Category: Advantages of Conducting Trials 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 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 Do not publish n=112 as if they were unique studies.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®

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 CONIS, 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 Clinica 20/20 as a bioaccess® client.

If you searched Clinica 20/20 first-in-human, Clinica 20 20 San José clinical trial, Clinica 20/20 CRO Costa Rica, or “go direct Clinica 20/20,” you followed a campus string ClinicalTrials.gov still publishes. Clinica 20/20 in San José, Costa Rica, is a real private clinic that appears on ClinicalTrials.gov as the facility string Clinica 20/20. It is not a first-in-human medical-device CRO, and it is not the operator of the CONIS file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns CONIS / MoH, accredited CEC, 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 San José Clinica 20/20 intercept. It does not clone Clinica Canela. Canela is a different building, a different NCT family, and a different query. Linking is correct. Cloning that page is not. bioaccess® does not operate this clinic.

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:

• Clinica 20/20 (San José, Costa Rica): DEVICE n=8 (rank 17). Sponsor class on that row: INDUSTRY:8. Example NCT IDs: NCT04058314, NCT04059796, NCT04574102.

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 “Clinica 20/20 clinical trial” or “Costa Rica device FIH clinic” finds an industry-heavy DEVICE campus string without finding CONIS, the 3% statutory canon, import, insurance, or 21 CFR 812.28. Eight industry DEVICE rows are registry volume, not a CRO product, and not a claim that bioaccess® ran any of them.

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:

• CONIS. CONIS and the Ministry of Health sit on Ley N.° 9234. Accredited CEC review, then CONIS registration. A hallway conversation in San José 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 Clinica 20/20 (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	CONIS / MoH 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 San José clinic string	Colombia (INVIMA) and the rest of the bioaccess® platform

How CONIS / MoH actually works (the short version)

Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews the protocol first; then the study is registered with CONIS / the Ministry of Health. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. Confirm the current calendar with qualified advisers; an NCT location row is not CONIS registration.

A statutory 3% CONIS canon on the study budget is published as a legal charge — not a CRO fee, and not a clinic markup we invent here. bioaccess® does not claim to operate this clinic and does not invent a Costa Rican legal entity on this page.

Use clinical-trials-costa-rica. 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 clinic email is not CONIS clearance. bioaccess® manages the file. That is CRO work, not site work.

Do not smear the hospital

Clinica 20/20 is a real San José clinic with industry DEVICE rows on a public ranking. That volume is not a punchline. This page is not a critique of those studies. It is also not a claim that the clinic is your FIH operator, that bioaccess® runs the clinic, or that we have a Costa Rican legal entity invented for this intercept. Use the site if the protocol fits. Hire the operator. Keep Clinica Canela on its own page.

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 CONIS / 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 Clinica 20/20 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 CONIS 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 Clinica Canela?

No. Canela is a separate Dominican / regional intercept already live. This page is Clinica 20/20 in San José, Costa Rica, under CONIS / Ley N.° 9234 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 CONIS / 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 3% CONIS charge a CRO fee?

No. It is a statutory canon on the study budget, as published on the Costa Rica country page. It is not a bioaccess® markup and not a clinic fee we invent here.

Does ranking INDUSTRY:8 mean bioaccess® was the sponsor?

No. INDUSTRY:8 is the ClinicalTrials.gov sponsor-class split on that DEVICE row. We will not invent those sponsors as clients. We will not invent a PI.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from named public press (XCath / Operation Robo Angel items retrieved 1 September 2026) and the published bioaccess® Panama country page. Press mention_n is not a bioaccess® claim that we ran this procedure. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the facilities, operators, and sponsor those sources support. We do not invent Clínica Norte as the implant hospital. We do not invent a CRO the wires did not name. We do not claim Clínica Norte, XCath, or this procedure as a bioaccess® client program.

If you searched Clínica Norte Santiago Panama first-in-human, Clínica Norte CRO, XCath Iris Panama, or “go direct Clínica Norte,” you followed a clinic name that is genuinely in the public file. Clínica Norte in Santiago, Panama, is a real building. In the XCath wires it is the remote operator site. It is not the implant hospital. It is not a first-in-human medical-device CRO. It is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the buildings are sites. The First-in-Human CRO still owns MINSA/CNBI, 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 Panama is not the only fit. Sponsors who skip the CRO and email either clinic still have to rebuild that stack. A press release that names a remote console does not become a CRO.

