Category: Navigating Regulatory Landscapes in Latin America

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

If you searched FAMERP first-in-human, Fundação Faculdade Regional de Medicina de São José do Rio Preto clinical trial, FAMERP CRO Brazil, or “go direct FAMERP São José do Rio Preto,” you followed a campus string ClinicalTrials.gov still publishes. Fundação Faculdade Regional de Medicina de São José do Rio Preto (FAMERP) in São José do Rio Preto, Brazil, is a real campus string on ClinicalTrials.gov. It is not a São Paulo capital hospital. 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 São José do Rio Preto FAMERP intercept. Distinct from University of Sao Paulo (CMS 95616), Hospital das Clínicas FMUSP (CMS 95630), ICESP (this batch), UNIFESP (CMS 95632), and Barretos Cancer Hospital (this batch). Different cities or different NCT strings. Do not collapse interior São Paulo state into the capital because both appear on a LATAM ranking.

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:

• Fundação Faculdade Regional de Medicina de São José do Rio Preto (São José do Rio Preto, Brazil): ALL interventional n=61 (rank 11). Example NCT IDs: NCT01972568, NCT01997229, NCT02145611.

Cite ALL only as given for this string. We will not invent a DEVICE n that the dump did not publish for this row.

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 “FAMERP clinical trial” or “São José do Rio Preto FIH” finds rank 11 on the ALL list (n=61) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on USP, HCFMUSP, ICESP, UNIFESP, or Barretos. Registry volume in the interior is still not a CRO product, and not a claim that bioaccess® ran any of those IDs.

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

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

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

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and 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 in São José do Rio Preto is not that dossier, and it is not a USP or ICESP file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-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.

Site versus CRO

Workstream	What FAMERP (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One São José do Rio Preto campus string — not USP, HCFMUSP, ICESP, UNIFESP, or Barretos	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

FAMERP is a serious academic resource in São José do Rio Preto. Rank 11 on ALL (n=61) is registry volume, not a punchline. Do not merge it into USP, HCFMUSP, ICESP, UNIFESP, or Barretos. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract FAMERP São José do Rio Preto directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as USP, HCFMUSP, ICESP, UNIFESP, or Barretos?

No. USP is CMS 95616. HCFMUSP is CMS 95630. UNIFESP is CMS 95632. ICESP and Barretos are separate intercepts in this batch. This page is Fundação Faculdade Regional de Medicina de São José do Rio Preto / FAMERP only.

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

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

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

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

Is São José do Rio Preto the same metro as ICESP or HCFMUSP?

No. ICESP and Hospital das Clínicas FMUSP sit on São Paulo capital strings. FAMERP is a São José do Rio Preto string. City fields on ClinicalTrials.gov are not a license to merge campuses.

Does rank 11 ALL mean this campus is already a device FIH operator?

No. Rank is unique NCT IDs on one facility string. Combined ethics + ANVISA still typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. An ALL ranking does not write that dossier.

Next step

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

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 Universitario Austral as a bioaccess® client.

If you searched Hospital Universitario Austral first-in-human, Austral Pilar clinical trial, HUA CRO Argentina, or “go direct Hospital Universitario Austral,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario Austral in Pilar, Argentina, is a real university hospital. 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 Pilar campus intercept. It does not clone Hospital Italiano de Buenos Aires (CMS 95620), Sagrada Familia / ENERI (CMS 95625), or Hospital Italiano Asunción (CMS 95517). Different cities. Different NCT strings. Asunción is a different country and a different regulator (DINAVISA).

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

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

• Hospital Universitario Austral (Pilar, Argentina): ALL interventional n=52 (rank 22). Sponsor class: INDUSTRY:49; OTHER:3. Example NCT IDs: NCT00057720, NCT00411385, NCT00443118.

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 Universitario Austral clinical trial” or “Austral Pilar FIH” finds rank 22 on ALL (n=52) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA or Asunción Italiano, which are different files.

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 in Pilar is not that 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.

Site versus CRO

Workstream	What Hospital Universitario Austral (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Pilar campus string — not HIBA, not ENERI, not Asunción Italiano	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Universitario Austral is a serious Pilar academic resource. n=52 ALL is registry volume, not a punchline. Do not merge it into Hospital Italiano de Buenos Aires or into Asunción. Trial authorization and registro remain separate ANMAT petitions.

