonical NCT string: ALL interventional n=21; DEVICE n=0. Example NCT IDs: NCT01224106, NCT01371708, NCT01371734.
• Casing alias BioMedica Research Group: ALL n=7. Listed separately. Same page. We do not invent a combined unique-study total of 21+7. We do not ship a second page for the capital M.

These counts are not added together. We will not invent a DEVICE n. We will not invent PAHO/WHO Level 4 standing for ISP.

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

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

That is the leak: a founder searching “Biomedica Research Group Santiago first-in-human” or “BioMedica Chile clinical trial” finds canonical ALL n=21 (DEVICE n=0) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Católica, UChile, UNAB, FALP, or Club de Leones. A named research group is still a site. An NCT location row is not a CRO.

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

A named group 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 group 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 group is not built to own for an investigational device:

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

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

How ISP actually works (the short version)

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

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

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

Not a critique of the group

Biomedica Research Group is a serious named Santiago research group on the public registry. ALL n=21 is registry volume, not a punchline. We do not invent PAHO/WHO Level 4 for ISP. It is separate from Católica, UChile, UNAB, FALP, or Club de Leones. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Biomedica Research Group Santiago directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Católica, UChile, UNAB, FALP, or Club de Leones Cruz del Sur?

No. Católica has its own page. UChile has its own page. UNAB has its own page. FALP has its own page. Club de Leones has its own page (Punta Arenas). This page is Biomedica Research Group, Santiago only. BioMedica ALL n=7 stays listed separately; we do not combine them.

Should I add canonical ALL n=21 and BioMedica ALL n=7?

No. Alias n is listed separately. A combined unique-study total is not published. The capital M is the same Santiago campus on the same page.

Is this FALP or a Santiago university hospital?

No. FALP has its own page. Católica has its own page. UChile has its own page. UNAB has its own page. This page is Biomedica Research Group only.

Does ISP have PAHO/WHO Level 4 standing?

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

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=21 is still not ISP authorization.

Did bioaccess® run NCT01224106?

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

Next step

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

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 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, not UNIFESP, and not University of Campinas / UNICAMP. 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 page; we do not ship second pages. UNESP Presidente Prudente or Araraquara strings are other campuses, not this row and not a second page.

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

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

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

• 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 page. No combined total.
• Alias Faculdade de Medicina da UNESP: ALL n=8. Listed separately. Same page. No combined total.

Alias counts are listed separately. The 22+8+8 counts are not added together. We will not invent a DEVICE n.

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

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this 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 in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

Not a critique of the 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. It is separate from USP, UNIFESP, or UNICAMP. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract 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 answers the search; it does not claim the studies.

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

No. USP has its own page. UNIFESP has its own page. UNICAMP has its own page. This page is UNESP Faculdade de Medicina Campus Botucatu only. Alias ALL n=8 and ALL n=8 stay listed separately; we do not combine them. Other UNESP cities are not this row and not a second page.

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

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

Is this USP, UNIFESP, or UNICAMP?

No. Those are already-live university pages. 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. NCT overlap with IBPClin – Instituto Brasil de Pesquisa Clínica is 6 on this canonical string. It is not Universidade Federal do Rio de Janeiro. Legal-suffix alias Ruschel Medicina e Pesquisa Clínica Ltda stays on this page; we do not ship a second page.

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

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

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

• 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 page. We do not invent a combined unique-study total of 22+7. We do not ship a second page for Ltda.

These counts are not added together. We will not invent a DEVICE n.

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

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this 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 in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

Not a critique of the 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. It is separate from UFRJ. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract 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 answers the search; it does not claim the studies.

Is this the same page as IBPClin or Universidade Federal do Rio de Janeiro?

No. IBPClin has its own page — a different organization (NCT overlap 6 on this canonical string). UFRJ has its own page. This page is Ruschel Medicina e Pesquisa Clínica only. Ltda ALL n=7 stays listed separately; we do not combine them.

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

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

Is this IBPClin?

No. IBPClin has its own page. NCT overlap is 6. We link that page as a sibling.

Is this UFRJ?

No. Universidade Federal do Rio de Janeiro has its own page. 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 and Instituto de Investigaciones Clínicas Mar del Plata. It is not Instituto de Oncología de Rosario, not Hospital Provincial del Centenario, and not INECO Neurociencias Oroño. Sharing Rosario or sharing an IIC token is not a license to collapse them. Alias Instituto de Investigaciones Clinicas de Rosario stays on this page; we do not ship a second page.

