Category: Preparing for First-In-Human Studies

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

If you searched Hospital Clinico Universidad de Chile first-in-human, UChile clinical hospital Santiago clinical trial, Hospital Clínico Universidad de Chile CRO, or “go direct Hospital Clínico Universidad de Chile,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Clínico Universidad de Chile in Santiago is the public Universidad de Chile (UChile) clinical hospital string on ClinicalTrials.gov. It is not Hospital Clínico Universidad Católica. It is not Universidad Andrés Bello. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the public Universidad de Chile clinical hospital. Distinct from Hospital Clínico Universidad Católica (CMS 95626) and from Universidad Andrés Bello (CMS 95657). Católica is a different campus and a different query. UNAB is a different NCT university string. We do not clone press-named TMVR claims from the Católica page onto this hospital. We will not invent a PI.

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

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

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Hospital Clínico Universidad de Chile (Santiago, Chile) — canonical NCT string: ALL interventional n=32; DEVICE n=4. Batch-5 pick #7. Example NCT IDs: NCT01268423, NCT01739751, NCT02576574.
• Unaccented alias (same campus, same city): ALL n=27; DEVICE n=3. That alias is named here so a founder searching the unaccented spelling still lands on this slug. We do not publish a second slug. We do not add 32+27 or 4+3 as a unique-study union.

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 Clínico Universidad de Chile clinical trial” or “UChile FIH Santiago” finds a public campus string without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Clínico Universidad Católica or UNAB. A public clinical hospital is still not a CRO. We will not paste Católica press claims onto this page.

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:

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

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

How ISP actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Clínico Universidad de Chile is a serious public clinical hospital. ALL n=32 (DEVICE n=4) on the picks file is registry volume, not a punchline. The unaccented ALL=27 / DEVICE=3 row is a spelling alias, not a second hospital and not a union we invent. Do not merge it into Católica (CMS 95626) or UNAB (CMS 95657). Do not clone press-named TMVR claims from CMS 95626. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Clínico Universidad de Chile 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 ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Clínico Universidad Católica or Universidad Andrés Bello?

No. Católica is CMS 95626. UNAB is CMS 95657. This page is the public Universidad de Chile (UChile) clinical hospital only. We do not clone press-named TMVR claims from the Católica intercept.

Why two ALL n values on one page?

ClinicalTrials.gov stored an accented canonical string (ALL n=32; DEVICE n=4) and an unaccented alias (ALL n=27; DEVICE n=3). This page intercepts both as one campus. It does not add the counts.

Is n=32 plus n=27 equal to 59 unique studies?

We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a union. Same rule for DEVICE 4+3.

Is this the Catholic university hospital?

No. That is Hospital Clínico Universidad Católica (CMS 95626). This page is Universidad de Chile — a public university clinical hospital. Different rectorate. Different NCT strings.

Does ISP have PAHO/WHO Level 4 standing?

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

Next step

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

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 Centro de Investigación Clínica de Oaxaca as a bioaccess® client.

If you searched Centro de Investigacion Clinica de Oaxaca first-in-human, Oaxaca City clinical trial, CICO Oaxaca CRO, or “go direct Centro de Investigación Clínica de Oaxaca,” you followed a campus string ClinicalTrials.gov still publishes. Centro de Investigación Clínica de Oaxaca in Oaxaca City, Mexico, is a real named research-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the Oaxaca named research clinic. Distinct from INCMNSZ Salvador Zubirán (CMS 95623), INCan (CMS 95655), Hospital Civil de Guadalajara Fray Antonio Alcalde (CMS 95646), UNAM Optometry Clinic (CMS 95658), and Hospital Universitario Dr. José Eleuterio González (CMS 95643). Oaxaca City is not Mexico City, not Guadalajara, not Monterrey, and not a UNAM optometry lab.

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

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

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Centro de Investigacion Clinica de Oaxaca (Oaxaca City, Mexico): ALL interventional n=33; DEVICE n=0 on the picks file. Batch-5 pick #6. Example NCT IDs: NCT03498716, NCT03899155, NCT04365868.

