Category: First-in-Human

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

If you searched Centenario Hospital Miguel Hidalgo first-in-human, Hospital Miguel Hidalgo Aguascalientes clinical trial, Miguel Hidalgo CRO Mexico, or “go direct Centenario Hospital Miguel Hidalgo,” you followed a campus string ClinicalTrials.gov still publishes. Centenario Hospital Miguel Hidalgo in Aguascalientes, Mexico, is a real named public-hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

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

This page is the named Aguascalientes public hospital. It is not Hospital Provincial del Centenario in Rosario (CMS 95649) and it is not Hospital Cardiologica Aguascalientes (CMS 95693). “Centenario” in Rosario is a different country and a different city. Sharing Aguascalientes is not a license to collapse this hospital into the cardiology clinic already live there.

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-10-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Centenario Hospital Miguel Hidalgo (Aguascalientes, Mexico) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT00269828, NCT00920816, NCT01120184.

Cite canonical ALL n=23 and DEVICE n=0. We will not invent an alias union with Rosario Centenario or with Hospital Cardiologica Aguascalientes. We will not invent a DEVICE n. We do not ship a second slug for 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 “Hospital Miguel Hidalgo Aguascalientes first-in-human” or “Centenario Hospital Miguel Hidalgo clinical trial” finds canonical ALL n=23 (DEVICE n=0) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes. A named public hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 on this campus is not that file. A hallway conversation at Miguel Hidalgo is not a Rosario Centenario file and is not a Hospital Cardiologica Aguascalientes 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 hospital

Centenario Hospital Miguel Hidalgo is a serious named Aguascalientes public hospital on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Hospital Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes. 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 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 Centenario Hospital Miguel Hidalgo directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Provincial del Centenario Rosario or Hospital Cardiologica Aguascalientes?

No. Hospital Provincial del Centenario is CMS 95649 in Rosario, Argentina — different country, different city. Hospital Cardiologica Aguascalientes is CMS 95693, a different NCT string in the same Mexican city. This page is Centenario Hospital Miguel Hidalgo only.

Is this Hospital Provincial del Centenario in Rosario?

No. Rosario Centenario is CMS 95649. Argentina versus Mexico is the filter. “Centenario” in the name is not a merge key.

Is this Hospital Cardiologica Aguascalientes?

No. That is CMS 95693. Same city is not the same hospital. This page is Centenario Hospital Miguel Hidalgo.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=23 is still not COFEPRIS authorization. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median start-up on the Mexico hub; registro ~30 working days.

Did bioaccess® run NCT00269828?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. Aguascalientes sibling (do not merge): Hospital Cardiologica Aguascalientes. 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 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 Instituto Nacional de Cardiología Ignacio Chávez as a bioaccess® client.

If you searched Instituto Nacional de Cardiologia Ignacio Chavez first-in-human, Ignacio Chávez clinical trial, INC Ignacio Chávez CRO Mexico, or “go direct Instituto Nacional de Cardiología Ignacio Chávez,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Nacional de Cardiologia Ignacio Chavez in Mexico City is a real named national cardiology-institute 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Mexico City national cardiology institute. It is not INCMNSZ (CMS 95623), not Instituto Nacional de Cancerología (INCan, CMS 95655), not Hospital Cardiologica Aguascalientes (CMS 95693), not InCor (CMS 95522), and not HCor (CMS 95633). Sharing a cardiology search is not a license to collapse them. Accented Instituto Nacional de Cardiología Ignacio Chávez and Tlalpan / México city-label strings are the same campus on this slug; we do not ship a second slug.

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-10-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto Nacional de Cardiologia Ignacio Chavez (Mexico City, Mexico) — canonical NCT string: ALL interventional n=23; DEVICE n=1. Example NCT IDs: NCT00517738, NCT00578786, NCT00777920.
• Accented alias Instituto Nacional de Cardiología Ignacio Chávez: ALL n=8. Listed separately. Same slug. We do not invent a unique-study union of 23+8. We do not ship a second slug for the accents.
• Tlalpan city-label string: ALL n=4. Listed separately. Same campus. Same slug. No union.
• México city-label strings are the same campus on this slug, not a second slug. We do not invent an extra unique-study count for those labels.

Cite canonical ALL n=23 and DEVICE n=1. Cite accented ALL n=8 and Tlalpan ALL n=4 separately. Do not add them.

