Category: Navigating Regulatory Landscapes in Latin America

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

If you searched CEMEDIC first-in-human, CEMEDIC CABA clinical trial, Centro de Especialidades Medicas Villa Luro CRO, or “go direct CEMEDIC,” you followed a campus string ClinicalTrials.gov still publishes. CEMEDIC in Buenos Aires, Argentina, is a real named specialty/research-center 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Buenos Aires specialty center. It is not Centro Médico Viamonte (CMS 95668), not CINME (CMS 95669), not CIPREC (CMS 95641), not Mautalen (CMS 95681), not Hospital Italiano de Buenos Aires (CMS 95620), and not Instituto Alexander Fleming (CMS 95708). Sharing Buenos Aires is not a license to collapse them. Aliases CEMEDIC CABA and CEMEDIC – Centro de Especialidades Medicas Villa Luro 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-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.

• CEMEDIC (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT02594371, NCT04036253, NCT04255433.
• City-label alias CEMEDIC (CABA): ALL n=10. Listed separately. Same slug. We do not invent a unique-study union of 22+10. We do not ship a second slug.
• Neighborhood alias CEMEDIC – Centro de Especialidades Medicas (Villa Luro): ALL n=9. Listed separately. Same slug. No union. No second slug.

Cite canonical ALL n=22 and DEVICE n=0. Cite CABA ALL n=10 and Villa Luro ALL n=9 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 center as a client site.

That is the leak: a founder searching “CEMEDIC first-in-human” or “CEMEDIC Villa Luro clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming. A named specialty center is still a site. An NCT location row is not a CRO.

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

A named center 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 center 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 center 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 CEMEDIC is not a Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming 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 center

CEMEDIC is a serious named Buenos Aires specialty/research center on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into Viamonte, CINME, CIPREC, Mautalen, HIBA, or Fleming. 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 CEMEDIC directly for a device FIH?

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

Is this the same page as Viamonte, CINME, CIPREC, Mautalen, HIBA, or Instituto Alexander Fleming?

No. Viamonte is CMS 95668. CINME is CMS 95669. CIPREC is CMS 95641. Mautalen is CMS 95681. HIBA is CMS 95620. Fleming is CMS 95708. This page is CEMEDIC, Buenos Aires only. CABA ALL n=10 and Villa Luro ALL n=9 stay listed separately; we do not union.

Should I add canonical ALL n=22, CABA ALL n=10, and Villa Luro ALL n=9?

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

Is this CINME, CIPREC, Viamonte, or Mautalen?

No. Those are already-live Buenos Aires intercepts. This page is CEMEDIC only.

Is this Hospital Italiano or Instituto Alexander Fleming?

No. HIBA is CMS 95620. Fleming is CMS 95708. Sharing Buenos Aires is not a merge.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 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 NCT02594371?

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 siblings (do not merge): CINME, CIPREC, Centro Médico Viamonte, Instituto Alexander Fleming.

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Aleman Buenos Aires first-in-human, Hospital Alemán CABA clinical trial, Hospital Alemán CRO Argentina, or “go direct Hospital Alemán Buenos Aires,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Aleman in Buenos Aires, Argentina, 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 ANMAT file.

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

This page is the named Buenos Aires hospital. It is not Hospital Alemão Oswaldo Cruz (CMS 95635, São Paulo), not Hospital Italiano de Buenos Aires (CMS 95620), and not Hospital Británico (CMS 95654). Sharing “Alemán / Alemão” or sharing Buenos Aires is not a license to collapse them. City-label aliases Hospital Aleman Caba / CABA / Ciudad Autónoma stay 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.

• Hospital Aleman (Buenos Aires, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT00496002, NCT00496158, NCT00940095.
• City-label alias Hospital Aleman (Caba): ALL n=11. Listed separately. Same slug. No union.
• City-label alias Hospital Aleman (CABA): ALL n=10. Listed separately. Same slug. No union. A CABA DEVICE n=6 label is listed separately as well; we do not invent a unique-study union with canonical DEVICE n=0.

Cite canonical ALL n=22 and DEVICE n=0. Cite Caba ALL n=11 and CABA ALL n=10 separately. Do not add them. Ciudad Autónoma city-label strings stay on this slug. We do not clone CMS 95635.