Cite ALL n=33 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI.

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

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

That is the leak: a founder searching “Oaxaca clinical trial clinic” or “Centro de Investigación Clínica de Oaxaca FIH” finds ALL n=33 without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Guadalajara, UNAM optometry, or Eleuterio González. A named Oaxaca clinic is still not a CRO.

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

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

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

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

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

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

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

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.

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

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

Do not smear the clinic

Centro de Investigación Clínica de Oaxaca is a serious named clinic on the public registry. ALL n=33 is registry volume, not a punchline. Do not merge it into INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González. 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 Centro de Investigación Clínica de Oaxaca directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as INCMNSZ, INCan, Hospital Civil Guadalajara, UNAM optometry, or Eleuterio González?

No. INCMNSZ is CMS 95623 (Mexico City). INCan is CMS 95655 (Mexico City). Hospital Civil Guadalajara is CMS 95646. UNAM optometry is CMS 95658. Eleuterio González is CMS 95643 (Monterrey). This page is Centro de Investigación Clínica de Oaxaca, Oaxaca City only.

Is Oaxaca under a different national agency than Mexico City?

No. COFEPRIS is still the national file. Ethics typically 4–6 weeks; COFEPRIS 4–8 weeks after ethics; 2.8-month median combined start-up on the Mexico hub. Registro sanitario (~30 working days) is a different file.

Does ALL n=33 mean this clinic already owns COFEPRIS?

No. An NCT location row is not a COFEPRIS authorization. Keep trial clocks separate from registro.

Why DEVICE n=0?

That is the picks-file DEVICE count. We will not invent a DEVICE n from the CSV top-40 dump.

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.

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 INECO Neurociencias Oroño as a bioaccess® client.

If you searched INECO Neurociencias Orono first-in-human, INECO Rosario clinical trial, Neurociencias Oroño CRO, or “go direct INECO Neurociencias Oroño,” you followed a campus string ClinicalTrials.gov still publishes. INECO Neurociencias Oroño in Rosario, Argentina, is a real neuroscience-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the Rosario neuroscience-institute intercept. Distinct from Hospital Provincial del Centenario (CMS 95649) and from CIPREC (CMS 95641). Rosario is not Buenos Aires. A neuroscience institute is not a provincial hospital. Linking is correct. Collapsing Santa Fe province into Buenos Aires, or collapsing every Rosario string into Centenario, 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:

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• INECO Neurociencias Oroño (Rosario, Argentina): ALL interventional n=35; DEVICE n=0 on the picks file. Batch-5 pick #5. Example NCT IDs: NCT04634409, NCT04965675, NCT05164172.

Cite ALL n=35 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not invent a PI on this institute.

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

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

That is the leak: a founder searching “INECO Rosario clinical trial” or “Neurociencias Oroño FIH” finds ALL n=35 without finding ANMAT, import, insurance, or 21 CFR 812.28 — and without landing on Centenario Rosario or CIPREC. A Rosario neuroscience institute is still not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. 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.

How ANMAT actually works (the short version)

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

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

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

Do not smear the institute

INECO Neurociencias Oroño is a serious Rosario neuroscience resource. ALL n=35 is registry volume, not a punchline. Do not merge it into Centenario Rosario or CIPREC. Do not invent a PI. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract INECO Neurociencias Oroño directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Provincial del Centenario Rosario, CIPREC, or Sanatorio Parque Rosario?

No. Centenario is CMS 95649. CIPREC is CMS 95641 (Buenos Aires). Sanatorio Parque Rosario is a separate intercept in this batch and is not this institute. This page is INECO Neurociencias Oroño, Rosario only.

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 ALL n=35 mean this institute 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.

Is this the same campus as Sanatorio Parque?

No. Sanatorio Parque is a different Rosario NCT string (this batch, pick #8). Sharing a city is not a license to merge them.