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

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

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

• 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 page. We do not invent a combined unique-study total of 22+10. We do not ship a second page for the extra “de.”

These counts are not added together. 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.

Not a critique of 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. It is separate from Oncología Rosario, Centenario, INECO, IIC Quilmes, or IIC Mar del Plata. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract 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 answers 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 has its own page (NCT overlap 0). Centenario has its own page. INECO has its own page. IIC Quilmes has its own page. IIC Mar del Plata has its own page. This page is Instituto de Investigaciones Clinicas Rosario only. “De Rosario” ALL n=10 stays listed separately; we do not combine them.

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

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

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

No. Oncología Rosario has its own page (overlap 0). IIC Quilmes has its own page. IIC Mar del Plata has its own page. 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. 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 page; we do not ship a second page.

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

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

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

• Hospital de Base do Distrito Federal (Brasília, Brazil) — canonical NCT string: ALL interventional n=22; DEVICE n=1. Example NCT IDs: NCT00294658, NCT00905905, NCT00906451.

We will not invent a combined alias count with FAMERP / Hospital de Base SJRP. Instituto Hospital de Base do Distrito Federal stays on this page, not a second page.

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

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

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

Not a critique of the hospital

Hospital de Base 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. It is separate from FAMERP or Hospital de Base SJRP. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital 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 answers 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 has its own page. 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 FAMERP São José do Rio Preto. 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 and it is not Instituto de Pesquisa Clínica de Campinas. 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 page; we do not ship a second page.

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

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

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

• 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 page. We do not invent a combined unique-study total of 23+9. We do not ship a second page for the capitals.

These counts are not added together. We will not invent a DEVICE n.

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

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

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

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

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

Not a critique of the center

Integral Pesquisa e Ensino is a serious named Votuporanga research center on the public registry. ALL n=23 is registry volume, not a punchline. It is separate from São Lucas Campinas or Instituto de Pesquisa Clínica de Campinas. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract 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 answers 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 has its own page. Instituto de Pesquisa Clínica de Campinas has its own page. This page is Integral Pesquisa e Ensino, Votuporanga only. INTEGRAL ALL n=9 stays listed separately; we do not combine them.

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

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

Is this a Campinas research center?

No. Campinas siblings remain on their own pages. 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. NCT overlap with FMABC on this canonical string is 2. It is not CEPHO Santo André (separate page, a different NCT string; overlap 0). Short alias Pesquisare and legal-suffix Pesquisare Saúde Sociedade Simples stay on this page; we do not ship second pages.

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

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

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

• 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 page. We do not invent a combined unique-study total of 30+10. We do not ship a second page.
• Legal-suffix alias Pesquisare Saúde Sociedade Simples: ALL n=7. Listed separately. Same page. No combined total. No second page.

These counts are not added together. We will not invent a DEVICE n.

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

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this 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 in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

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

Not a critique of the site

Pesquisare Saude is a serious named Santo André research site on the public registry. ALL n=30 is registry volume, not a punchline. It is separate from CEPHO. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract 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 answers 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 has its own page (NCT overlap 2 on this canonical string). CEPHO Santo André is a different organization (overlap 0). Short ALL n=10 and Sociedade Simples ALL n=7 stay listed separately; we do not combine them.

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

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

Is this Faculdade de Medicina do ABC?

No. FMABC has its own page. Same city is not the same NCT string. NCT overlap is 2. We link that page as a sibling.

Is this CEPHO Santo André?

No. CEPHO is a different named center. 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: 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 and it is not Hospital Universitario San Ignacio. 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 page; we do not ship a second page.

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

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

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

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

Site-number Oncomedica strings stay listed separately on this page. We do not invent a combined unique-study total. We do not ship a second page.

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.

Not a critique of 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. It is separate from Pablo Tobón Uribe or San Ignacio. 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 in 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 answers 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 has its own page in Medellín. San Ignacio has its own page in Bogotá. This page is Oncomedica S.A., Montería only. Site-number strings stay on this page; we do not combine them.

Is this Hospital Pablo Tobón Uribe?

No. That is Hospital Pablo Tobón Uribe 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 Hospital Universitario San Ignacio 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®