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 “Ignacio Chávez first-in-human” or “Instituto Nacional de Cardiología Ignacio Chávez clinical trial” finds canonical ALL n=23 (DEVICE n=1) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on INCMNSZ, INCan, Hospital Cardiologica Aguascalientes, InCor, or HCor. A named national institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• 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 on this campus is not that file. A hallway conversation at Ignacio Chávez is not an INCMNSZ file, not an INCan file, not an Aguascalientes cardiology file, and not an InCor or HCor 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 institute

Instituto Nacional de Cardiologia Ignacio Chavez is a serious named Mexico City national cardiology institute on the public registry. ALL n=23 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into INCMNSZ, INCan, Hospital Cardiologica Aguascalientes, InCor, or HCor. 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 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 Instituto Nacional de Cardiología Ignacio Chávez 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 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 institute. 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 Cardiologica Aguascalientes, InCor, or HCor?

No. INCMNSZ is CMS 95623. INCan is CMS 95655. Hospital Cardiologica Aguascalientes is CMS 95693. InCor is CMS 95522. HCor is CMS 95633. This page is Instituto Nacional de Cardiologia Ignacio Chavez only. Accented ALL n=8 and Tlalpan ALL n=4 stay listed separately; we do not union.

Should I add canonical ALL n=23, accented ALL n=8, and Tlalpan ALL n=4?

No. Alias n is listed separately. A unique-study union is not published. Accents and Tlalpan / México city-label strings stay on this slug.

Is this INCMNSZ or INCan?

No. INCMNSZ is CMS 95623. INCan is CMS 95655. Those are other Mexico City national-institute intercepts. This page is the cardiology institute only.

Why DEVICE n=1?

That is the ranking-table DEVICE count for this string. It is still not COFEPRIS authorization. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median start-up on the Mexico hub; registro ~30 working days.

Did bioaccess® run NCT00517738?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. Mexico City sibling (do not merge): INCMNSZ. INCan sibling: Instituto Nacional de Cancerología.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Instituto de Investigaciones Clinicas Quilmes first-in-human, IIC Quilmes clinical trial, Quilmes CRO Argentina, or “go direct Instituto de Investigaciones Clínicas Quilmes,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Investigaciones Clinicas Quilmes in Quilmes, Argentina, is a real named clinical-research-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the named Quilmes institute. It is city-distinct from Instituto de Investigaciones Clínicas Mar del Plata (this batch, a different slug) and from leftover IIC Rosario / Córdoba strings (not this page). It is not Centro de Investigaciones Médicas Mar del Plata (CMS 95699), not CIPREC (CMS 95641), and not CINME (CMS 95669). Sharing an “investigaciones clínicas” token is not a license to collapse them. Alias Instituto de Investigaciones Clinicas Quilmes SRL stays on this slug; we do not ship a second slug.

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-10-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto de Investigaciones Clinicas Quilmes (Quilmes, Argentina) — canonical NCT string: ALL interventional n=23; DEVICE n=1. Example NCT IDs: NCT01885078, NCT01975376, NCT02760433.
• Legal-suffix alias Instituto de Investigaciones Clinicas Quilmes SRL: ALL n=5. Listed separately. Same slug. We do not invent a unique-study union of 23+5. We do not ship a second slug for the SRL suffix.

Cite canonical ALL n=23 and DEVICE n=1. Cite alias ALL n=5 separately. Do not add them. We will not invent extra DEVICE IDs.

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

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

That is the leak: a founder searching “IIC Quilmes first-in-human” or “Instituto de Investigaciones Clínicas Quilmes clinical trial” finds canonical ALL n=23 (DEVICE n=1) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on IIC Mar del Plata, leftover IIC Rosario or Córdoba, CIM MdP, CIPREC, or CINME. A named institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Quilmes is not a Mar del Plata IIC file, not a Rosario leftover file, and not a CIPREC or CINME file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANMAT actually works (the short version)

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

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

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

Do not smear the institute

Instituto de Investigaciones Clinicas Quilmes is a serious named Quilmes research institute on the public registry. ALL n=23 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into IIC Mar del Plata, leftover IIC Rosario or Córdoba, CIM MdP, CIPREC, or CINME. 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 Instituto de Investigaciones Clínicas Quilmes 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 IIC Mar del Plata, leftover IIC Rosario, CIM MdP, CIPREC, or CINME?