Next step

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

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 CEPIC as a bioaccess® client.

If you searched CEPIC Sao Paulo first-in-human, Centro Paulista de Investigação Clínica clinical trial, CEPIC CRO Brazil, or “go direct CEPIC,” you followed a campus string ClinicalTrials.gov still publishes. CEPIC — Centro Paulista de Investigação Clínica — in São Paulo, Brazil, is a real named investigative-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named São Paulo investigative clinic. The clinic is the site. It is not the CRO. Distinct from CIPREC Buenos Aires (CMS 95641 — a different country, a different regulator, a different acronym), Hospital Israelita Albert Einstein, Hospital do Coração (HCor), and Hospital Santa Marcelina. Sharing São Paulo or sharing “investigative clinic” in the name is not a license to collapse them.

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

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

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• CEPIC – Centro Paulista de Investigação Clínica (São Paulo, Brazil): ALL interventional n=35; DEVICE n=0 on the picks file. Batch-5 pick #4. Example NCT IDs: NCT01885078, NCT02689362, NCT03987919.

Cite ALL n=35 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not treat the word “Investigação Clínica” as proof this campus is your FIH operator.

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

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

That is the leak: a founder searching “CEPIC São Paulo clinical trial” or “Centro Paulista de Investigação Clínica FIH” finds ALL n=35 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CIPREC, Einstein, HCor, or Santa Marcelina. A named investigative clinic is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the clinic

CEPIC is a serious named São Paulo investigative clinic on the public registry. ALL n=35 is registry volume, not a punchline, and not a claim that the clinic is a device CRO. Do not merge it into CIPREC, Einstein, HCor, or Santa Marcelina. 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 CEPIC directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as CIPREC, Einstein, HCor, or Santa Marcelina?

No. CIPREC is CMS 95641 in Buenos Aires (ANMAT). Einstein, HCor, and Santa Marcelina are separate São Paulo hospital intercepts. This page is CEPIC — Centro Paulista de Investigação Clínica — only. The named clinic is the site, not the CRO.

Is CEPIC the same as CIPREC?

No. CIPREC is Buenos Aires (CMS 95641). CEPIC is São Paulo. Different letters, different country, different regulator.

Does “Investigação Clínica” in the name mean this clinic owns ANVISA?

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A clinic name is not a dossier.

Did bioaccess® run NCT03987919 because it also appears on another campus in this batch?

No. An NCT ID can list more than one facility. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

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

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 CEDOES Vitória as a bioaccess® client.

If you searched CEDOES Vitoria first-in-human, CEDOES Vitória clinical trial, Centro de Diagnóstico e Pesquisa da Osteoporose do ES CRO, or “go direct CEDOES Vitória,” you followed a campus string ClinicalTrials.gov still publishes. CEDOES in Vitória, Espírito Santo, Brazil, is a real named research-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Vitória / Espírito Santo intercept. There is no prior Vitória CMS slug. Aliases named on the picks file — Centro de Diagnóstico e Pesquisa da Osteoporose do ES — merge onto this slug. We do not invent an expansion beyond what the picks file states. We do not invent extra n for aliases. We do not clone São Paulo, Porto Alegre, or Rio Preto campuses onto Espírito Santo.

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

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

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• CEDOES (Vitória, Brazil): ALL interventional n=37; DEVICE n=0 on the picks file. Batch-5 pick #3. Example NCT IDs: NCT01147289, NCT03987919, NCT04184622.

Alias on this slug only: Centro de Diagnóstico e Pesquisa da Osteoporose do ES. The picks file does not give a second n for that expansion. We will not invent one. We will not invent a unique-study union.

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

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

That is the leak: a founder searching “CEDOES Vitória clinical trial” or “osteoporosis ES research clinic FIH” finds ALL n=37 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28. Espírito Santo is still not a CRO product, and not a claim that bioaccess® ran any of those IDs.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the clinic

CEDOES is a serious Espírito Santo research clinic on the public registry. ALL n=37 is registry volume, not a punchline. Do not invent a second slug for the osteoporosis-center expansion. Do not invent extra n. 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 CEDOES Vitória directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as a prior Vitória CMS page, or a São Paulo / Porto Alegre clone?