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 Alemán Buenos Aires first-in-human” or “Hospital Aleman CABA clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on Hospital Alemão Oswaldo Cruz, HIBA, or Británico. 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:

• 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 Hospital Alemán is not an Oswaldo Cruz São Paulo file, not a HIBA file, and not a Británico 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 hospital

Hospital Aleman is a serious named Buenos Aires hospital on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n for the canonical string. Do not merge it into Hospital Alemão Oswaldo Cruz, HIBA, or Británico. 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 Hospital Alemán Buenos Aires directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Alemão Oswaldo Cruz, Hospital Italiano de Buenos Aires, or Hospital Británico?

No. Hospital Alemão Oswaldo Cruz is CMS 95635 in São Paulo. HIBA is CMS 95620. Británico is CMS 95654. This page is Hospital Aleman, Buenos Aires only. Caba ALL n=11 and CABA ALL n=10 stay listed separately; we do not union.

Should I add canonical ALL n=22, Caba ALL n=11, and CABA ALL n=10?

No. Alias n is listed separately. A unique-study union is not published. Caba / CABA / Ciudad Autónoma city-label strings stay on this slug.

Is this Hospital Alemão Oswaldo Cruz?

No. That is CMS 95635 in São Paulo. German-hospital naming in another country is not a merge. Overlap on that live page is not a reason to clone it here.

Why DEVICE n=0 on the canonical string?

That is the ranking-table DEVICE count for Hospital Aleman, Buenos Aires. A separate CABA DEVICE n=6 label is listed separately; we do not union it onto canonical DEVICE n=0. ALL n=22 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 NCT00496002?

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 siblings (do not merge): Hospital Italiano de Buenos Aires, Hospital Británico. São Paulo sibling (do not merge): Hospital Alemão Oswaldo Cruz.

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 Centro Médico San Roque Tucumán as a bioaccess® client.

If you searched Centro Medico San Roque Tucuman first-in-human, San Roque San Miguel de Tucumán clinical trial, Centro Médico San Roque CRO, or “go direct Centro Médico San Roque Tucumán,” you followed a campus string ClinicalTrials.gov still publishes. Centro Medico San Roque in San Miguel de Tucumán, Argentina, is a real named private medical-center 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 center 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 center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Tucumán private medical center. It is not Centro de Investigaciones Médicas Tucumán (CMS 95682), not Hospital San Roque Córdoba (CMS 95686; NCT overlap 0), and not Centro Médico Privado de Reumatología Tucumán (batch 5, already live). Sharing Tucumán or sharing “San Roque” is not a license to collapse them. Córdoba is a different city.

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

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

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.

• Centro Medico San Roque (San Miguel de Tucumán, Argentina) — canonical NCT string: ALL interventional n=22; DEVICE n=0. Example NCT IDs: NCT00388726, NCT00428220, NCT00465491.

Cite canonical ALL n=22 and DEVICE n=0. We will not invent an alias union with CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. We will not invent a DEVICE n. NCT overlap with Hospital San Roque Córdoba is 0.

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 center as a client site.

That is the leak: a founder searching “Centro Médico San Roque Tucumán first-in-human” or “San Roque San Miguel de Tucumán clinical trial” finds canonical ALL n=22 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. A named medical center is still a site. An NCT location row is not a CRO.

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

A named center 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 center 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 center 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 Centro Médico San Roque is not a CIM Tucumán file, not a Hospital San Roque Córdoba file, and not a reumatología-Tucumán 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 center

Centro Medico San Roque is a serious named Tucumán private medical center on the public registry. ALL n=22 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán. 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 Centro Médico San Roque Tucumán directly for a device FIH?

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

Is this the same page as CIM Tucumán, Hospital San Roque Córdoba, or Centro Médico Privado de Reumatología Tucumán?

No. CIM Tucumán is CMS 95682. Hospital San Roque Córdoba is CMS 95686 (NCT overlap 0). Centro Médico Privado de Reumatología Tucumán is already live from batch 5. This page is Centro Medico San Roque, San Miguel de Tucumán only.

Is this Hospital San Roque Córdoba?

No. Hospital San Roque Córdoba is CMS 95686. NCT overlap with this Tucumán string is 0. “San Roque” in the name is not a merge key. Córdoba versus Tucumán is the filter.