No. Instituto de Investigaciones Clínicas Mar del Plata is a different organization on its own slug in this batch. Leftover IIC Rosario / Córdoba strings are city-distinct and not this page. CIM MdP is CMS 95699. CIPREC is CMS 95641. CINME is CMS 95669. This page is Instituto de Investigaciones Clinicas Quilmes only. SRL alias ALL n=5 stays listed separately; we do not union.

Should I add canonical ALL n=23 and SRL alias ALL n=5?

No. Alias n is listed separately. A unique-study union is not published. The SRL suffix is the same Quilmes campus on the same slug.

Is this Instituto de Investigaciones Clínicas Mar del Plata?

No. That is a different organization in a different city, on its own slug in this batch. Sharing an IIC token is not a merge.

Why DEVICE n=1?

That is the ranking-table DEVICE count for this string. It is still not ANMAT authorization. A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. Trial versus registro remain different petitions.

Did bioaccess® run NCT01885078?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mar del Plata sibling in this batch (do not merge): Instituto de Investigaciones Clínicas Mar del Plata. Live CIM sibling (do not merge): Centro de Investigaciones Médicas Mar del Plata.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Instituto Alexander Fleming first-in-human, Alexander Fleming Buenos Aires clinical trial, IAF Buenos Aires CRO, or “go direct Instituto Alexander Fleming,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Alexander Fleming in Buenos Aires, Argentina, is a real named oncology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the named Buenos Aires oncology institute. It is not Hospital Italiano de Buenos Aires (CMS 95620), not Hospital Británico (CMS 95654), not ICESP (CMS 95642), not Barretos (CMS 95648), not A.C. Camargo (CMS 95691), not CORI (CMS 95672), not Liga Norte (CMS 95659), and not INCan (CMS 95655). Sharing Buenos Aires or sharing an oncology search 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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto Alexander Fleming (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=23; DEVICE n=1. Example NCT IDs: NCT00026338, NCT00040183, NCT00069745.

Cite canonical ALL n=23 and DEVICE n=1. We will not invent an alias union with HIBA or Británico. We will not invent extra DEVICE IDs. DEVICE n=1 is first-alpha among remaining ALL=23 DEVICE=1 rows in this pick table; that is a ranking note, not a quality claim.

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 “Instituto Alexander Fleming first-in-human” or “Alexander Fleming Buenos Aires clinical trial” finds canonical ALL n=23 (DEVICE n=1) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on HIBA, Británico, ICESP, Barretos, Camargo, CORI, Liga Norte, or INCan. A named oncology institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Fleming is not a HIBA file, not a Británico file, and not an ICESP, Barretos, Camargo, CORI, Liga Norte, or INCan file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANMAT actually works (the short version)

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

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

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

Do not smear the institute

Instituto Alexander Fleming is a serious named Buenos Aires oncology institute on the public registry. ALL n=23 and DEVICE n=1 are registry volume, not a punchline. Do not merge it into HIBA, Británico, ICESP, Barretos, Camargo, CORI, Liga Norte, or INCan. 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 Instituto Alexander Fleming 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 HIBA, Hospital Británico, ICESP, Barretos, A.C. Camargo, CORI, Liga Norte, or INCan?

No. HIBA is CMS 95620. Británico is CMS 95654. ICESP is CMS 95642. Barretos is CMS 95648. Camargo is CMS 95691. CORI is CMS 95672. Liga Norte is CMS 95659. INCan is CMS 95655. This page is Instituto Alexander Fleming, Buenos Aires only.

Is this Hospital Italiano de Buenos Aires?

No. HIBA is CMS 95620. This page is Instituto Alexander Fleming. Sharing Buenos Aires is not a merge.

Is this ICESP, Barretos, Camargo, or INCan?

No. Those are already-live oncology intercepts in Brazil or Mexico. This page is Buenos Aires, Argentina.

Why DEVICE n=1?

That is the ranking-table DEVICE count for this string. It is still not ANMAT authorization. A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. Trial versus registro remain different petitions.