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 Universitario Austral directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Italiano de Buenos Aires, ENERI, or Hospital Italiano Asunción?

No. HIBA is CMS 95620. Sagrada Familia / ENERI is CMS 95625. Asunción Italiano is CMS 95517 (DINAVISA, Paraguay). This page is Hospital Universitario Austral in Pilar only.

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

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

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

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

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

No. It is a published statutory target on the trial-authorization side and the clock pauses for RFIs. Trial versus registro are separate. Ask for a protocol-specific calendar. An NCT row is not ANMAT clearance.

Does INDUSTRY:49 mean bioaccess® ran those studies?

No. That is the ALL-row sponsor-class split. No public bioaccess® case-study page names this hospital. We will not invent a PI or a client claim.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Faculdade de Medicina do ABC first-in-human, FMABC clinical trial, Medicina do ABC Santo André CRO, or “go direct Faculdade de Medicina do ABC,” you followed a campus string ClinicalTrials.gov still publishes. Faculdade de Medicina do ABC in Santo André, São Paulo state, is a real medical school / campus string on ClinicalTrials.gov. Santo André is a different city from São Paulo proper. 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 Santo André FMABC intercept. It is not USP, not UNIFESP, and not UNINOVE. Different cities or different NCT strings. Do not collapse ABC into a São Paulo university because the metro area is large.

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:

• Faculdade de Medicina do ABC (Santo André, Brazil): ALL interventional n=67 (rank 8). Sponsor class: INDUSTRY:59; OTHER:8. Example NCT IDs: NCT00036647, NCT00337103, NCT00582426.

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 “Faculdade de Medicina do ABC clinical trial” or “FMABC FIH” finds rank 8 on the ALL list (n=67) without finding ANVISA, import, insurance, or 21 CFR 812.28. INDUSTRY:59 is registry sponsor class, not a bioaccess® client list. We cite ALL only as given for this string.

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. A hallway conversation in Santo André is not that dossier, and it is not a USP or UNIFESP 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.

Site versus CRO

Workstream	What FMABC (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Santo André campus string — not USP, UNIFESP, or UNINOVE	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Faculdade de Medicina do ABC is a serious academic resource in Santo André. Rank 8 on ALL (n=67) is registry volume, not a punchline. High industry share is still not a device-CRO quality system. Do not merge ABC into USP, UNIFESP, or UNINOVE.

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 Faculdade de Medicina do ABC directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. USP is CMS 95616 (São Paulo). UNIFESP is a separate intercept in this batch. UNINOVE is CMS 95619. This page is Faculdade de Medicina do ABC in Santo André only.

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

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

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

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

Is Santo André the same city as the USP campus?

No. The ranking prints city Santo André for this string. University of Sao Paulo and UNIFESP print São Paulo. Different city field. Different NCT string. Do not merge them.

Does rank 8 ALL mean this is the top Brazilian device site?

No. This citation is ALL interventional. We are not inventing a DEVICE n that the dump did not give us for this string. Ranking is not a bioaccess® study claim.

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. Sibling São Paulo NCT string: University of Sao Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Sao Lucas PUCRS first-in-human, Hospital São Lucas da PUCRS clinical trial, São Lucas Porto Alegre CRO, or “go direct Hospital São Lucas da PUCRS,” you followed a campus string ClinicalTrials.gov still publishes. Hospital São Lucas da PUCRS in Porto Alegre is a real university hospital. ClinicalTrials.gov stores more than one spelling. 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 one intercept for two ALL spellings of the same campus. It does not clone Hospital de Clínicas de Porto Alegre (CMS 95615), Fundação Universitaria de Cardiologia (CMS 95612), or Hospital Moinhos de Vento (CMS 95622). Three (plus) Porto Alegre buildings. Three (plus) queries. List both strings; do not add the n’s as unique studies.

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:

• ALL: Hospital Sao Lucas – PUCRS (Porto Alegre, Brazil): n=56 (rank 14). Example NCT IDs: NCT00080340, NCT00413218, NCT00430352.
• ALL: Hospital São Lucas da PUCRS: n=56 (rank 15). Example NCT IDs: NCT00428220, NCT00430716, NCT00752362.

