Category: Advantages of Conducting Trials in Latin America

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

If you searched Clinica MEDS La Dehesa Santiago first-in-human, MEDS La Dehesa Clinic clinical trial, Clinica MEDS Dehesa CRO, MEDS La Dehesa Chile CRO, or “go direct Clínica MEDS La Dehesa Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Clínica MEDS La Dehesa SpA in Santiago, Chile, is a real named clinic-campus string on ClinicalTrials.gov (aliases include Clinica MEDS La Dehesa SpA; brand framing also appears as MEDS / MEDS La Dehesa Clinic). It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the named Santiago Clínica MEDS La Dehesa campus. It is DISTINCT from Clínica Alemana de Santiago, Clínica Santa María Santiago, Clínica Colonial Santiago, and Hospital Luis Tisné Santiago. Sharing Santiago metro is not a license to collapse them. Clínica MEDS La Dehesa is not Clínica Alemana. Clínica MEDS La Dehesa is not Clínica Colonial. Clínica MEDS La Dehesa is not Clínica Santa María.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Clinica MEDS La Dehesa SpA (Santiago, Chile) — canonical NCT string: ALL interventional n=3; DEVICE n=3. Example NCT IDs: NCT06073457, NCT06613724, NCT07431723.

Brand or slide marketing that mentions “more than 30 clinical trials underway” is marketing copy — not a ClinicalTrials.gov count and not used as a registry figure on this page.

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

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

That is the leak: a founder searching Clínica MEDS La Dehesa Santiago first-in-human finds ALL n=3 (DEVICE n=3) without finding ISP. A named clinic campus is still a site. An NCT location row is not a CRO. A sports-medicine brand story is still not a CRO.

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

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

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

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

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

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Clínica MEDS La Dehesa is not a Clínica Alemana file, not a Clínica Colonial file, and not a Clínica Santa María 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 ISP actually works (the short version)

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

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

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

Not a critique of the hospital

Clínica MEDS La Dehesa Santiago is a serious named Chilean campus on the public registry — Chile’s first high-complexity sports-medicine clinic brand (surgery, inpatient, and outpatient lines across many specialties) is a real operator story, not a punchline. ALL n=3 and DEVICE n=3 are registry volume. Do not replace registry counts with slide marketing. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Clínica MEDS La Dehesa Santiago 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 ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Clínica Alemana de Santiago or Clínica Colonial Santiago?

No. Clínica Alemana de Santiago and Clínica Colonial Santiago are distinct Santiago campuses. This page is Clínica MEDS La Dehesa / Clinica MEDS La Dehesa SpA only.

Does “more than 30 clinical trials underway” mean ALL n=30 on ClinicalTrials.gov?

No. That figure is brand/slide marketing. This page cites the ClinicalTrials.gov facility string only: ALL interventional n=3; DEVICE n=3 (NCT06073457, NCT06613724, NCT07431723). We will not invent a larger registry count.

Did bioaccess® run NCT06073457, NCT06613724, or NCT07431723?

No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies.

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. Santiago sibling (do not merge): Clínica Alemana de Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study NCT05374993 location-contact fields (LastUpdatePostDate 2026-09-22 location add). Registry contact rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, metrics, or an El Salvador hospital string.

If you searched Virgilio B. Castillero D DDS first-in-human, Virgilio Castillero Panama clinical trial, Dr Castillero Interamericana Panama CRO, Castillero Zero3 Panama, or “go direct Virgilio Castillero,” you followed a named site-contact string ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. Virgilio B. Castillero D, DDS, is a named location CONTACT on that public DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System). A named site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns MINSA, CNBI-registered ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact field is not a CRO.

This page answers the Castillero search. The matching facility page is Universidad Interamericana de Panamá (Panama City). Co-listed site contact on the same NCT location block: Aristides Joel Castillo Vásquez, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc). Castillero and Castillo are kept separate. We do not invent titles beyond the public CONTACT role. We do not invent an El Salvador hospital.

A public bioaccess® TriAgenics case study already describes a Zero3 FIH program framed across Panama and El Salvador. That case study is not a Castillero PI kill page.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Virgilio B. Castillero D, DDS — NCT location CONTACT on Universidad Interamericana de Panamá for NCT05374993.
• Facility: Universidad Interamericana de Panamá, Panama City, Panama.
• Device / sponsor: Zero3 System / TriAgenics Inc; DEVICE_FEASIBILITY; planned enrollment 35; status NOT_YET_RECRUITING on the cited public row.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent enrollment progress. Emailing a named contact confirms interest. It does not open MINSA.