Did bioaccess® run NCT00026338?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires sibling (do not merge): Hospital Italiano de Buenos Aires. São Paulo oncology sibling (do not merge): A.C. Camargo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Universidade Federal do Rio de Janeiro first-in-human, UFRJ clinical trial, Federal University of Rio de Janeiro CRO, or “go direct Universidade Federal do Rio de Janeiro,” you followed a campus string ClinicalTrials.gov still publishes. Universidade Federal do Rio de Janeiro (UFRJ) in Rio de Janeiro, Brazil, is a real named university 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the UFRJ university NCT string. It is not IBPClin (this batch, a named investigative institute on a different slug). It is not Instituto Nacional de Cancer Rio (different NCT string, leftover, not this page). It is not University of São Paulo (CMS 95616), not UNIFESP (CMS 95632), and not UFMG (CMS 95675). Sharing a Brazilian federal-university search 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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Universidade Federal do Rio de Janeiro (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=23; DEVICE n=2. Example NCT IDs: NCT00023452, NCT00151892, NCT00656721.

Cite canonical ALL n=23 and DEVICE n=2. We will not invent an alias union with IBPClin. We will not invent a DEVICE n beyond the ranking table. Instituto Nacional de Cancer Rio stays leftover, not this page.

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

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

That is the leak: a founder searching “UFRJ first-in-human” or “Universidade Federal do Rio de Janeiro clinical trial” finds canonical ALL n=23 (DEVICE n=2) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on IBPClin, Instituto Nacional de Cancer Rio, USP, UNIFESP, or UFMG. A named university string is still a site. An NCT location row is not a CRO.

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

A named university 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 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 university 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 UFRJ is not an IBPClin file, not an Instituto Nacional de Cancer Rio file, and not a USP, UNIFESP, or UFMG 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 university

Universidade Federal do Rio de Janeiro is a serious named university on the public registry. ALL n=23 and DEVICE n=2 are registry volume, not a punchline. Do not merge it into IBPClin, Instituto Nacional de Cancer Rio, USP, UNIFESP, or UFMG. 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 ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Universidade Federal do Rio de Janeiro directly for a device FIH?

You can try. The university 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 university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as IBPClin, Instituto Nacional de Cancer Rio, USP, UNIFESP, or UFMG?

No. IBPClin is the Rio clinic slug in this batch. Instituto Nacional de Cancer Rio is a different NCT string and leftover, not this page. USP is CMS 95616. UNIFESP is CMS 95632. UFMG is CMS 95675. This page is UFRJ only.

Is this IBPClin?

No. IBPClin is Instituto Brasil de Pesquisa Clínica, a named investigative institute on its own slug in this batch. UFRJ is the university string.

Is this Instituto Nacional de Cancer Rio?

No. That is a different NCT string and leftover, not this page. Sharing Rio de Janeiro is not a merge.

Is this USP, UNIFESP, or UFMG?

No. Those are already-live university intercepts in other Brazilian cities. This page is Universidade Federal do Rio de Janeiro.

Did bioaccess® run NCT00023452?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. São Paulo university sibling (do not merge): University of Sao Paulo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched University of Campinas first-in-human, UNICAMP clinical trial, Universidade Estadual de Campinas CRO, or “go direct University of Campinas,” you followed a campus string ClinicalTrials.gov still publishes. University of Campinas (UNICAMP) in Campinas, Brazil, is a real named university 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the UNICAMP university NCT string. It is not Centro de Pesquisa São Lucas Campinas (CMS 95689). Sharing Campinas is not a license to collapse them. Piracicaba Dental School is a school campus of the same university system, not this slug. Aliases Universidade Estadual de Campinas and short UNICAMP stay on this slug; we do not ship second slugs.

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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• University of Campinas (Campinas, Brazil) — canonical NCT string: ALL interventional n=23; DEVICE n=4. Example NCT IDs: NCT00787553, NCT01032798, NCT01125254.
• Alias Universidade Estadual de Campinas (Campinas): ALL n=14. Listed separately. Same slug. No union.
• Alias UNICAMP (Campinas): ALL n=2. Listed separately. Same slug. No union.

Cite canonical ALL n=23 and DEVICE n=4. Cite each alias n separately. Do not add 23+14+2. DEVICE n=4 is the highest DEVICE among remaining ALL=23 rows in this pick table; we will not invent extra DEVICE IDs. Piracicaba Dental School is not this slug.

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 university as a client site.

That is the leak: a founder searching “UNICAMP first-in-human” or “University of Campinas clinical trial” finds canonical ALL n=23 (DEVICE n=4) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Centro de Pesquisa São Lucas Campinas or on Piracicaba Dental School as a second hospital slug. A named university string is still a site. An NCT location row is not a CRO.