No. There is no prior Vitória CMS slug. This page does not clone Einstein, HCPA, Santa Casa Porto Alegre, FAMERP, or any São Paulo hospital intercept. It is CEDOES, Vitória, Espírito Santo only.

Is Centro de Diagnóstico e Pesquisa da Osteoporose do ES a different campus?

No. The picks file lists that expansion as an alias of CEDOES. One slug. We do not invent a second n.

Does ALL n=37 mean this clinic is a device CRO?

No. n is unique NCT IDs per facility string. Combined ethics + ANVISA still typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A named clinic is the site, not the operator.

Why DEVICE n=0?

That is the picks-file DEVICE count. We will not invent a DEVICE ranking from the CSV top-40 dump.

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.

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 Santa Casa de Belo Horizonte as a bioaccess® client.

If you searched Santa Casa Belo Horizonte first-in-human, Santa Casa de Misericordia de Belo Horizonte clinical trial, Santa Casa BH CRO, or “go direct Santa Casa de Belo Horizonte,” you followed a campus string ClinicalTrials.gov still publishes. Santa Casa de Misericórdia de Belo Horizonte in Belo Horizonte, Minas Gerais, Brazil, is a real hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Belo Horizonte Santa Casa intercept. Distinct from Irmandade da Santa Casa de Misericórdia de Porto Alegre (CMS 95651). That is a different city, a different state (Rio Grande do Sul vs Minas Gerais), and a different NCT string family. Sharing the words “Santa Casa” is not a license to collapse them. This page is not a Porto Alegre 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:

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Santa Casa de Misericordia de Belo Horizonte (Belo Horizonte, Brazil): ALL interventional n=38; DEVICE n=0 on the picks file. Batch-5 pick #2. Example NCT IDs: NCT00071331, NCT00412893, NCT00413218.

Cite ALL n=38 as given. We will not invent a DEVICE ranking from the top-40 CSV. We will not borrow a Porto Alegre Santa Casa 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 hospital name lands on a campus without landing on an operator.

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

That is the leak: a founder searching “Santa Casa Belo Horizonte clinical trial” finds ALL n=38 without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Santa Casa Porto Alegre. Minas Gerais is not Rio Grande do Sul. An NCT city field is not a license to collapse every Santa Casa.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation in Belo Horizonte is not a Porto Alegre 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-hospital MSA will not stretch.

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Santa Casa de Belo Horizonte is a serious Minas Gerais resource. ALL n=38 is registry volume, not a punchline. Do not merge it into Santa Casa Porto Alegre (CMS 95651). Do not smear that campus by treating every Santa Casa string as one ANVISA file. 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 Belo Horizonte directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Santa Casa de Porto Alegre?

No. Irmandade da Santa Casa de Misericórdia de Porto Alegre is CMS 95651. Different city. Minas Gerais vs Rio Grande do Sul. This page is Santa Casa de Misericórdia de Belo Horizonte only.

Is Belo Horizonte the same metro as Porto Alegre?

No. Porto Alegre is Rio Grande do Sul. Belo Horizonte is Minas Gerais. Sharing a hospital-order name does not make them one CEP or one ANVISA file.

Does ALL n=38 mean this campus already owns ANVISA?

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub.

Why DEVICE n=0?

That is the picks-file DEVICE count for this string. We will not invent a DEVICE n from the CSV top-40 dump.

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. Porto Alegre Santa Casa sibling (do not merge): Santa Casa Porto Alegre.

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 Liga Norte Riograndense Contra o Câncer as a bioaccess® client.