The contact is the contact. The CRO is the operator.

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

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact is not built to own for an investigational device:

• MINSA national file and CNBI-registered ethics packet as the applicant/operator stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a DDS name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.

How MINSA actually works (the short version)

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A contact email is not MINSA clearance.

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

Not a critique of the investigator

Virgilio B. Castillero D, DDS, is a named public NCT site contact on a serious DEVICE_FEASIBILITY row. That is evidence of a person on a campus, not a punchline. Hire the operator. Activate the campus only if it fits.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Virgilio B. Castillero D, DDS directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

This page does not invent a new NCT-action claim for this window. See the public TriAgenics case study for the published Zero3 FIH program story. That page is not this PI kill page.

Is Castillero the same page as Castillo or Universidad Interamericana?

No. Aristides Joel Castillo Vásquez, DDS, is a separate co-listed NCT location CONTACT. Universidad Interamericana de Panamá is the facility page. The three pages are distinct.

Should I invent an El Salvador hospital because the case study mentions El Salvador?

No. NCT05374993 lists Universidad Interamericana de Panamá in Panama. We do not invent an El Salvador hospital string on this page.

Next step

If the search that brought you here was this DDS name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Universidad Interamericana de Panamá site page (same NCT). Related case study (not this kill page): TriAgenics case study.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study NCT05374993 location-contact fields (LastUpdatePostDate 2026-09-22 location add). Registry contact rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, metrics, or an El Salvador hospital string.

If you searched Aristides Joel Castillo Vásquez DDS first-in-human, Aristides Castillo Panama clinical trial, Dr Castillo Interamericana Panama CRO, Castillo Zero3 Panama, or “go direct Aristides Joel Castillo Vásquez,” you followed a named site-contact string ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. Aristides Joel Castillo Vásquez, DDS, is a named location CONTACT on that public DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System). A named site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns MINSA, CNBI-registered ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact field is not a CRO.

This page answers the Castillo search. The matching facility page is Universidad Interamericana de Panamá (Panama City). Co-listed site contact on the same NCT location block: Virgilio B. Castillero D, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc). Castillo and Castillero are kept separate. We do not invent titles beyond the public CONTACT role. We do not invent an El Salvador hospital.

A public bioaccess® TriAgenics case study already describes a Zero3 FIH program framed across Panama and El Salvador. That case study is not a Castillo PI kill page.

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

Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

• Name: Aristides Joel Castillo Vásquez, DDS — NCT location CONTACT on Universidad Interamericana de Panamá for NCT05374993.
• Facility: Universidad Interamericana de Panamá, Panama City, Panama.
• Device / sponsor: Zero3 System / TriAgenics Inc; DEVICE_FEASIBILITY; planned enrollment 35; status NOT_YET_RECRUITING on the cited public row.

We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent enrollment progress. Emailing a named contact confirms interest. It does not open MINSA.

The contact is the contact. The CRO is the operator.

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

• Discuss clinical interest and whether a protocol fits their service line.
• Point toward institutional ethics calendars and campus research rules.
• Help estimate local visit and procedure effort for cases they will run.

What a named contact is not built to own for an investigational device:

• MINSA national file and CNBI-registered ethics packet as the applicant/operator stack.
• Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
• Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
• Multi-country optionality if the indication later needs another Latin American country.

Going direct to a DDS name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.

How MINSA actually works (the short version)

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A contact email is not MINSA clearance.

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

Not a critique of the investigator

Aristides Joel Castillo Vásquez, DDS, is a named public NCT site contact on a serious DEVICE_FEASIBILITY row. That is evidence of a person on a campus, not a punchline. Hire the operator. Activate the campus only if it fits.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I email Aristides Joel Castillo Vásquez, DDS directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

This page does not invent a new NCT-action claim for this window. See the public TriAgenics case study for the published Zero3 FIH program story. That page is not this PI kill page.

Is Castillo the same page as Castillero or Universidad Interamericana?

No. Virgilio B. Castillero D, DDS, is a separate co-listed NCT location CONTACT. Universidad Interamericana de Panamá is the facility page. The three pages are distinct.

Should I invent an El Salvador hospital because the case study mentions El Salvador?