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

A named university 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 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 university 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 on the UNICAMP university string is not a São Lucas Campinas research-center file and is not a Piracicaba Dental School 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 university

University of Campinas is a serious named university on the public registry. ALL n=23 and DEVICE n=4 are registry volume, not a punchline. Do not merge it into Centro de Pesquisa São Lucas Campinas. Do not republish Piracicaba Dental School as this slug. 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 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 University of Campinas directly for a device FIH?

You can try. The university 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 university. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as Centro de Pesquisa São Lucas Campinas or Piracicaba Dental School?

No. São Lucas Campinas is CMS 95689, a named research-center string. Piracicaba Dental School is a school campus, not this slug. Universidade Estadual de Campinas ALL n=14 and UNICAMP ALL n=2 stay listed separately on this page; we do not union.

Should I add ALL n=23, Universidade Estadual n=14, and UNICAMP n=2?

No. Alias n is listed separately. A unique-study union is not published. Portuguese and short strings stay on this slug.

Is this Centro de Pesquisa São Lucas Campinas?

No. São Lucas Campinas is CMS 95689. This page is the University of Campinas / UNICAMP university string.

Is Piracicaba Dental School this page?

No. Piracicaba Dental School is a school campus, not this slug. We do not ship it as a second UNICAMP hospital intercept here.

Did bioaccess® run NCT00787553?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Brazil. Campinas sibling (do not merge): Centro de Pesquisa São Lucas Campinas.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Medical Care and Research Merida first-in-human, Medical Care and Research SA de CV clinical trial, Mérida CRO Mexico, or “go direct Medical Care and Research Mérida,” you followed a campus string ClinicalTrials.gov still publishes. Medical Care and Research SA de CV in Mérida, Yucatán, Mexico, is a real named research-clinic string on ClinicalTrials.gov. This is the first Mérida slug in this intercept series. 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 named Mérida clinic. It is not Oaxaca (CMS 95664), not FAICIC Veracruz (CMS 95670), not Scientia Chihuahua (CMS 95692), not Clinical Research Institute Tlalnepantla (CMS 95683), not INCMNSZ (CMS 95623), and not INCan (CMS 95655). Sharing a Mexican research-clinic search is not a license to collapse them. Punctuation alias Medical Care & Research SA de CV stays on this slug; we do not ship a second slug.

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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Medical Care and Research SA de CV (Mérida, Mexico) — canonical NCT string: ALL interventional n=24; DEVICE n=0. Example NCT IDs: NCT04255433, NCT04365868, NCT05256654.
• Punctuation alias Medical Care & Research SA de CV (Mérida): ALL n=23. Listed separately. Same slug. We do not invent a unique-study union of 24+23. We do not ship a second slug for the ampersand.

Cite canonical ALL n=24 and DEVICE n=0. Cite alias ALL n=23 separately. Do not add them. We will not invent a DEVICE n. First Mérida slug.

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 “Medical Care and Research Mérida clinical trial” or “Medical Care and Research SA de CV FIH” finds canonical ALL n=24 (DEVICE n=0) without finding COFEPRIS, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Oaxaca, FAICIC, Scientia, CRI Tlalnepantla, INCMNSZ, or INCan. A named 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:

• 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 on this campus is not that file. A hallway conversation in Mérida is not an Oaxaca, FAICIC, Scientia, Tlalnepantla, INCMNSZ, or INCan 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

Medical Care and Research SA de CV is a serious named Mérida research clinic on the public registry. ALL n=24 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Oaxaca, FAICIC, Scientia, CRI Tlalnepantla, INCMNSZ, or INCan. 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 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 Medical Care and Research Mérida 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 Oaxaca, FAICIC, Scientia Chihuahua, CRI Tlalnepantla, INCMNSZ, or INCan?

No. Oaxaca is CMS 95664. FAICIC is CMS 95670. Scientia is CMS 95692. CRI Tlalnepantla is CMS 95683. INCMNSZ is CMS 95623. INCan is CMS 95655. This page is Medical Care and Research, Mérida only. Ampersand alias ALL n=23 stays listed separately; we do not union. First Mérida slug.

Should I add canonical ALL n=24 and ampersand alias ALL n=23?

No. Alias n is listed separately. A unique-study union is not published. The ampersand spelling is the same Mérida campus on the same slug.

Is this INCMNSZ or INCan?

