Category: First-in-Human

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

If you searched Santa Casa Porto Alegre first-in-human, Irmandade da Santa Casa de Misericórdia de Porto Alegre clinical trial, Santa Casa CRO Brazil, or “go direct Santa Casa de Misericórdia de Porto Alegre,” you followed a campus string ClinicalTrials.gov still publishes. Irmandade da Santa Casa de Misericórdia de Porto Alegre is a real hospital string family on ClinicalTrials.gov. Two spellings of one campus appear in the dump. This page merges those aliases. It does not invent a unique-study union. 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 two NCT spellings of one Porto Alegre campus. It does not clone HCPA (CMS 95615), Moinhos de Vento (CMS 95622), São Lucas PUCRS (CMS 95636), Conceição (CMS 95640), or Hospital Ernesto Dornelles (this batch). We do not merge UFRGS into Santa Casa or into HCPA.

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:

• Irmandade da Santa Casa de Misericórdia de Porto Alegre (Porto Alegre, Brazil): ALL interventional n=42 (rank 34). Example NCT IDs: NCT00774930, NCT01125566, NCT01149044.
• Irmandade Santa Casa de Misericordia de Porto Alegre (Porto Alegre, Brazil): ALL interventional n=41 (rank 36). Example NCT IDs: NCT00040183, NCT00448812, NCT00658359.

Those are two facility-string rows. We list each n. We do not add them as a unique-study union. We will not invent a DEVICE n or a combined n of 83.

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 campus 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 Casa Porto Alegre clinical trial” finds two near-duplicate campus strings (n=42 rank 34, and n=41 rank 36) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, Moinhos, PUCRS, Conceição, or Dornelles. Two spellings are still one operator problem. Adding the n values would pretend they are two independent study sets. They are not cited that way here.

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 local 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 Casa is not that dossier, and it is not an HCPA, Moinhos, or Dornelles 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-site 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 Casa de Misericórdia de Porto Alegre (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 Santa Casa campus, two NCT spellings listed separately — not HCPA, Moinhos, PUCRS, Conceição, or Dornelles	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Santa Casa de Misericórdia de Porto Alegre is a serious hospital. Two ALL rows (n=42 rank 34; n=41 rank 36) are registry spelling volume, not a punchline and not a union we invent. Do not merge it into HCPA, Moinhos, PUCRS, Conceição, or Dornelles. Do not merge UFRGS 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 Santa Casa de Misericórdia de Porto Alegre 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, Moinhos, PUCRS, Conceição, Dornelles, or UFRGS?

No. HCPA is CMS 95615. Moinhos is CMS 95622. São Lucas PUCRS is CMS 95636. Conceição is CMS 95640. Ernesto Dornelles is a separate intercept in this batch. UFRGS is skipped rather than cloned onto HCPA. This page is the Santa Casa Porto Alegre alias merge 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 two n values on one page?

ClinicalTrials.gov stored two spellings (ALL n=42 rank 34, and ALL n=41 rank 36). This page intercepts both as one campus. It does not add the counts.

Is n=42 plus n=41 equal to 83 unique studies?

We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a union.

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, Moinhos de Vento, São Lucas PUCRS. 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 Ernesto Dornelles as a bioaccess® client.

If you searched Hospital Ernesto Dornelles first-in-human, Ernesto Dornelles Porto Alegre clinical trial, Dornelles CRO Brazil, or “go direct Hospital Ernesto Dornelles,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Ernesto Dornelles in Porto Alegre, Brazil, is a real hospital string on ClinicalTrials.gov. It is not HCPA, not Moinhos, not São Lucas, and not Santa Casa. 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 Ernesto Dornelles campus intercept. Distinct from Hospital de Clínicas de Porto Alegre (CMS 95615), Fundação Universitaria de Cardiologia (CMS 95612), Hospital Moinhos de Vento (CMS 95622), Hospital São Lucas da PUCRS (CMS 95636), Hospital Nossa Senhora da Conceição (CMS 95640), and Santa Casa de Misericórdia de Porto Alegre (this batch). Multiple Porto Alegre buildings. Multiple queries. We do not merge UFRGS into this page or into HCPA.