If you searched Liga Norte Riograndense Contra o Cancer first-in-human, Liga Norte Riograndense Natal clinical trial, Liga contra o câncer Natal CRO, or “go direct Liga Norte Riograndense Contra o Câncer,” you followed a campus string ClinicalTrials.gov still publishes. Liga Norte Riograndense Contra o Câncer in Natal, Rio Grande do Norte, Brazil, is a real cancer-league hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the Natal cancer-league intercept. Distinct from Barretos Cancer Hospital (CMS 95648), ICESP (CMS 95642), INEN Lima (CMS 95644), INCan Mexico (CMS 95655), Hospital Erasto Gaertner (CMS 95656), and Hospital Amaral Carvalho (CMS 95652). Natal is not Barretos, not São Paulo, not Lima, not Mexico City, not Curitiba, and not Jaú. An oncology NCT string is not a license to collapse every cancer campus in Latin America.

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

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

Counts come from /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md (ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file n values. We do not invent a global CSV rank. Press mention_n = 0 on every row in that table.

• Liga Norte Riograndense Contra O Cancer (Natal, Brazil) — canonical NCT string: ALL interventional n=39; DEVICE n=1. Batch-5 pick #1. Example NCT IDs: NCT01909453, NCT02312258, NCT03268954.
• Accented duplicate string (same campus, same city): ALL n=24. That alias is named here so a founder searching the ç/â spelling still lands on this slug. We do not publish a second slug. We do not add 39+24 as a unique-study union.

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 “Liga Norte Riograndense clinical trial” or “Natal cancer hospital FIH” finds a public campus string without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho. Registry volume in Natal 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:

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

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

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Liga Norte Riograndense Contra o Câncer is a serious Natal resource. ALL n=39 (DEVICE n=1) on the picks file is registry volume, not a punchline. The accented ALL=24 row is a spelling alias, not a second hospital and not a union we invent. Do not merge it into Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho. 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 Liga Norte Riograndense Contra o Câncer directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Barretos, ICESP, INEN, INCan, Erasto Gaertner, or Amaral Carvalho?

No. Barretos is CMS 95648. ICESP is CMS 95642. INEN is CMS 95644 (Lima, Peru — INS, not ANVISA). INCan is CMS 95655 (Mexico City, COFEPRIS). Erasto Gaertner is CMS 95656. Amaral Carvalho is CMS 95652 (Jaú). This page is the Natal Liga Norte Riograndense campus only.

Why two ALL n values on one page?

ClinicalTrials.gov stored an unaccented canonical string (ALL n=39; DEVICE n=1) and an accented duplicate (ALL n=24). This page intercepts both as one campus. It does not add the counts.

Is n=39 plus n=24 equal to 63 unique studies?

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

Does DEVICE n=1 mean this campus already owns ANVISA for a new device FIH?

No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 1 is a registry token, not a dossier.

Next step

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

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 UNAM Optometry Clinic as a bioaccess® client.

If you searched UNAM Optometry Clinic first-in-human, Optometry Clinic National Autonomous University Mexico City clinical trial, UNAM optometry CRO, or “go direct UNAM Optometry Clinic,” you followed a campus string ClinicalTrials.gov still publishes. The ranking string is Optometry Clinic, National Autonomous University, Mexico City, Mexico. It is a university optometry clinic. It is the site, not the CRO. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the UNAM optometry-clinic intercept. Distinct from INCMNSZ Salvador Zubirán (CMS 95623), Instituto Nacional de Cancerología (this batch), and CODET Vision Institute Tijuana. A university clinic in Mexico City is not a Tijuana ophthalmic hospital and not a national institute. We will not invent a PI.

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:

• Optometry Clinic, National Autonomous University (Mexico City, Mexico): DEVICE n=10 (rank 12). INDUSTRY:10. Example NCT IDs: NCT02299869, NCT02727816, NCT02847169.

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 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 clinic as a client site.

That is the leak: a founder searching “UNAM optometry clinical trial” or “Optometry Clinic National Autonomous University FIH” finds a DEVICE campus (n=10, rank 12, INDUSTRY:10) without finding COFEPRIS, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, or CODET. A university optometry clinic with an all-industry DEVICE split is still a site. It is not a CRO.