Two strings. Two ranks. Do not publish n=112 as if they were unique studies.

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 “São Lucas PUCRS clinical trial” finds two ALL spellings of one Porto Alegre campus without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, FUC, or Moinhos.

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. A hallway conversation at São Lucas is not that dossier, and it is not an HCPA 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.

Site versus CRO

Workstream	What São Lucas PUCRS (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	Two NCT spellings of one Porto Alegre campus; not HCPA, FUC, or Moinhos	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Hospital São Lucas da PUCRS is a serious academic resource. n=56 on each spelling is registry volume, not a punchline and not a unique-n total of 112. Do not merge Porto Alegre buildings. 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 São Lucas da PUCRS directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as HCPA, FUC, or Moinhos de Vento?

No. HCPA is CMS 95615. FUC is CMS 95612. Moinhos is CMS 95622. This page is Hospital São Lucas da PUCRS / Hospital Sao Lucas – PUCRS only.

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

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

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

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

Why merge two names onto one page?

Because they are accent and punctuation aliases of one campus. ClinicalTrials.gov counted them separately (rank 14 and rank 15, both n=56). Sponsors search both. One slug. We do not add the n’s.

Is this the same as Hospital de Clínicas de Porto Alegre?

No. HCPA is a different university hospital already intercepted. Porto Alegre has multiple buildings. An NCT city field is not a license to collapse them.

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. Porto Alegre siblings: HCPA, FUC, Moinhos de Vento. Country: clinical trials in Brazil.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Alemao Oswaldo Cruz first-in-human, Hospital Alemão Oswaldo Cruz clinical trial, HAOC CRO São Paulo, or “go direct Hospital Alemão Oswaldo Cruz,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Alemão Oswaldo Cruz in São Paulo is a real private hospital. ClinicalTrials.gov stores the facility string as Hospital Alemao Oswaldo Cruz. 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 Oswaldo Cruz campus intercept. It does not clone Einstein, HCFMUSP, HCor, Santa Marcelina, or Dante. Different buildings. Different NCT strings. We cite the ALL ranking only: the 1 September 2026 dump had no DEVICE row for this string, and we will not invent one.

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

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

• Hospital Alemao Oswaldo Cruz (São Paulo, Brazil): ALL interventional n=60 (rank 12). Sponsor class: INDUSTRY:58; OTHER:2. Example NCT IDs: NCT00346216, NCT00413699, NCT00617773.

Cite ALL only. There was no DEVICE row in the dump.

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 “Oswaldo Cruz clinical trial São Paulo” finds an industry-heavy ALL campus (n=60, rank 12) without finding ANVISA, import, insurance, or 21 CFR 812.28. INDUSTRY:58 is registry sponsor class, not a bioaccess® client list, and not proof the hospital is your FIH operator.

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. A hallway conversation at Hospital Alemão Oswaldo Cruz is not that dossier. An ALL-interventional ranking is not a device dossier either.
• 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.

Site versus CRO

Workstream	What Hospital Alemão Oswaldo Cruz (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One São Paulo hospital ALL string (no DEVICE row in the dump)	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Hospital Alemão Oswaldo Cruz is a serious São Paulo hospital. Rank 12 on ALL (n=60) is registry volume, not a punchline. High industry share is still not a device-CRO quality system. Do not invent a DEVICE n. Do not merge this campus into Einstein or HCFMUSP.

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 Alemão Oswaldo Cruz directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Einstein or HCFMUSP?

No. Einstein is a separate São Paulo intercept. Hospital das Clínicas FMUSP is a separate string in this batch. This page is Hospital Alemão Oswaldo Cruz / Hospital Alemao Oswaldo Cruz only.

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

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

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

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

Why no DEVICE n?

The 1 September 2026 LATAM dump did not include a DEVICE row for this facility string. We cite ALL n=60 (rank 12) only. We will not invent a device count.

Does INDUSTRY:58 mean this hospital is a CRO?

No. That is the sponsor-class split on the ALL row. It is not an operator claim and not a bioaccess® client list.

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. Einstein sibling: Hospital Israelita Albert Einstein.

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 Santa Marcelina as a bioaccess® client.