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 Ernesto Dornelles (Porto Alegre, Brazil): ALL interventional n=42 (rank 32). INDUSTRY:36; OTHER:6. Example NCT IDs: NCT01724034, NCT01994967, NCT02118584.

Cite ALL only as given. We will not invent a DEVICE n. We will not borrow an HCPA count onto this campus.

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 campus 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 “Ernesto Dornelles clinical trial” finds rank 32 on ALL (n=42, INDUSTRY:36; OTHER:6) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on HCPA, FUC, Moinhos, PUCRS, Conceição, or Santa Casa. Porto Alegre has several hospitals. An NCT city field is not a license to collapse 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 local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at Ernesto Dornelles is not that dossier, and it is not an HCPA, Moinhos, or Santa Casa 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-site 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 Ernesto Dornelles (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 Ernesto Dornelles Porto Alegre NCT string — not HCPA, FUC, Moinhos, PUCRS, Conceição, or Santa Casa	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Ernesto Dornelles is a serious Porto Alegre resource. n=42 ALL (rank 32) is registry volume, not a punchline. Do not merge it into HCPA, FUC, Moinhos, PUCRS, Conceição, or Santa Casa. Do not merge UFRGS 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 Ernesto Dornelles 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, Moinhos, PUCRS, Conceição, Santa Casa, or UFRGS?

No. HCPA is CMS 95615. FUC is CMS 95612. Moinhos is CMS 95622. São Lucas PUCRS is CMS 95636. Conceição is CMS 95640. Santa Casa is a merged-alias intercept in this batch. UFRGS is not an intercept on this page and is not merged into HCPA. This page is Hospital Ernesto Dornelles only.

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

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

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

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

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

No. HCPA is CMS 95615. Ernesto Dornelles is a different NCT string. Sharing Porto Alegre does not make them one ANVISA file.

Does INDUSTRY:36 mean this campus is already a device FIH operator?

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

Why not merge UFRGS here?

UFRGS is a different facility family. Merging it would clone HCPA. We skip that merge rather than invent a third campus from that dump row.

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, Moinhos de Vento, São Lucas PUCRS. 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 ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Provincial del Centenario as a bioaccess® client.

If you searched Hospital Provincial del Centenario first-in-human, Hospital Provincial del Centenario Rosario clinical trial, Centenario Rosario CRO, or “go direct Hospital Provincial del Centenario,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Provincial del Centenario in Rosario, Argentina, is a real provincial hospital string on ClinicalTrials.gov. Rosario is not Buenos Aires, not Pilar, not Córdoba, and not La Plata. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the Rosario Centenario intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), CIPREC (CMS 95641), Hospital Universitario Austral (CMS 95638), Sanatorio Allende (CMS 95645), Hospital Italiano de La Plata (CMS 95647), Hospital Británico de Buenos Aires (this batch), Sagrada Familia / ENERI (CMS 95625), and Hospital Italiano Asunción (CMS 95517). Linking is correct. Collapsing Santa Fe province into Buenos Aires because both are Argentina 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 Provincial del Centenario (Rosario, Argentina): ALL interventional n=43 (rank 30). INDUSTRY:42; OTHER:1. Example NCT IDs: NCT01321255, NCT01663727, NCT02100696.

Cite ALL only as given. We will not invent a DEVICE n for this string.

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 campus 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 “Centenario Rosario clinical trial” or “Hospital Provincial del Centenario FIH” finds rank 30 on ALL (n=43, INDUSTRY:42; OTHER:1) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, CIPREC, Austral, Allende, La Plata, or Británico. Rosario is a different city. Registry volume there is still not a CRO, and INDUSTRY:42 is a sponsor-class token, not a client list 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 local research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in Rosario is not that file. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
• 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-site 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 Provincial del Centenario (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Rosario provincial-hospital NCT string — not HIBA, CIPREC, Austral, Allende, La Plata, Británico, ENERI, or Asunción	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Provincial del Centenario is a serious Rosario resource. n=43 ALL (rank 30) is registry volume, not a punchline. Do not merge it into HIBA, CIPREC, Austral, Allende, La Plata, Británico, ENERI, or Asunción. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Provincial del Centenario directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as HIBA, CIPREC, Austral, Allende, La Plata, Británico, ENERI, or Asunción Italiano?