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

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

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

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

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

• 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 at a UNAM optometry clinic is not that file, and it is not an INCan or 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-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 UNAM Optometry Clinic (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 UNAM optometry DEVICE string (no ALL row) — not INCMNSZ, INCan, 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 clinic

The UNAM optometry clinic is a real Mexico City university clinic. DEVICE n=10 (rank 12, INDUSTRY:10) is registry volume, not a punchline. Do not invent an ALL n. Do not invent a PI. Do not merge it into INCMNSZ, INCan, or CODET Tijuana. The clinic is the site, not the CRO. 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 UNAM Optometry Clinic directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your 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 clinic. 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, INCan, or CODET Tijuana?

No. INCMNSZ is CMS 95623. Instituto Nacional de Cancerología is a separate intercept in this batch. CODET is the Tijuana ophthalmic intercept. This page is the NCT string Optometry Clinic, National Autonomous University, Mexico City, Mexico 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 clinic 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?

The dump did not publish an ALL row for this string. We cite DEVICE n=10 (rank 12, INDUSTRY:10) only. We will not invent an ALL count.

Is a university optometry clinic a CRO?

No. The clinic is the site. DEVICE n=10 does not make UNAM the COFEPRIS applicant or importer of record. We will not invent a PI.

Are the COFEPRIS clocks different from INCan on this batch?

No. Same Mexico hub: ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; combined start-up 2.8-month median; registro sanitario ~30 working days separate.

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 ISP, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Universidad Andrés Bello as a bioaccess® client.

If you searched Universidad Andres Bello first-in-human, UNAB Santiago clinical trial, Universidad Andrés Bello CRO Chile, or “go direct Universidad Andrés Bello,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Andrés Bello in Santiago, Chile, is a real university string on ClinicalTrials.gov. It is an NCT university campus, not Hospital Clínico Universidad Católica. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the NCT university string only. Distinct from Hospital Clínico Universidad Católica (CMS 95626; slug hospital-clinico-universidad-catolica-santiago-fih). Different campus. Different query. We do not clone press-named TMVR claims onto this page. We will not invent a PI.

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:

• Universidad Andrés Bello (Santiago, Chile): DEVICE n=7 (rank 23). OTHER:7. Example NCT IDs: NCT02884427, NCT03636386, NCT04008602.

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 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 university campus as a client site.

That is the leak: a founder searching “Universidad Andrés Bello clinical trial” or “UNAB Santiago FIH” finds a DEVICE campus (n=7, rank 23, OTHER:7) without finding ISP, Law 20.120, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Clínico Universidad Católica. A university DEVICE string is not a CRO.

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

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

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

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

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

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on a UNAB campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP.
• 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 Universidad Andrés Bello (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	ISP 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 UNAB Santiago DEVICE string (no ALL row in the dump) — not Hospital Clínico Universidad Católica	Colombia (INVIMA) and the rest of the bioaccess® platform

How ISP actually works (the short version)

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

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 campus email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site work.

Do not smear the university

Universidad Andrés Bello is a serious Santiago academic resource. DEVICE n=7 (rank 23, OTHER:7) is registry volume, not a punchline. Do not invent an ALL n. Do not merge it into Hospital Clínico Universidad Católica. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Universidad Andrés Bello directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university campus. 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 Clínico Universidad Católica (CMS 95626)?

No. CMS 95626 is Hospital Clínico Universidad Católica (hospital-clinico-universidad-catolica-santiago-fih). This page is Universidad Andrés Bello, an NCT university string only. Different campus. We do not clone that intercept’s press facts.

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

Regulatory-fit (this country versus Colombia versus a multi-site design); the ISP / 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 university campus 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?

The dump did not publish an ALL interventional row for this string. We cite DEVICE n=7 (rank 23, OTHER:7) only. We will not invent an ALL count.

Is this the same campus as Hospital Clínico Universidad Católica?