If you searched Hospital Santa Marcelina first-in-human, Santa Marcelina São Paulo clinical trial, Santa Marcelina CRO, or “go direct Hospital Santa Marcelina,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Santa Marcelina in São Paulo is a real hospital. 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 Santa Marcelina campus intercept. It does not clone Einstein, HCor, Hospital das Clínicas FMUSP, or Dante Pazzanese. Different buildings. Different NCT strings.

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

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

• Hospital Santa Marcelina (São Paulo, Brazil): DEVICE n=5 (rank 40). Sponsor class: INDUSTRY:4; OTHER:1. Example DEVICE NCT IDs: NCT00752362, NCT00917163, NCT01093391.
• ALL interventional: n=44 (rank 28).

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

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

That is the leak: a founder searching “Santa Marcelina clinical trial” finds a DEVICE campus string without finding ANVISA, import, insurance, or 21 CFR 812.28. Ranking n=5 DEVICE / n=44 ALL is registry volume, not a merged Einstein or HCFMUSP identity.

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. A hallway conversation at Santa Marcelina is not that dossier.
• 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.

Site versus CRO

Workstream	What Santa Marcelina (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One São Paulo hospital NCT string	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Hospital Santa Marcelina is a serious São Paulo resource. n=5 DEVICE and n=44 ALL are registry volume. Do not merge it into Einstein, HCor, HCFMUSP, or Dante. 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 Santa Marcelina directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Einstein, HCor, HCFMUSP, or Dante?

No. Einstein, InCor/HCFMUSP, and Dante already have live intercepts. HCor is a separate Hospital do Coracao intercept in this batch. This page is Santa Marcelina only.

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

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

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

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

Does INDUSTRY:4 on the DEVICE row mean bioaccess® ran those studies?

No. INDUSTRY:4; OTHER:1 is the ranking split. No public bioaccess® case-study page names this hospital. We will not invent that claim or a PI.

Is Santa Marcelina part of FMUSP?

No. Hospital das Clínicas FMUSP is a different NCT string and a different intercept. Do not collapse São Paulo hospitals because they share a city.

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. São Paulo siblings: Einstein, InCor.

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 do Coração (HCor) as a bioaccess® client.

If you searched Hospital do Coracao first-in-human, HCor São Paulo clinical trial, Hospital do Coração CRO, or “go direct Hospital do Coração (HCor),” you followed a campus string ClinicalTrials.gov still publishes. Hospital do Coração in São Paulo is a real private hospital. ClinicalTrials.gov stores the facility string as Hospital do Coracao (unaccented). 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 HCor campus intercept. It is not Instituto do Coração / InCor / HCFMUSP. Different building. Different NCT string. Heart-institute searches already have a live intercept: InCor HCFMUSP (CMS 95522). Link that page. Do not clone it. Do not copy Cephea or Leaflex claims onto HCor. We will not invent a CRO name from this ranking row.

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

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

• Hospital do Coracao (São Paulo, Brazil): DEVICE n=5 (rank 37). Sponsor class: OTHER:5. Example NCT IDs: NCT02232919, NCT03643939, NCT04253405.

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

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the 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 do Coração clinical trial” or “HCor FIH” finds a DEVICE campus string and may confuse it with InCor. Ranking n=5 DEVICE (OTHER:5) is registry volume, not InCor, and not a CRO we invent.

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. A hallway conversation at HCor is not that dossier, and it is not an InCor 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.

Site versus CRO

Workstream	What HCor (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Hospital do Coracao NCT string — not InCor	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Hospital do Coração is a serious São Paulo hospital. n=5 DEVICE is registry volume, not a punchline. Do not smear HCor by collapsing it into InCor. Do not smear InCor by copying its public device rows here. 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 do Coração (HCor) directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as InCor / Instituto do Coração HCFMUSP?

No. InCor is CMS 95522. This page is Hospital do Coracao / HCor only. Different building. We will not invent a CRO on this row, and we will not copy InCor studies.

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

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

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

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

The ranking says OTHER:5. Is that a named CRO?

No. OTHER:5 is the ClinicalTrials.gov sponsor-class split. We will not invent a CRO from that token. We will not invent a PI.

Why is there no ALL n?

Because the 1 September 2026 dump did not publish an ALL interventional row for this string. We will not invent one.