No. HIBA is CMS 95620. CIPREC is CMS 95641. Austral is CMS 95638. Allende is CMS 95645. La Plata is CMS 95647. ENERI is CMS 95625. Asunción is CMS 95517 (DINAVISA, Paraguay). Hospital Británico de Buenos Aires is a separate intercept in this batch. This page is Hospital Provincial del Centenario, Rosario only.

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

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

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

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

Is Rosario under a different national agency than Buenos Aires?

No. ANMAT is still the national file. The 90-business-day statutory trial-auth target pauses for RFIs. Trial versus registro remain separate.

Does INDUSTRY:42 mean bioaccess® ran those studies?

No. That is the ALL-row sponsor-class split. 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 Argentina. Buenos Aires sibling: Hospital Italiano de Buenos Aires.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Barretos Cancer Hospital first-in-human, Hospital de Amor Barretos clinical trial, Barretos CRO Brazil, or “go direct Barretos Cancer Hospital,” you followed a campus string ClinicalTrials.gov still publishes. Barretos Cancer Hospital in Barretos, Brazil, is a real hospital string on ClinicalTrials.gov. Barretos is not São Paulo capital and not São José do Rio Preto. 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 Barretos intercept. Distinct from ICESP (this batch), FAMERP (this batch), University of Sao Paulo (CMS 95616), and Hospital das Clínicas FMUSP (CMS 95630). Unused in batch 2 on purpose; this batch ships it. Do not swap in Hospital Británico. CMS slug barretos-cancer-hospital-fih is the intercept.

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:

• Barretos Cancer Hospital (Barretos, Brazil): DEVICE n=7 (rank 21). Sponsor class on that row: OTHER:6; NETWORK:1. Example NCT IDs: NCT01410175, NCT02142244, NCT02500966.

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 “Barretos Cancer Hospital clinical trial” finds a DEVICE campus (n=7, rank 21, OTHER:6; NETWORK:1) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, FAMERP, USP, or HCFMUSP. Interior São Paulo state is still not a CRO product. NETWORK:1 is a registry sponsor-class token, not a named network we will invent as a client.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Barretos is not that dossier, and it is not an ICESP or FAMERP 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 Barretos Cancer 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 Barretos DEVICE string (no ALL row in the dump) — not ICESP, FAMERP, USP, or HCFMUSP	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Barretos Cancer Hospital is a serious interior São Paulo resource. DEVICE n=7 (rank 21) is registry volume, not a punchline. Do not invent an ALL n. Do not merge Barretos into ICESP, FAMERP, USP, or HCFMUSP. 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 Barretos Cancer Hospital 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 ICESP, FAMERP, USP, or HCFMUSP?

No. USP is CMS 95616. HCFMUSP is CMS 95630. ICESP and FAMERP are separate intercepts in this batch. This page is Barretos Cancer Hospital only. We will not invent an ALL n that the dump did not publish.

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 is there no ALL n?

Because the 1 September 2026 dump did not publish an ALL interventional row for this facility string. We cite DEVICE n=7 (rank 21) only. We will not invent an ALL count.

Does OTHER:6; NETWORK:1 mean bioaccess® ran these studies?

No. That is the ClinicalTrials.gov sponsor-class split on the DEVICE row. We will not invent those parties as clients. We will not invent a PI.

Is Barretos the same as ICESP?

No. ICESP is São Paulo (ALL n=54, rank 19). Barretos is a different city and a DEVICE-only row. Unused in batch 2 on purpose; this batch ships it. Do not swap Hospital Británico onto this slug.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Italiano de La Plata first-in-human, Italiano La Plata clinical trial, HILP CRO Argentina, or “go direct Hospital Italiano de La Plata,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Italiano de La Plata in La Plata, Argentina, is a real hospital. La Plata is not Buenos Aires Recoleta and not Asunción. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the La Plata Italiano intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620) and from Hospital Italiano Asunción (CMS 95517). Three Italiano names. Three countries or cities. Three regulators on the Asunción side versus ANMAT here and in Buenos Aires. Do not collapse. Distinct also from CIPREC, Austral, ENERI, and Sanatorio Allende.