No. NCT05374993 lists Universidad Interamericana de Panamá in Panama. We do not invent an El Salvador hospital string on this page.

Next step

If the search that brought you here was this DDS name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Universidad Interamericana de Panamá site page (same NCT). Related case study (not this kill page): TriAgenics case study.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from ClinicalTrials.gov study NCT05374993 (LastUpdatePostDate 2026-09-22 location add; status NOT_YET_RECRUITING as of that public row) and published bioaccess® country pages. Registry location rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We name only the facility string and site-contact names those public NCT fields support. We do not invent an El Salvador hospital string (none appears on this NCT). We do not invent emails or metrics.

If you searched Universidad Interamericana de Panamá first-in-human, Universidad Interamericana Panama clinical trial, Interamericana Panama CRO, TriAgenics Zero3 Panama site, Universidad Interamericana de Panama NCT05374993, or “go direct Universidad Interamericana de Panamá,” you followed a campus string ClinicalTrials.gov now publishes on NCT05374993. Universidad Interamericana de Panamá in Panama City, Panama, is a real named university-campus string on that DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System; planned enrollment 35). It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns MINSA, CNBI-registered 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 campus or the named site contacts still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Panama City Universidad Interamericana de Panamá campus for the public Zero3 / TriAgenics location string. It is DISTINCT from Hospital Punta Pacífica Panama City, Hospital Paitilla Panama City, The Panama Clinic, and CEVAXIN. Sharing Panama City is not a license to collapse them. Universidad Interamericana de Panamá is not Hospital Punta Pacífica. Universidad Interamericana de Panamá is not Hospital Paitilla. Universidad Interamericana de Panamá is not The Panama Clinic.

A separate public bioaccess® TriAgenics case study already describes a Zero3 first-in-human program framed across Panama and El Salvador. That page is a case study. It is not a Universidad Interamericana site page, and it is not a license to invent an El Salvador hospital string on this page — ClinicalTrials.gov does not list an El Salvador facility on NCT05374993. This draft cites the Panama location row only.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On the public NCT05374993 row (LastUpdatePostDate 2026-09-22 location add), this campus sits here:

• Universidad Interamericana de Panamá (Panama City, Panama) — public NCT location string on NCT05374993 (DEVICE_FEASIBILITY; Zero3 System; TriAgenics Inc; planned enrollment 35; overall status NOT_YET_RECRUITING on that public row). Named site contacts on the same location block (public NCT fields): Aristides Joel Castillo Vásquez, DDS; Virgilio B. Castillero D, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc).

This page uses only that single location row and those named NCT contact fields. We do not invent ALL/DEVICE ranks for this campus — the 1 September 2026 LATAM facility sweep does not carry this string as a multi-study campus.

That NCT ID is how a sponsor searching the university name, the Zero3 System, or the named DDS contacts lands on a campus without landing on an operator. We cite it as facility evidence. We will not invent additional principal investigators. We will not invent enrollment, clock, or cost metrics beyond what published bioaccess® Panama pages already state for the country stack.

That is the leak: a founder searching Universidad Interamericana de Panamá first-in-human, TriAgenics Panama, or Zero3 Panama site finds a DEVICE_FEASIBILITY location row without finding MINSA. A named university campus is still a site. An NCT location row is not a CRO.

What the public NCT actually says (facts only)

Public brief title: a first-in-human study of a novel 3rd molar tooth bud ablation procedure. Intervention type DEVICE; intervention name Zero3 System; lead sponsor TriAgenics Inc. Design on the public row: single-arm prospective, non-randomized; phases N/A; planned enrollment 35. Eligibility ages on the public row: 8 to 12 years. Primary outcome measure on the public row: incidence of wound healing and adverse events (90 days). Status on the cited pull: NOT_YET_RECRUITING. We will not invent timing, enrollment progress, or site activation claims beyond that public status.

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

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

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

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

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

• MINSA. MINSA is the national file for an investigational device in Panama. CNBI-registered ethics still has to sit. A hallway conversation on this campus is not that stack. Early-feasibility on the live Panama blogs is ethics-committee-driven — not an INVIMA/ANVISA-style second national device step. We will not invent a new Panamanian clock on this page. A hallway conversation at Universidad Interamericana de Panamá is not a Hospital Paitilla file and is not The Panama Clinic file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a site-contact 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-campus MSA will not stretch. The public TriAgenics case study already frames a two-country program story; this page still does not invent an El Salvador hospital string absent from NCT05374993.