This page is the intercept for the Clínica Norte / remote-console query. The patient-side hospital intercept is already live: The Panama Clinic first-in-human (CMS 95513). Link it. Do not clone it. Do not move the implant to Santiago because the operator sat in Santiago.

What the press actually printed — two buildings, one patient

Device press writes the robot, the city, and the surgeons. It rarely writes the CRO. On the 1 September 2026 LATAM device FIH/EFS press sweep, Clínica Norte, Santiago, Panama, is rank 7, mention_n=4 — always paired with The Panama Clinic. Example URLs the ranking actually used:

• XCath / Business Wire, 19 March 2026 — world’s first remote robotic intervention in a stroke patient (Iris; Operation Robo Angel). The ranking log and matching trade read the same split: patient at The Panama Clinic; remote operator at Clínica Norte, Santiago.
• NeuroNews, 25 March 2026 — Vitor Pereira led the procedure from Clinica Norte in Santiago, Panama — more than 200 km from the patient in Panama City. Bedside: Anastasio Ameijeiras Sibauste (The Panama Clinic). The patient was transferred to The Panama Clinic and treated there. We will not rewrite that to put the implant in Santiago.
• Matching MassDevice and Fierce Biotech rewrites name both buildings. None of them name a CRO.

That is how a founder googles “Clínica Norte first-in-human” and concludes Santiago was the implant hospital. The wires do not say that. The patient was at The Panama Clinic. Clínica Norte held the remote console. We will not invent a CRO. We will not claim bioaccess® ran Operation Robo Angel. Named bioaccess® work at The Panama Clinic (Axoft, Newrotex) stays on the hospital intercept — not this XCath page.

Clínica Norte is a remote site. The Panama Clinic is the bedside hospital. The CRO is the operator.

A Santiago, Panama clinic can host a remote console. A Panama City hospital can host the patient, the angiography suite, and the bedside team. That is necessary. Neither building, by appearing in an XCath wire, becomes MINSA/CNBI, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager.

What either site can typically do when a sponsor “goes direct”:

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

What neither site is built to own for an investigational device:

• MINSA and CNBI. The national device file is not a hallway conversation with a remote operator or a bedside neurosurgeon.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. The Panama essay publishes a typical premium range of $5,000–$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for this protocol.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including how a remote console and a bedside hospital are documented as one investigation.
• The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-clinic MSA will not stretch.

Going direct to Clínica Norte is how you confirm a console room. Going direct to The Panama Clinic is how you confirm a bedside room. Neither is how you open a first-in-human device investigation.

Site versus CRO

Workstream	What the press actually assigned	What the CRO still owns
Remote console	Clínica Norte, Santiago, Panama — Vitor Mendes Pereira (University of Toronto) in the NeuroNews rewrite	Protocol fit, training, device accountability across both rooms
Patient / implant hospital	The Panama Clinic, Panama City — bedside Anastasio Ameijeiras Sibauste	Do not move this row to Santiago
Ethics	Institutional committee calendars at the host buildings	Packet, ICF, IB, CNBI-registered process covering both sites if both are on the file
National authority	Not the permit holder by appearing in an XCath wire	MINSA / CNBI
Import	Receiving and storage if contracted	Importer of record
Quality	Each building’s local quality and the case they physically ran	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 Panama buildings on one public story	Colombia (INVIMA) and the rest of the bioaccess® platform

How MINSA and CNBI actually work (the short version)

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

• Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority on device investigations. Ethics runs through institutional bioethics committees registered with CNBI.
• On clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks. Per-patient costs on that page: $12,000–$22,000. Currency is the U.S. dollar.
• On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); CNBI often 4–8 weeks; conservative submission-to-first-patient envelope 3–5 months including site prep and screening.
• Under 21 CFR 812.28, foreign clinical data from Panama is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ethics documentation. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Ask for a protocol-specific calendar. A clinic email from Santiago is not a MINSA approval. bioaccess® manages the submission. That is CRO work, not site work.