Is this CIM Tucumán?

No. CIM Tucumán is CMS 95682. Same city is not the same NCT string.

Is this Centro Médico Privado de Reumatología Tucumán?

No. That intercept is already live from batch 5. This page is Centro Medico San Roque.

Why DEVICE n=0?

That is the ranking-table DEVICE count for this string. We will not invent a DEVICE ranking. ALL n=22 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 NCT00388726?

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. Tucumán siblings (do not merge): CIM Tucumán, Centro Médico Privado de Reumatología Tucumán. Córdoba sibling: Hospital San Roque Córdoba.

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 Instituto de Pesquisa Clínica de Campinas as a bioaccess® client.

If you searched Instituto de Pesquisa clinica de Campinas first-in-human, IPECC Campinas clinical trial, Pesquisa Clínica Campinas CRO, or “go direct Instituto de Pesquisa Clínica de Campinas,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Pesquisa clinica de Campinas in Campinas, Brazil, is a real named investigative-institute 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 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 Campinas investigative institute. It is not University of Campinas / UNICAMP (CMS 95706) and it is not Centro de Pesquisa São Lucas Campinas (CMS 95689). Sharing Campinas is not a license to collapse them. Aliases Instituto de Pesquisa Clínica de Campinas, Instituto de Pesquisa Clinica de Campinas, and IPECC – Instituto de Pesquisa Clínica de Campinas 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-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 Pesquisa clinica de Campinas (Campinas, Brazil) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT04184622, NCT04255433, NCT04657003.
• Accented alias Instituto de Pesquisa Clínica de Campinas: ALL n=20. Listed separately. Same slug. No union.
• Spelling alias Instituto de Pesquisa Clinica de Campinas: ALL n=9. Listed separately. Same slug. No union.
• Short alias IPECC – Instituto de Pesquisa Clínica de Campinas: ALL n=8. Listed separately. Same slug. No union.

Cite canonical ALL n=23 and DEVICE n=0. Cite each alias n separately. Do not add 23+20+9+8. We will not invent a DEVICE n. We do not clone UNICAMP or São Lucas onto 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 institute as a client site.

That is the leak: a founder searching “IPECC Campinas first-in-human” or “Instituto de Pesquisa Clínica de Campinas clinical trial” finds canonical ALL n=23 (DEVICE n=0) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on UNICAMP or Centro de Pesquisa São Lucas Campinas. A named investigative 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 this Campinas institute is not a UNICAMP university file and is not a São Lucas Campinas research-center 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

Instituto de Pesquisa clinica de Campinas is a serious named Campinas investigative institute on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into UNICAMP or Centro de Pesquisa São Lucas Campinas. 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 Instituto de Pesquisa Clínica de Campinas 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 University of Campinas / UNICAMP or Centro de Pesquisa São Lucas Campinas?

No. UNICAMP is CMS 95706. São Lucas Campinas is CMS 95689. This page is Instituto de Pesquisa clinica de Campinas only. Accented ALL n=20, Clinica ALL n=9, and IPECC ALL n=8 stay listed separately; we do not union.

Should I add ALL n=23, accented n=20, Clinica n=9, and IPECC n=8?

No. Alias n is listed separately. A unique-study union is not published. Accents, the missing accent, and the IPECC prefix stay on this slug.

Is this UNICAMP?

No. University of Campinas is CMS 95706, a university NCT string. This page is a named investigative institute. Campinas is not a merge key.

Is this Centro de Pesquisa São Lucas Campinas?

No. São Lucas Campinas is CMS 95689. This page is Instituto de Pesquisa clinica de Campinas.

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 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 NCT04184622?

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 siblings (do not merge): University of Campinas, 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 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 Mar del Plata as a bioaccess® client.