Going direct to this campus — or emailing the DDS names ClinicalTrials.gov lists as location contacts — is how you confirm a room. It is not how you open an investigational file.

How MINSA actually works (the short version)

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this university is not MINSA clearance.

Ask for a protocol-specific calendar. A campus email is not MINSA 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.

Not a critique of the campus

Universidad Interamericana de Panamá is a serious named Panamanian campus on the public registry for NCT05374993. A DEVICE_FEASIBILITY location row is registry evidence, not a punchline. Name the NCT site contacts as public fields. We do not invent additional investigators. 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 MINSA / 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Universidad Interamericana de Panamá directly for a device FIH?

You can try. The campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

This page does not invent a new NCT-action claim for this window. A public bioaccess® TriAgenics / Zero3 case study already describes FIH work framed across Panama and El Salvador. That case study is not this facility kill page. We cite NCT05374993’s Panama location row as facility evidence for Universidad Interamericana de Panamá. We do not invent an El Salvador hospital string absent from that NCT.

Is this the same page as the TriAgenics case study?

No. bioaccessla.com/case-studies/triagenics is the public case study. This page is the Universidad Interamericana de Panamá site page for the NCT05374993 location string.

Is this the same page as Hospital Paitilla or The Panama Clinic?

No. Hospital Paitilla is a distinct Panama City campus. The Panama Clinic has its own page and must not be republished here. This page is Universidad Interamericana de Panamá only.

Who are Aristides Joel Castillo Vásquez, DDS and Virgilio B. Castillero D, DDS on this page?

They are the named site contacts ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. We cite those public name fields. We do not invent titles beyond what the NCT prints. Emailing a named site contact is still not a CRO.

Should I invent an El Salvador hospital because the TriAgenics case study mentions El Salvador?

No. NCT05374993’s public locations list Universidad Interamericana de Panamá in Panama City, Panama. This page stays on that row.

Next step

If the search that brought you here was this campus, the Zero3 System, or the named NCT site contacts, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related public case study (not this kill page): TriAgenics case study. Distinct Panama City siblings (do not merge): Hospital Punta Pacífica Panama City, Hospital Paitilla Panama City.

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 Real Hospital Português Recife as a bioaccess® client.

If you searched Real Hospital Portugues Recife first-in-human, Beneficencia Portuguesa Pernambuco clinical trial, Hospital Real Portugues Recife CRO, or “go direct Real Hospital Português Recife,” you followed a campus string ClinicalTrials.gov still publishes. Real Hospital Português de Beneficência em Pernambuco in Recife, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, 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 Recife Real Hospital Português de Beneficência em Pernambuco campus only. It is DISTINCT from Beneficência Portuguesa São Paulo / Real e Benemérita Associação Portuguesa de Beneficência (already published). Sharing a Português / Beneficência name is not a license to merge Recife and São Paulo. Real Hospital Português Recife is not Beneficência Portuguesa SP. Real Hospital Português Recife is not UFPE Recife. Real Hospital Português Recife is not Hospital do Câncer de Pernambuco.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Real Hospital Português de Beneficência em Pernambuco (Recife, Brazil) — canonical NCT string: ALL interventional n=8; DEVICE n=3. Example NCT IDs: NCT03141216, NCT04540302, NCT06096142.

Recife campus only.

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 Real Hospital Português Recife first-in-human finds ALL n=8 (DEVICE n=3) without finding ANVISA. A named hospital campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Real Hospital Português Recife is not a Beneficência Portuguesa São Paulo 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 in 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.

Not a critique of the hospital

Real Hospital Português de Beneficência em Pernambuco Recife is a serious named Brazilian campus on the public registry. ALL n=8 and DEVICE n=3 are registry volume, not a punchline. 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Real Hospital Português Recife directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Beneficência Portuguesa São Paulo?

No. Beneficência Portuguesa / Real e Benemérita Associação Portuguesa de Beneficência São Paulo is already published — different city. This page is the Recife Pernambuco campus only.

Did bioaccess® run NCT03141216?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Recife sibling (do not merge): UFPE Recife.

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 Univás Pouso Alegre as a bioaccess® client.