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 Italiano de La Plata (La Plata, Argentina): ALL interventional n=42 (rank 33). Example NCT IDs: NCT00094302, NCT00504075, NCT00545532.

Cite ALL only as given. We will not invent a DEVICE n. Sharing an example NCT ID with CIPREC does not merge the campuses.

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 Italiano de La Plata clinical trial” finds rank 33 on ALL (n=42) and may collapse it into HIBA or into Asunción. Those are different buildings. n=42 is registry volume, not a clone of CMS 95620 or CMS 95517, and not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in La Plata is not that file, and it is not a HIBA file. Asunción is DINAVISA — a different country.
• 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 Italiano de La Plata (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One La Plata Italiano NCT string — not HIBA, not Asunción, not CIPREC	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Italiano de La Plata is a serious La Plata resource. n=42 ALL is registry volume, not a punchline. Do not smear HIBA by cloning it here. Do not smear Asunción by collapsing three Italiano names. Three names, three cities or countries. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Italiano de La Plata directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

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

No. HIBA is CMS 95620 (Buenos Aires, ANMAT). Asunción Italiano is CMS 95517 (Paraguay, DINAVISA). This page is Hospital Italiano de La Plata only. CIPREC, Austral, ENERI, and Sanatorio Allende remain separate strings.

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

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

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

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

Why three Italiano pages?

Because ClinicalTrials.gov stores three facility families: Buenos Aires, La Plata, and Asunción (Sanatorio Italiano / Italian Hospital). Sponsors search all three. Linking is correct. Cloning CMS 95620 or CMS 95517 onto this slug is not.

Is La Plata a neighborhood of Buenos Aires for ANMAT purposes?

No. It is a different city and a different NCT string. ANMAT is still the national agency; the hospital is not HIBA. Trial authorization versus registro remain separate petitions. 90 business days is a statutory target that pauses for RFIs, not a campus email.

Does sharing NCT00094302 with CIPREC make them one site?

No. Example IDs are dump evidence. Multi-site NCT rows can list more than one facility. That does not merge CIPREC into Hospital Italiano de La Plata, and it does 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. Buenos Aires sibling: Hospital Italiano de Buenos Aires. Asunción sibling: Hospital Italiano Asunción FIH. Country: clinical trials in Argentina.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Civil de Guadalajara first-in-human, Fray Antonio Alcalde clinical trial, Hospital Civil Guadalajara CRO, or “go direct Hospital Civil de Guadalajara Fray Antonio Alcalde,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Civil de Guadalajara Fray Antonio Alcalde in Guadalajara, Mexico, is a real civil-hospital string on ClinicalTrials.gov. Guadalajara is not Mexico City and not Monterrey. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Guadalajara Civil intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623, Mexico City), Hospital Universitario Dr. José Eleuterio González in Monterrey (this batch), and CODET Vision Institute Tijuana. Same COFEPRIS clocks as the Monterrey intercept. Different building. Different city.

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

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

• Hospital Civil de Guadalajara Fray Antonio Alcalde (Guadalajara, Mexico): ALL interventional n=42 (rank 31). Example NCT IDs: NCT00413218, NCT00737724, NCT01262677.

Cite ALL only as given. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “Hospital Civil Guadalajara clinical trial” or “Fray Antonio Alcalde FIH” finds rank 31 on ALL (n=42) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, Eleuterio Monterrey, or CODET. Three Mexican cities. Three queries.

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

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

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

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

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

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

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

Site versus CRO

Workstream	What Hospital Civil de Guadalajara Fray Antonio Alcalde (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	COFEPRIS 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 Guadalajara civil-hospital NCT string — not INCMNSZ, Eleuterio Monterrey, or CODET	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS actually works (the short version)

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

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 COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

Do not smear the hospital

Hospital Civil de Guadalajara Fray Antonio Alcalde is a serious Guadalajara resource. n=42 ALL is registry volume, not a punchline. Do not merge it into INCMNSZ, Eleuterio González, or CODET. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Civil de Guadalajara Fray Antonio Alcalde directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. 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 INCMNSZ, Eleuterio González Monterrey, or CODET Tijuana?