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. InCor sibling: InCor HCFMUSP. Country: clinical trials in Brazil.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Universidade Federal de São Paulo first-in-human, UNIFESP clinical trial, Federal University of Sao Paulo CRO, or “go direct Universidade Federal de São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Universidade Federal de São Paulo (UNIFESP) in São Paulo is a real federal university. ClinicalTrials.gov stores more than one spelling. 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 merges three NCT spellings of one campus for search intercept only. We do not claim a unique-study union and we do not add the n’s. It does not merge University of Sao Paulo (CMS 95616), Hospital das Clínicas FMUSP (this batch’s FMUSP page), UNINOVE (CMS 95619), or UFPE (CMS 95618). Different strings. Different queries.

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:

• DEVICE: Universidade Federal de São Paulo (São Paulo, Brazil): n=6 (rank 29). Example NCT IDs: NCT01276873, NCT01437553, NCT02579200.
• ALL: Federal University of Sao Paulo (no accent): n=55 (rank 17). Example NCT IDs: NCT00409955, NCT00491712, NCT00492245.
• ALL: Federal University of São Paulo (accent): n=49 (rank 25). Example NCT IDs: NCT00441181, NCT00827528, NCT00832897.

List each string’s n. Do not add 6+55+49 as if they were unique studies. Accent and English aliases are how the registry counted; they are not three hospitals.

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 “UNIFESP clinical trial” or “Federal University of Sao Paulo FIH” finds three spellings of one campus without finding ANVISA, import, insurance, or 21 CFR 812.28. We intercept all three on one slug. We do not invent a fourth university.

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. A campus email in Vila Clementino is not that dossier.
• 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.

Site versus CRO

Workstream	What UNIFESP campus strings (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	Three NCT spellings of one São Paulo campus; not a unique-n union	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

UNIFESP is a serious federal university. Separate n’s on three spellings are registry bookkeeping, not a punchline and not a unique-study total. Do not merge this campus into USP, HCFMUSP, UNINOVE, or UFPE.

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 Universidade Federal de São Paulo directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as University of Sao Paulo, HCFMUSP, UNINOVE, or UFPE?

No. USP is CMS 95616. HCFMUSP is the Hospital das Clínicas FMUSP intercept in this batch. UNINOVE is CMS 95619. UFPE is CMS 95618 (Pernambuco). This page is UNIFESP / Federal University of Sao Paulo aliases only.

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

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

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

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

Why merge three names, and is this USP?

Accent and language aliases of one campus; one slug; no unique-n total. University of Sao Paulo is CMS 95616 — a different string family. Federal versus state naming is not a license to collapse them.

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. Sibling São Paulo NCT string: University of Sao Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Universitario San Ignacio first-in-human, San Ignacio Bogotá clinical trial, HUSI CRO Colombia, or “go direct Hospital Universitario San Ignacio,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario San Ignacio in Bogotá is a real university hospital. 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 hospital 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the Bogotá San Ignacio campus intercept. It does not clone Fundación Santa Fe de Bogotá. Santa Fe is a different Bogotá building and a different NCT string. Linking is correct. Cloning that page is not.

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

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

• Hospital Universitario San Ignacio (Bogotá, Colombia): DEVICE n=6 (rank 26). Example DEVICE NCT IDs: NCT03084081, NCT03569254, NCT03570775.
• ALL interventional: n=47 (rank 26). ALL also lists NCT00545740, NCT00737529, NCT00950300.

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 “San Ignacio clinical trial Bogotá” finds a university hospital without finding INVIMA, import, insurance, or 21 CFR 812.28. Ranking n=6 DEVICE / n=47 ALL is registry volume, not a CRO product, and not a Santa Fe clone.

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

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

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

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and 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:

• 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 in Bogotá 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 FIH.
• 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.

Site versus CRO

Workstream	What San Ignacio (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	INVIMA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Bogotá university-hospital NCT string	Other Colombian sites and the rest of the bioaccess® platform

How INVIMA actually works (the short version)

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 near the 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 FIH.

Use CRO in Colombia and clinical-trials-colombia. INVIMA is published there as a PAHO/WHO Level 4 authority. 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 Colombian entity, INVIMA clocks in-country.