All bioaccess® Panama 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 either building — and do not invent Norte as the implant hospital

Clínica Norte and The Panama Clinic are serious clinical resources. Use the console site when the protocol needs a remote operator room. Use The Panama Clinic when the protocol needs that bedside hospital. Hire the operator for the file.

Do not assign the XCath patient to Clínica Norte. The NeuroNews rewrite places the patient at The Panama Clinic. Do not clone The Panama Clinic first-in-human. Do not add Nanochon on this page. Nanochon is HOLD as a client claim; its press names The Panama Clinic, not Norte.

What the CRO still does after you have a Norte slide

1. Regulatory-fit, not tourism. Panama is fast and bilingual. A remote-console clinic in Santiago is not automatically the right room for every device indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet — written so a remote console and a bedside hospital are one investigation if both are on the file.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate Clínica Norte, The Panama Clinic, or both only if they fit the protocol. Do not activate Norte as the implant hospital if the protocol’s patient is elsewhere.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a press-named console site.

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

Was the XCath patient treated at Clínica Norte?

Not according to the public wires this page cites. NeuroNews places the patient at The Panama Clinic, Panama City, with the remote operator at Clínica Norte, Santiago. We will not invent Norte as the implant hospital.

Can I contract Clínica Norte directly for a device FIH?

You can try. The clinic can discuss a console room, investigator interest, and local costs. It cannot, by appearing in four XCath URLs, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the right building for the right role.

Did bioaccess® run Operation Robo Angel / XCath?

No public bioaccess® case-study page names this program. We will not invent that claim. mention_n=4 is a press-URL count, not bioaccess® enrollment. Named bioaccess® FIH at The Panama Clinic remains Axoft and Newrotex on the live hospital intercept.

Next step

If the search that brought you here was Clínica Norte or XCath Panama, start as the operator: contact bioaccess® or book from First-in-Human CRO. Bedside hospital intercept: The Panama Clinic first-in-human. Country: clinical trials in Panama.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from named public press (Trendlines / Seger and PharmaDeviceNews, retrieved 1 September 2026) and the published bioaccess® El Salvador country page. Press mention_n is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current DNM/SRS, CNEIS, and FDA rules with qualified advisers. We name only the facility, PI, and sponsor those sources support. We do not invent a CRO the wires did not name. We do not claim Zacamil National Hospital or Seger Surgical Solutions as a bioaccess® client.

If you searched Zacamil National Hospital first-in-human, Zacamil Hospital CRO, SEGER IDEA El Salvador, or “go direct Zacamil San Salvador,” you followed a hospital name that is genuinely in the public file. Zacamil National Hospital / Zacamil Hospital in San Salvador is a real public hospital. It is not a first-in-human medical-device CRO, and it is not the operator of the DNM/SRS file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns DNM/SRS, CNEIS 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 San Salvador is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A press release that names the building does not become a CRO.

This page is the intercept for the Zacamil press cluster. It is distinct from Clínica Quesada / Quesada Clinic (already intercepted: Clínica Quesada San Salvador FIH — Horizon Polaris robotic cataract). Different building. Different device class. Linking is correct. Cloning Quesada is not. Hospital El Salvador, named on the country hub as landscape infrastructure, is also not this hospital and not a facility we operate.

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

Device press writes the implant, the city, the hospital, and sometimes the surgeon. It rarely writes the CRO. On the 1 September 2026 LATAM device FIH/EFS press sweep, Zacamil National Hospital / Zacamil Hospital, San Salvador, El Salvador, is rank 8, mention_n=3. Example URLs the ranking actually used:

• The Trendlines Group, 17 March 2026 — Seger Surgical Solutions announced successful completion of three first-in-human cases of the SEGER IDEA™ laparoscopic bowel closure device. Procedures conducted at Zacamil National Hospital in El Salvador. Quote in that item: Dr. Francisco Alabi, Zacamil National Hospital, El Salvador. No CRO named.
• Matching OTC / Trendlines syndication of the same company milestone (same building, same n=3).
• PharmaDeviceNews, 16 March 2026 — names Zacamil Hospital; three first-in-human procedures; bowel-closure times under two minutes as reported in that article. That rewrite does not always name the PI. We will not invent a PI on that URL. We name Alabi only where Trendlines already printed it.