No. INCMNSZ is CMS 95623. CODET is the Tijuana ophthalmic intercept. Hospital Universitario Dr. José Eleuterio González is the Monterrey intercept in this batch. This page is Hospital Civil de Guadalajara Fray Antonio Alcalde 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 COFEPRIS / 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.

Same COFEPRIS clocks as Monterrey — same hospital?

No. Same national agency, different city. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub; registro sanitario ~30 working days separate. Clocks copy from the INCMNSZ country-hub language. They do not merge campuses.

Is this CODET?

No. CODET is Tijuana and ophthalmic. This page is a Guadalajara civil hospital ALL string. Do not copy CODET claims here.

Does n=42 ALL replace importer-of-record work?

No. Ranking is unique NCT IDs. Investigational import is still ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. INCMNSZ sibling: INCMNSZ Salvador Zubirán.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Sanatorio Allende first-in-human, Sanatorio Allende Córdoba clinical trial, Allende CRO Argentina, or “go direct Sanatorio Allende,” you followed a campus string ClinicalTrials.gov still publishes. Sanatorio Allende in Córdoba, Argentina, is a real private hospital string on ClinicalTrials.gov. Córdoba is not Buenos Aires and not Pilar. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the Córdoba Allende intercept. Distinct from Hospital Italiano de Buenos Aires (CMS 95620), Hospital Universitario Austral (CMS 95638, Pilar), Hospital Italiano de La Plata (this batch), CIPREC (this batch), Sagrada Familia / ENERI (CMS 95625), and Hospital Italiano Asunción (CMS 95517). Interior Argentina is not a Buenos Aires clone.

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:

• Sanatorio Allende (Córdoba, Argentina): ALL interventional n=51 (rank 24). Example NCT IDs: NCT00428948, NCT00578786, NCT00699972.

Cite ALL only as given. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “Sanatorio Allende clinical trial” or “Córdoba FIH hospital” finds rank 24 on ALL (n=51) without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Austral, CIPREC, or La Plata. Córdoba is a different city. Registry volume there is still not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation in Córdoba is not that file. Trial authorization and commercial registro remain separate petitions — same Argentina hub used on the HIBA intercept.
• 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 Sanatorio Allende (site) typically owns	What the CRO still owns
Procedure	Rooms, caseload, local staff, source documents	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not the permit holder by appearing on an NCT	ANMAT clinical-investigation file
Import	Receiving and storage if contracted	Importer of record
Quality	Hospital or university quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Córdoba hospital NCT string — not HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANMAT actually works (the short version)

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

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

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

Do not smear the hospital

Sanatorio Allende is a serious Córdoba resource. n=51 ALL is registry volume, not a punchline. Do not merge it into HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Sanatorio Allende directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as HIBA, Austral, CIPREC, La Plata, ENERI, or Asunción Italiano?

No. HIBA is CMS 95620 (Buenos Aires). Austral is CMS 95638 (Pilar). ENERI is CMS 95625. Asunción is CMS 95517. CIPREC and Hospital Italiano de La Plata are separate intercepts in this batch. This page is Sanatorio Allende, Córdoba only.

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

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

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

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

Is Córdoba under a different national agency than Buenos Aires?

No. ANMAT is still the national file. The city is different; the trial-versus-registro split is not. Statutory trial-auth target remains on the order of 90 business days and pauses for RFIs. A Córdoba NCT row is not ANMAT clearance.

Does rank 24 ALL mean this hospital is already the FIH operator?

No. n is unique NCT IDs on one facility string. It is not ISO 14155 monitoring, not importer of record, and not 21 CFR 812.28. No public bioaccess® case-study page names this hospital.

Can I treat Allende, HIBA, and Austral as one Argentina MSA?

No. Three NCT strings. Three cities or campuses. A single-hospital MSA will not stretch. The CRO still owns multi-site optionality, including Colombia.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched INEN Lima first-in-human, Instituto Nacional de Enfermedades Neoplasicas clinical trial, INEN CRO Peru, or “go direct INEN Lima,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Enfermedades Neoplasicas (INEN) in Lima, Peru, is a real national cancer-institute string on ClinicalTrials.gov. The ranking dump stores it without an accent: Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. bioaccess® does not operate INEN. It is not a first-in-human medical-device CRO, and it is not the operator of the INS file.