No. Those are Mexico City national-institute intercepts. This page is Mérida, Yucatán.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=24 is still not COFEPRIS authorization. Ethics typically 4–6 weeks; COFEPRIS typically 4–8 weeks after ethics; 2.8-month median start-up on the Mexico hub; registro ~30 working days.

Did bioaccess® run NCT04255433?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico hub: clinical trials in Mexico. Mexico City sibling (do not merge): INCMNSZ. Chihuahua sibling: Scientia Chihuahua.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Instituto de Oncologia de Rosario first-in-human, Instituto de Oncología Rosario clinical trial, IOR Rosario CRO, or “go direct Instituto de Oncología de Rosario,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Oncología de Rosario in Rosario, Argentina, is a real named oncology-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

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

This page is the named Rosario oncology institute. It is not Hospital Provincial del Centenario (CMS 95649), not INECO (CMS 95663), not Fundación de Estudios Clínicos Rosario (CMS 95680), not Sanatorio Parque (CMS 95666), not ICESP (CMS 95642), not Barretos (CMS 95648), not A.C. Camargo (CMS 95691), and not CORI (CMS 95672). Sharing Rosario or sharing an oncology search is not a license to collapse them. Unaccented Instituto de Oncologia de Rosario is a spelling alias on this slug, not a second slug.

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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto de Oncología de Rosario (Rosario, Argentina) — canonical NCT string: ALL interventional n=24; DEVICE n=0. Example NCT IDs: NCT01026142, NCT01572038, NCT01641939.
• Unaccented alias Instituto de Oncologia de Rosario: ALL n=22. Listed separately. Same slug. We do not invent a unique-study union of 24+22. We do not ship a second slug for the missing accent.

Cite canonical ALL n=24 and DEVICE n=0. Cite unaccented ALL n=22 separately. Do not add them. We will not invent a DEVICE n.

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

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

That is the leak: a founder searching “Instituto de Oncología de Rosario clinical trial” or “IOR Rosario FIH” finds canonical ALL n=24 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. A named oncology institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at this Rosario institute is not a Centenario, INECO, Estudios Clínicos, Parque, ICESP, Barretos, Camargo, or CORI file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How ANMAT actually works (the short version)

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

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

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

Do not smear the institute

Instituto de Oncología de Rosario is a serious named Rosario oncology resource on the public registry. ALL n=24 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Centenario, INECO, Estudios Clínicos, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI. 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 Instituto de Oncología de Rosario directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Centenario, INECO, Estudios Clínicos Rosario, Sanatorio Parque, ICESP, Barretos, Camargo, or CORI?

No. Centenario is CMS 95649. INECO is CMS 95663. Estudios Clínicos Rosario is CMS 95680. Sanatorio Parque is CMS 95666. ICESP is CMS 95642. Barretos is CMS 95648. Camargo is CMS 95691. CORI is CMS 95672. This page is Instituto de Oncología de Rosario only. Unaccented ALL n=22 stays listed separately; we do not union.

Should I add canonical ALL n=24 and unaccented ALL n=22?

No. Alias n is listed separately. A unique-study union is not published. The missing accent is the same Rosario campus on the same slug.

Is this ICESP, Barretos, or A.C. Camargo?

No. Those are Brazilian oncology intercepts already live. This page is Rosario, Argentina.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=24 is still not ANMAT authorization.

Did bioaccess® run NCT01026142?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Rosario sibling (do not merge): Fundación de Estudios Clínicos Rosario. São Paulo oncology sibling (do not merge): A.C. Camargo.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Sao Rafael first-in-human, Hospital São Rafael Salvador clinical trial, HSR Salvador CRO, or “go direct Hospital São Rafael,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Sao Rafael in Salvador, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Salvador hospital. It is not Núcleo de Oncologia da Bahia (different NCT string, same city — leftover, not this page). Sharing Salvador is not a license to collapse them. Alias Hospital Sao Rafael – HSR stays on this slug; we do not ship a second slug.

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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Sao Rafael (Salvador, Brazil) — canonical NCT string: ALL interventional n=24; DEVICE n=2. Example NCT IDs: NCT00340834, NCT02003924, NCT03165734.
• Alias Hospital Sao Rafael – HSR (Salvador): ALL n=20. Listed separately. Same slug. We do not invent a unique-study union of 24+20. We do not ship a second slug for the HSR suffix.

Cite canonical ALL n=24 and DEVICE n=2. Cite alias ALL n=20 separately. Do not add them. DEVICE n=2 edges other ALL=24 rows; we will not invent extra DEVICE IDs.