If you searched Instituto de Investigaciones Clinicas Mar del Plata first-in-human, IIC Mar del Plata clinical trial, IIC MdP CRO Argentina, or “go direct Instituto de Investigaciones Clínicas Mar del Plata,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Investigaciones Clínicas Mar del Plata in Mar del Plata, 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 IIC Mar del Plata organization. It is a different organization from Centro de Investigaciones Médicas Mar del Plata (CMS 95699). NCT overlap is 1 on this canonical string. Link it as a sibling; do not clone CMS 95699. It is city-distinct from Instituto de Investigaciones Clínicas Quilmes (this batch) and from leftover IIC Rosario / Córdoba strings (not this page). Unaccented Instituto de Investigaciones Clinicas Mar del Plata 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-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 Clínicas Mar del Plata (Mar del Plata, Argentina) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT01885078, NCT03987919, NCT04184622.
• Unaccented spelling alias Instituto de Investigaciones Clinicas Mar del Plata: ALL n=22. Listed separately. Same slug. We do not invent a unique-study union of 23+22. We do not ship a second slug for the missing accent.

Cite canonical ALL n=23 and DEVICE n=0. Cite unaccented ALL n=22 separately. Do not add them. Do not clone CMS 95699 counts onto this page. 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 “IIC Mar del Plata first-in-human” or “Instituto de Investigaciones Clínicas Mar del Plata clinical trial” finds canonical ALL n=23 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIM MdP (CMS 95699), IIC Quilmes, leftover IIC Rosario, 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 at IIC Mar del Plata is not a CIM MdP file, not an IIC Quilmes 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 Clínicas Mar del Plata is a serious named Mar del Plata research institute on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not clone CMS 95699. Do not merge it into CIM MdP, IIC Quilmes, leftover IIC Rosario, 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 Mar del Plata 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 Centro de Investigaciones Médicas Mar del Plata, IIC Quilmes, CIPREC, or CINME?

No. CIM MdP is CMS 95699 — a different organization (NCT overlap 1 on this canonical string). Link it; do not merge it. IIC Quilmes is a different city on its own slug in this batch. CIPREC is CMS 95641. CINME is CMS 95669. Unaccented ALL n=22 stays listed separately; we do not union.

Should I add canonical ALL n=23 and unaccented ALL n=22?

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

Is this Centro de Investigaciones Médicas Mar del Plata?

No. CIM MdP is CMS 95699, a different organization. NCT overlap is 1. We link that page as a sibling. We do not clone it.

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 ANMAT authorization. Trial versus registro remain different petitions.

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. Sibling (do not merge): Centro de Investigaciones Médicas Mar del Plata. Quilmes sibling in this batch (do not merge): Instituto de Investigaciones Clínicas Quilmes.

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 Clinstile Mexico City as a bioaccess® client.

If you searched Clinstile first-in-human, Clinstile S.A. de C.V. Mexico City clinical trial, Clinstile CRO Mexico, or “go direct Clinstile Mexico City,” you followed a campus string ClinicalTrials.gov still publishes. Clinstile, S.A. de C.V. in Mexico City is a real named CDMX research-clinic legal-name string on ClinicalTrials.gov. Same class as FAICIC and Scientia. 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 CDMX legal-name row only: Clinstile, S.A. de C.V. with city Mexico City. Other NCT strings — Clinstile, S.A. de C.V. with city México (ALL n=11), Cuauhtémoc (ALL n=2), and Clinstile S.A de C.V. Mexico City (missing comma; ALL n=9) — are other NCT strings, not this campus row. We do not merge those strings onto this slug as if they were one NCT key. We do not ship a second slug for them. This page is not INCMNSZ (CMS 95623), not INCan (CMS 95655), not Clinical Research Institute Tlalnepantla (CMS 95683), not Scientia Chihuahua (CMS 95692), and not FAICIC Veracruz (CMS 95670).

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.

• Clinstile, S.A. de C.V. (Mexico City, Mexico) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT02070978, NCT02760407, NCT02760433.
• Other NCT string Clinstile, S.A. de C.V. (México): ALL n=11. Listed separately as another NCT string, not this campus row. We do not union 23+11. We do not ship a second slug.
• Other NCT string Cuauhtémoc: ALL n=2. Listed separately. Not this campus row. No union. No second slug.
• Other NCT string Clinstile S.A de C.V. (Mexico City, missing comma): ALL n=9. Listed separately. Not this campus row. No union. No second slug.

Cite canonical ALL n=23 and DEVICE n=0. Cite the other-city / punctuation strings 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 clinic as a client site.