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

This page is the Lima INEN intercept. It is not a Brazil, Mexico, or Argentina campus. It does not clone ICESP or Barretos. Sharing an oncology search query is not a license to merge countries. We do not invent a Peruvian legal entity on this page.

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

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

• Instituto Nacional de Enfermedades Neoplasicas (Lima, Peru): ALL interventional n=51 (rank 23). Example NCT IDs: NCT00002850, NCT00005970, NCT00022516.

Cite ALL only as given. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “INEN Lima clinical trial” finds rank 23 on ALL (n=51) without finding INS, DIGEMID, import, insurance, or 21 CFR 812.28. A national cancer-institute ranking is registry volume, not a CRO, and not a Peruvian entity 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:

• INS. INS (DIIS, formerly OGITT) authorizes trials in Peru. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. A hallway conversation in Lima is not that stack. We will not invent DIGESA onto this page.
• 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 INEN (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	INS / DIGEMID 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 Lima national cancer-institute NCT string	Colombia (INVIMA) and the rest of the bioaccess® platform

How INS / DIGEMID actually works (the short version)

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

bioaccess® does not claim to operate INEN and does not invent a Peruvian legal entity on this page. The hospital remains the site. The CRO still owns the file.

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 INS authorization or a DIGEMID import permit. bioaccess® manages the file. That is CRO work, not site work.

Do not smear the hospital

INEN is a serious Lima national institute. n=51 ALL is registry volume, not a punchline. This page is not a claim that bioaccess® operates INEN or that we have a Peruvian legal entity invented for the intercept. Use the site if the protocol fits. Hire the operator. Keep ICESP and Barretos on their Brazil pages.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract INEN Lima directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

No. Those are Brazilian NCT strings under ANVISA. This page is Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru, under INS / DIGEMID 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 INS / 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 DIGEMID the only agency?

No. Name both. INS (DIIS, formerly OGITT) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. Do not collapse the stack into “just DIGEMID.” We will not invent DIGESA.

Is the 40-business-day figure a device-FIH guarantee?

No. It is a published statutory target on the Peru hub in the drug-trial framework; 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. We will not invent a new clock. Ask for a protocol-specific calendar.

Does bioaccess® operate INEN or have a Peruvian entity named here?

No. We do not claim to operate INEN and do not invent a Peruvian legal entity. The hospital is the site. The ~30% lower versus US/EU figure is already on the Peru hub — not an INEN quote.

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 Peru.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Universitario Eleuterio Gonzalez first-in-human, HU UANL Monterrey clinical trial, Jose Eleuterio Gonzalez CRO, or “go direct Hospital Universitario Dr. José Eleuterio González,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Universitario Dr. José Eleuterio González in Monterrey, Mexico, is a real university hospital. ClinicalTrials.gov stores the facility with quotes: Hospital Universitario “Dr. Jose Eleuterio Gonzalez”, Monterrey, Mexico. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Monterrey Eleuterio González intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623, Mexico City) and from CODET Vision Institute Tijuana. Different city. Different NCT string. Do not clone either. Distinct also from Hospital Civil de Guadalajara Fray Antonio Alcalde in this batch.

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 “Dr. Jose Eleuterio Gonzalez” (Monterrey, Mexico): ALL interventional n=52 (rank 21). Example NCT IDs: NCT00543439, NCT01500551, NCT01818752.

Cite ALL only as given. We will not invent a DEVICE n. Quotes in the NCT string are how the dump stored the campus; they are not a second hospital.

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 “Eleuterio González clinical trial” or “HU Monterrey FIH” finds rank 21 on ALL (n=52) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ or CODET. Monterrey is not Mexico City and not Tijuana.