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 São Rafael Salvador clinical trial” or “HSR Salvador FIH” finds canonical ALL n=24 (DEVICE n=2) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Núcleo de Oncologia da Bahia. A named hospital is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Hospital São Rafael is not a Núcleo de Oncologia da Bahia 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

Hospital Sao Rafael is a serious named Salvador hospital on the public registry. ALL n=24 and DEVICE n=2 are registry volume, not a punchline. Do not merge it into Núcleo de Oncologia da Bahia. 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 ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

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

Colombia is still on the map

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

Frequently asked questions

Can I contract Hospital São Rafael 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 Núcleo de Oncologia da Bahia?

No. Núcleo de Oncologia da Bahia is a different NCT string in the same city and is leftover, not this page. Alias Hospital Sao Rafael – HSR ALL n=20 stays listed separately on this slug; we do not union.

Should I add canonical ALL n=24 and HSR alias ALL n=20?

No. Alias n is listed separately. A unique-study union is not published. The HSR suffix is the same Salvador campus on the same slug.

Is this Núcleo de Oncologia da Bahia?

No. That is a different NCT string in Salvador. Same city is not the same hospital. It is leftover, not this page.

Why DEVICE n=2?

That is the ranking-table DEVICE count for the canonical string. It edges other ALL=24 rows. It is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks; CEPs 30 business days; per-patient $20,000–$35,000 as published on the Brazil country page.

Did bioaccess® run NCT00340834?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

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

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 IBPClin as a bioaccess® client.

If you searched IBPClin first-in-human, Instituto Brasil de Pesquisa Clínica clinical trial, IBPClin Rio CRO, or “go direct IBPClin,” you followed a campus string ClinicalTrials.gov still publishes. IBPClin — Instituto Brasil de Pesquisa Clínica in Rio de Janeiro, Brazil, is a real named investigative-institute string on ClinicalTrials.gov. This is the first Rio de Janeiro clinic slug in this intercept series. 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 institute 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 institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Rio investigative institute. It is not CEPIC (CMS 95662), not CPQuali (CMS 95671), not CPCLIN (CMS 95684), and not CEMEC (CMS 95695). It is not Universidade Federal do Rio de Janeiro (this batch, a university string on a different slug). Sharing a Rio de Janeiro search or sharing a “pesquisa clínica” token 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-9-picks-2026-09-02.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• IBPClin – Instituto Brasil de Pesquisa Clínica (Rio de Janeiro, Brazil) — canonical NCT string: ALL interventional n=25; DEVICE n=0. Example NCT IDs: NCT03899259, NCT03952559, NCT04255433.

Cite canonical ALL n=25 and DEVICE n=0. We will not invent an alias union with UFRJ. We will not invent a DEVICE n. First Rio clinic slug; UFRJ stays on its own slug in this batch.

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 “IBPClin Rio first-in-human” or “Instituto Brasil de Pesquisa Clínica clinical trial” finds canonical ALL n=25 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. A named research institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

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

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

How ANVISA actually works (the short version)

Use clinical-trials-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 institute

IBPClin is a serious named Rio investigative institute on the public registry. ALL n=25 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CEPIC, CPQuali, CPCLIN, CEMEC, or UFRJ. 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 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 IBPClin 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 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 institute. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as CEPIC, CPQuali, CPCLIN, CEMEC, or Universidade Federal do Rio de Janeiro?

No. CEPIC is CMS 95662. CPQuali is CMS 95671. CPCLIN is CMS 95684. CEMEC is CMS 95695. UFRJ is a different Rio university string in this batch. This page is IBPClin only. First Rio clinic slug.

Is this UFRJ?

No. Universidade Federal do Rio de Janeiro is a university NCT string on its own slug in this batch. IBPClin is a named investigative institute. Rio is not a merge key.

Is this CEPIC, CPQuali, CPCLIN, or CEMEC?

No. Those are already-live research-center intercepts in other Brazilian cities. This page is IBPClin, Rio de Janeiro.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=25 is still not ANVISA authorization. Combined ethics + ANVISA is typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; published per-patient $20,000–$35,000 on the Brazil country page.

Did bioaccess® run NCT03899259?

No. We cite it as facility evidence for this string. We will not invent a sponsor or a PI. We will not claim bioaccess® ran it.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®