That is the leak: a founder searching “Clinstile Mexico City first-in-human” or “Clinstile S.A. de C.V. 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 INCMNSZ, INCan, CRI Tlalnepantla, Scientia, or FAICIC. A named research 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 at this CDMX legal-name row is not an INCMNSZ, INCan, Tlalnepantla, Scientia, or FAICIC 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

Clinstile, S.A. de C.V. (Mexico City) is a serious named CDMX research clinic on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge other-city Clinstile strings onto this row. Do not merge it into INCMNSZ, INCan, CRI Tlalnepantla, Scientia, or FAICIC. 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 Clinstile Mexico City 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 other-city Clinstile strings, INCMNSZ, INCan, CRI Tlalnepantla, Scientia, or FAICIC?

No. México ALL n=11, Cuauhtémoc ALL n=2, and missing-comma Mexico City ALL n=9 are other NCT strings, not this campus row and not a second slug. INCMNSZ is CMS 95623. INCan is CMS 95655. CRI Tlalnepantla is CMS 95683. Scientia is CMS 95692. FAICIC is CMS 95670. This page is the CDMX legal-name row only.

Should I add canonical ALL n=23, México ALL n=11, Cuauhtémoc ALL n=2, and missing-comma ALL n=9?

No. Those other strings are listed separately as other NCT strings, not this campus row. A unique-study union is not published. We do not ship a second slug for them either.

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 NCT02070978?

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. Class siblings (do not merge): FAICIC Veracruz, 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 Clínica Viedma as a bioaccess® client.

If you searched Clinica Viedma first-in-human, Clínica Viedma clinical trial, Viedma CRO Argentina Río Negro, or “go direct Clínica Viedma,” you followed a campus string ClinicalTrials.gov still publishes. Clinica Viedma in Viedma, Argentina, is a real named clinic string on ClinicalTrials.gov. This is the first Río Negro slug in this intercept series. 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 clinic 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 clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Viedma clinic. It is not CIPREC (CMS 95641), not Hospital Italiano de Buenos Aires (CMS 95620), and not Hospital Provincial del Centenario Rosario (CMS 95649). Sharing an Argentine clinic search is not a license to collapse them. Viedma is not Buenos Aires and is not Rosario. Alias Clinica Viedma S.A. 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.

• Clinica Viedma (Viedma, Argentina) — canonical NCT string: ALL interventional n=23; DEVICE n=0. Example NCT IDs: NCT00428220, NCT02268045, NCT02594371.
• Legal-suffix alias Clinica Viedma S.A.: ALL n=7. Listed separately. Same slug. We do not invent a unique-study union of 23+7. We do not ship a second slug for the S.A. suffix.

Cite canonical ALL n=23 and DEVICE n=0. Cite alias ALL n=7 separately. Do not add them. We will not invent a DEVICE n. First Río Negro 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 “Clínica Viedma first-in-human” or “Viedma clinical trial Argentina” finds canonical ALL n=23 (DEVICE n=0) without finding ANMAT, ethics, import, insurance, or 21 CFR 812.28 — and without landing on CIPREC, HIBA, or Centenario Rosario. 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:

• 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 Viedma is not a CIPREC file, not a HIBA file, and not a Rosario Centenario 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 clinic

Clinica Viedma is a serious named Viedma clinic on the public registry. ALL n=23 is registry volume, not a punchline. Do not invent a DEVICE n. Do not merge it into CIPREC, HIBA, or Centenario Rosario. 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 Clínica Viedma 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 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 clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

Is this the same page as CIPREC, Hospital Italiano de Buenos Aires, or Hospital Provincial del Centenario Rosario?

No. CIPREC is CMS 95641. HIBA is CMS 95620. Centenario Rosario is CMS 95649. This page is Clinica Viedma only. First Río Negro slug. S.A. alias ALL n=7 stays listed separately; we do not union.

Should I add canonical ALL n=23 and S.A. alias ALL n=7?

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

Is this the first Río Negro intercept?

Yes. This slug is the Viedma named-clinic intercept. Do not invent a second Río Negro slug from a spelling variant we did not publish.

Is this CIPREC, HIBA, or Centenario Rosario?

No. Those are already-live intercepts in Buenos Aires or Rosario. Viedma is a different city and a different NCT string.

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 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 NCT00428220?

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. CIPREC sibling: CIPREC.

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 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®