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

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

Do not smear the hospital

Hospital Universitario San Ignacio is a serious Bogotá academic resource. n=47 ALL is registry volume. It is not a device-CRO quality system. Do not merge it into Fundación Santa Fe. bioaccess® still runs clinical trials in Colombia through a local Colombian entity; that is the operator layer, not a claim that we run this hospital.

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 Hospital Universitario San Ignacio 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 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 hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. Registry ranking is not a bioaccess® claim that we ran the studies. Public NCT ranking only, from the 1 September 2026 6:32 PM ET API file.

Is this the same page as Fundación Santa Fe de Bogotá?

No. Santa Fe is a separate Bogotá intercept. This page is Hospital Universitario San Ignacio only.

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

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

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

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

Is INVIMA slower than Panama ethics?

The published comparison already on the Panama country page is Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K. We pick the country the device needs. Ranking San Ignacio high on ALL is not a reason to skip INVIMA or to skip Colombia.

Does “local Colombian entity” mean the hospital is the applicant?

No. bioaccess®’s local Colombian entity is the operator stack. The hospital remains the site. An NCT location row does not make San Ignacio the INVIMA applicant.

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 Colombia. Santa Fe sibling: Fundación Santa Fe de Bogotá FIH.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital das Clínicas FMUSP first-in-human, HCFMUSP clinical trial, Hospital das Clinicas Faculdade de Medicina USP CRO, or “go direct Hospital das Clínicas FMUSP,” you followed a campus string ClinicalTrials.gov still publishes. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo is a real university-hospital complex in São Paulo. The Brazil country page already notes it as one of the largest medical complexes in Latin America as a landscape fact; bioaccess® does not operate that hospital. 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 answers the NCT string Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo only. Distinct from University of Sao Paulo (CMS 95616), which already carved this complex out, and from InCor HCFMUSP (CMS 95522). Do not clone either. Do not copy heart-institute device claims here. University of Sao Paulo General Hospital is a different NCT string (DEVICE n=7, rank 24) — unmerged, same rule as 95616.

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

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

• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (São Paulo, Brazil): DEVICE n=7 (rank 22). Sponsor class: OTHER:5; INDUSTRY:2. Example DEVICE NCT IDs: NCT00254683, NCT00975741, NCT02179320.
• ALL interventional: n=45 (rank 27). ALL also lists NCT01145170 among its example IDs (with the DEVICE examples above).

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 “HCFMUSP clinical trial” finds a campus without finding ANVISA, import, insurance, or 21 CFR 812.28. n=7 DEVICE / n=45 ALL is registry volume, not InCor.

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 on the FMUSP campus is not that dossier.
• 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.

Site versus CRO

Workstream	What HCFMUSP / FMUSP hospital (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANVISA clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One FMUSP hospital NCT string (not InCor, not the English USP string)	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA and CEP actually work (the short version)

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

• Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023.
• Ethics committees (CEPs) are capped at 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have this campus” still leaves the packet to write.
• Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
• For early feasibility studies not intended for Brazilian market clearance, only institutional CEP approval is required — no CONEP review for most investigations under Law 14874.
• Trial authorization and later ANVISA market registration (RDC 751/2022 / BRH) are separate workstreams.
• Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A hospital or university email is not an ANVISA approval. bioaccess® manages the dossier in Portuguese. That is CRO work, not site work.

All bioaccess® Brazil device protocols 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.

Do not smear the hospital

Hospital das Clínicas FMUSP is a serious academic resource. n=7 DEVICE / n=45 ALL is registry volume, not a punchline. Use the site when it fits. Hire the operator. Do not merge into USP (95616), General Hospital, InCor (95522), Dante, Einstein, Santa Marcelina, HCor, or UNIFESP.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital das Clínicas FMUSP directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as University of Sao Paulo (95616) or InCor (95522)?

No. CMS 95616 is the English string “University of Sao Paulo.” CMS 95522 is InCor. This page is the FMUSP Hospital das Clínicas string only. We will not invent InCor studies here.

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

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

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

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

Is “University of Sao Paulo General Hospital” this campus?

No. Different NCT string (DEVICE n=7, rank 24), unmerged as on 95616. Landscape size is not an operator claim; bioaccess® does not operate this hospital.

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. Siblings: University of Sao Paulo, InCor HCFMUSP. Country: clinical trials in Brazil.

Julio G. Martinez-Clark, CEO · bioaccess®