That is useful public information about a press-named San Salvador FIH site. It is how a founder googles “SEGER El Salvador” or “Zacamil first-in-human” and lands on a public hospital without landing on SRS, CNEIS, importer of record, ISO 14155, or 21 CFR 812.28. We cite those URLs as facility evidence. We will not invent a CRO. We will not claim bioaccess® ran the Seger FIH. No live bioaccess® case-study page names this hospital as a client site.

A later ClinicalTrials.gov row (NCT07508592) exists for a Seger feasibility study listing Hospital Nacional Zacamil. This intercept is the press page. We will not pad mention_n with NCT counts. If you came from the registry, read the NCT as a location string, not as a CRO product.

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

A San Salvador national hospital can provide rooms, surgical staff, and an investigator the sponsor already put in the wire. 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 surgical service.
• Share local research rules and how the case would physically run.
• 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:

• DNM / SRS. Superintendencia de Regulación Sanitaria (SRS) replaced Dirección Nacional de Medicamentos (DNM) in August 2024. The published El Salvador hub puts study startup at 30–60 days via parallel SRS and CNEIS review on one digital platform. A hallway conversation at Zacamil is not that file.
• CNEIS. Comité Nacional de Ética de la Investigación en Salud. Centralized ethics. Spanish protocol package.
• Investigational import. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Zacamil-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
• Multi-country optionality. If San Salvador enrollment or the indication later needs Colombia, Panama, or another bioaccess® market, a single-hospital MSA will not stretch.

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

Site versus CRO

Workstream	What Zacamil (site) typically owns	What the CRO still owns
Procedure	Rooms, surgical service, local staff, source documents	Protocol fit, training, device accountability
Ethics	Local cooperation with the national ethics process	CNEIS packet, ICF, IB alignment
National authority	Not the permit holder by appearing in a Trendlines item	DNM/SRS (30–60 day startup already published on the country hub)
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital 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 San Salvador campus	Colombia (INVIMA) and the rest of the bioaccess® platform

How DNM/SRS and CNEIS actually work (the short version)

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

• SRS is the national regulatory authority (successor to DNM, August 2024). llms.txt still lists DNM; the live hub names both.
• Ethics is centralized at CNEIS. Parallel SRS + CNEIS on one digital platform is why the hub already publishes 30–60 day study startup.
• ~60% cost savings vs equivalent US programs, 98.5% GCP compliance across the published site network, and a US-dollar economy — already on that hub. We will not invent a Zacamil-only rate.
• This site does not publish DNM or SRS as PAHO/WHO Level 4. We will not invent that badge.
• Under 21 CFR 812.28, foreign clinical data from El Salvador is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper SRS authorization and CNEIS 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 email is not an SRS approval. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® El Salvador 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 — and do not merge Zacamil with Quesada

Zacamil National Hospital is a serious public resource. Three independent press URLs naming the building is a signal of public visibility, not a punchline. Use the site when the protocol fits. Hire the operator.

Do not merge this hospital into Clínica Quesada. Do not treat Hospital El Salvador (country-hub landscape name) as Zacamil. Different buildings. Different queries.

What the CRO still does after you have a Zacamil slide

1. Regulatory-fit, not tourism. El Salvador is a lead first-in-human jurisdiction on the published hub. One San Salvador 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 SRS / CNEIS 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 Zacamil only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a press-named hospital.

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 Zacamil National Hospital directly for a device FIH?

You can try. The hospital can discuss investigator interest and local procedure costs. It cannot, by appearing in three Seger URLs, become your SRS 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 SEGER IDEA first-in-human cases?

No public bioaccess® case-study page names this hospital. We will not invent that claim. mention_n=3 is a press-URL count, not bioaccess® enrollment.

Is this the same site as Clínica Quesada?

No. Quesada is a different San Salvador building already intercepted for a different public device story. This page is Zacamil only.

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

Regulatory-fit (El Salvador vs Colombia vs a multi-country design); the SRS/CNEIS packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one San Salvador room is not enough.

Next step

If the search that brought you here was Zacamil National Hospital or SEGER IDEA El Salvador, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in El Salvador. Distinct San Salvador clinic: Clínica Quesada.

Julio G. Martinez-Clark, CEO · bioaccess®