No. That is CMS 95626. Universidad Andrés Bello is a different NCT string. Sharing Santiago does not merge ISP files.

Is the 30-business-day ISP figure commercial registration?

No. Typical ISP review ~30 business days is the study/import side on Chile blogs. Commercial ISP registration 30–90 days is a different file. Law 20.120 still governs the Ethical-Scientific Committee. We will not invent PAHO/WHO Level 4 for ISP.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Chile. Distinct campus: Hospital Clínico Universidad Católica.

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 Erasto Gaertner as a bioaccess® client.

If you searched Hospital Erasto Gaertner first-in-human, Erasto Gaertner Curitiba clinical trial, Erasto Gaertner CRO, or “go direct Hospital Erasto Gaertner,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Erasto Gaertner in Curitiba, Brazil, is a real hospital string on ClinicalTrials.gov. Curitiba is not Porto Alegre and not São Paulo. 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 Curitiba Erasto Gaertner intercept. Distinct from Porto Alegre campuses (HCPA, Moinhos, PUCRS, Conceição, Dornelles, Santa Casa) and from São Paulo-state cancer campuses (ICESP, Barretos). Paraná is not Rio Grande do Sul and not the capital of São Paulo.

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 Erasto Gaertner (Curitiba, Brazil), DEVICE list: n=5 (rank 38). INDUSTRY:2; OTHER:2; NETWORK:1. Example NCT IDs: NCT00385983, NCT03368313, NCT03721978.
• Same facility on the ALL interventional list: n=55 (rank 18). INDUSTRY:42; OTHER:11; NETWORK:2. Example NCT IDs: NCT00083304, NCT00382031, NCT00385983.

Cite DEVICE and ALL as given. NCT00385983 appears on both example sets because the dump printed it on both rows. That overlap does not merge Curitiba into Porto Alegre or ICESP.

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 “Erasto Gaertner clinical trial” finds both a DEVICE campus (n=5, rank 38) and an ALL campus (n=55, rank 18) without finding ANVISA, import, insurance, or 21 CFR 812.28 — and without landing on ICESP, Barretos, or any Porto Alegre hospital. Curitiba registry volume is still not a CRO. NETWORK tokens are not named networks we invent as clients.

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 in Curitiba is not that dossier, and it is not an ICESP, Barretos, or Porto Alegre 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 Erasto Gaertner (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 Curitiba hospital NCT string (DEVICE and ALL listed separately) — not Porto Alegre campuses, ICESP, or Barretos	Colombia (INVIMA) and the rest of the bioaccess® platform

How ANVISA actually works (the short version)

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

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

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

Do not smear the hospital

Hospital Erasto Gaertner is a serious Curitiba resource. DEVICE n=5 (rank 38) and ALL n=55 (rank 18) are registry volume, not a punchline. Do not merge it into Porto Alegre campuses or into ICESP or Barretos. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital Erasto Gaertner 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, ICESP, or Barretos Cancer Hospital?

No. HCPA is CMS 95615 (Porto Alegre). ICESP is CMS 95642 (São Paulo). Barretos is CMS 95648. This page is Hospital Erasto Gaertner, Curitiba only. DEVICE and ALL are two filters on one facility string, not two hospitals.

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 cite both DEVICE n=5 and ALL n=55?

The 1 September 2026 dump published both rows for this facility string. DEVICE rank 38 (n=5; INDUSTRY:2; OTHER:2; NETWORK:1) and ALL rank 18 (n=55; INDUSTRY:42; OTHER:11; NETWORK:2). We cite both. We do not pretend DEVICE n is ALL n.

Does NCT00385983 on both lists merge this campus with ICESP?

No. Shared example IDs across filters are facility evidence. They do not move Curitiba to São Paulo. We still will not invent a PI.

Is Curitiba a Porto Alegre alias?

No. Porto Alegre campuses stay on their own intercepts. This page is Paraná.

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. Cancer-campus siblings: ICESP, Barretos.

Julio G. Martinez-Clark, CEO · bioaccess®