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

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

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

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

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

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

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

Site versus CRO

Workstream	What Hospital Universitario Dr. José Eleuterio González (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	COFEPRIS 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 Monterrey university-hospital NCT string — not INCMNSZ, CODET, or Guadalajara Civil	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS actually works (the short version)

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

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 COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

Do not smear the hospital

Hospital Universitario Dr. José Eleuterio González is a serious Monterrey academic resource. n=52 ALL is registry volume, not a punchline. Do not merge it into INCMNSZ Mexico City or CODET Tijuana. Do not merge it into Hospital Civil de Guadalajara. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Universitario Dr. José Eleuterio González directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page intercepts the search; it does not claim the studies. 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 INCMNSZ, CODET Tijuana, or Hospital Civil de Guadalajara?

No. INCMNSZ is CMS 95623 (Mexico City). CODET is the Tijuana ophthalmic intercept. Hospital Civil de Guadalajara Fray Antonio Alcalde is a separate intercept in this batch. This page is the Monterrey quoted NCT string 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 COFEPRIS / 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.

Are the quotes in the NCT name a different campus?

No. The dump stores Hospital Universitario “Dr. Jose Eleuterio Gonzalez” as one Monterrey facility string. We intercept that spelling. We will not invent a second n from punctuation.

Is the 2.8-month median a guarantee for this hospital?

No. Combined start-up 2.8-month median is published on the live Mexico hub, not a campus-only clock we invent. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; registro sanitario ~30 working days is a separate petition. Ask for a protocol-specific calendar.

Does ranking in Monterrey replace Colombia?

No. bioaccess® still runs clinical trials in Colombia. A Mexican campus string is not a reason to drop INVIMA optionality. We pick the country the device needs.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. INCMNSZ sibling: INCMNSZ Salvador Zubirán.

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 ICESP as a bioaccess® client.

If you searched ICESP first-in-human, Instituto do Cancer do Estado de Sao Paulo clinical trial, ICESP CRO, or “go direct ICESP,” you followed a campus string ClinicalTrials.gov still publishes. Instituto do Cancer do Estado de Sao Paulo – ICESP in São Paulo is a real cancer-institute string on ClinicalTrials.gov. bioaccess® does not operate that institute. 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 Instituto do Cancer do Estado de Sao Paulo – ICESP only. Distinct from University of Sao Paulo (CMS 95616), Hospital das Clínicas FMUSP (CMS 95630), and InCor HCFMUSP (CMS 95522). The cancer institute string is not the general HC campus and not the university string. Do not copy heart-institute device claims here. Distinct also from FAMERP and Barretos in this batch.

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:

• Instituto do Cancer do Estado de Sao Paulo – ICESP (São Paulo, Brazil): ALL interventional n=54 (rank 19). Example NCT IDs: NCT00567190, NCT00950300, NCT01120184.

Cite ALL only as given. We will not invent a DEVICE n for this string.

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 “ICESP clinical trial” finds a cancer-institute campus (ALL n=54, rank 19) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on USP, HCFMUSP, or InCor. A cancer-institute ranking is registry volume, not a CRO, and not a merged HC campus.

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 ICESP is not that dossier, and it is not a USP, HCFMUSP, or 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 ICESP (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 ICESP cancer-institute NCT string — not USP, HCFMUSP, or InCor	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

ICESP is a serious São Paulo cancer institute. n=54 ALL is registry volume, not a punchline. Do not merge it into the university string, the general Hospital das Clínicas FMUSP campus, or InCor. Do not smear Barretos or FAMERP by collapsing every Brazilian cancer campus. 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 ICESP directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as USP (95616), HCFMUSP (95630), or InCor (95522)?

No. CMS 95616 is University of Sao Paulo. CMS 95630 is Hospital das Clínicas FMUSP. CMS 95522 is InCor. This page is Instituto do Cancer do Estado de Sao Paulo – ICESP only. We will not invent InCor or USP 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 ICESP the same as Hospital das Clínicas FMUSP?

No. The cancer-institute string is not the general HC campus. HCFMUSP is CMS 95630. Sharing a city is not a license to clone that intercept or to copy its DEVICE n here.

Is this Barretos Cancer Hospital?

No. Barretos is a different city and a different NCT string (DEVICE n=7, rank 21, no ALL row). This page is ICESP in São Paulo.

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

Julio G. Martinez-Clark, CEO · bioaccess®