If you searched Univas Pouso Alegre first-in-human, Universidade Vale do Sapucai clinical trial, Univas CRO, or “go direct Univás Pouso Alegre,” you followed a campus string ClinicalTrials.gov still publishes. Univás in Pouso Alegre, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

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

This page is the named Pouso Alegre Univás campus. It is DISTINCT from Federal University of Santa Maria, Federal University of Bahia Salvador, UFF Niterói, and UFPI / Federal University of Piaui (UFPI Fisioterapia is not covered on this page). Sharing a university / Brazil string is not a license to collapse them. Univás Pouso Alegre is not UFSM. Univás Pouso Alegre is not UFBA. Univás Pouso Alegre is not UFPI.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Univás (Pouso Alegre, Brazil) — canonical NCT string: ALL interventional n=10; DEVICE n=3. Example NCT IDs: NCT03200938, NCT04870294, NCT05270538.

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

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

That is the leak: a founder searching Univás Pouso Alegre first-in-human finds ALL n=10 (DEVICE n=3) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Univás Pouso Alegre is not a UFSM file and is not a UFPI 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 in 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.

Not a critique of the hospital

Univás Pouso Alegre is a serious named Brazilian campus on the public registry. ALL n=10 and DEVICE n=3 are registry volume, not a punchline. 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Univás Pouso Alegre directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Federal University of Santa Maria or Federal University of Piaui?

No. Federal University of Santa Maria is already published. UFPI / Federal University of Piaui Fisioterapia strings are not covered on this page. This page is Univás Pouso Alegre only.

Did bioaccess® run NCT03200938?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil sibling (do not merge): Federal University of Santa Maria.

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 ARCSA, 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 IECED Guayaquil as a bioaccess® client.

If you searched IECED Guayaquil first-in-human, Instituto Ecuatoriano de Enfermedades Digestivas clinical trial, IECED Ecuador CRO, or “go direct IECED Guayaquil,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Ecuatoriano de Enfermedades Digestivas (IECED) in Guayaquil, Ecuador, is a real named institute-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ARCSA file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ARCSA, CEISH 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 Guayaquil IECED campus. English-alias strings for IECED Guayaquil are not listed as separate entries. Sharing Guayaquil / IECED is not a license to multiply pages. IECED is not a Quito National Police UDV string. IECED is not a generic Ecuador fold.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Instituto Ecuatoriano de Enfermedades Digestivas (IECED) (Guayaquil, Ecuador) — canonical NCT string: ALL interventional n=8; DEVICE n=4. Example NCT IDs: NCT05640401, NCT06102980, NCT06264466.

ARCSA: Agencia Nacional de Regulación, Control y Vigilancia Sanitaria.

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 IECED Guayaquil first-in-human finds ALL n=8 (DEVICE n=4) without finding ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria). A named institute campus 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:

• ARCSA. ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) is the national file for an investigational device study in Ecuador. CEISH ethics still has to sit before enrollment. A hallway conversation on this campus is not that stack. Live Ecuador blogs already use study-specific ethics language and 30–90 day submission language; we will not invent a new median here. We do not invent an Ecuadorian legal entity. A hallway conversation at IECED Guayaquil is not an ARCSA / CEISH clearance and is not an English-alias IECED 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 ARCSA actually works (the short version)

Use Clinical Trials in Ecuador. ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) — a decentralized Ministry of Health agency — authorizes clinical trials and classifies devices (I, IIa, IIb, III). Every study also needs written approval from a Human Research Ethics Committee (CEISH — Comité de Ética de Investigación en Seres Humanos) before enrollment. That hub does not invent a new Ecuador day-count; live Ecuador blogs already use study-specific ethics language and 30–90 day submission language under Ministerial Agreement 0075-2017 and later reforms. Ask for a protocol-specific calendar. Commercial sanitary / device classification is a second file. We will not invent PAHO/WHO Level 4 standing for ARCSA. We do not invent an Ecuadorian legal entity on this page. Headline ~30% lower (experience-based) program cost versus typical US baselines is already on that hub — not a campus quote we invent here.

Ask for a protocol-specific calendar. A hospital email is not ARCSA 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.

Not a critique of the hospital

IECED Guayaquil is a serious named Ecuadorian campus on the public registry. ALL n=8 and DEVICE n=4 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator. We do not invent an Ecuadorian legal entity on this page.

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

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ARCSA / 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract IECED Guayaquil 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 ARCSA 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 answers the search; it does not claim the studies.

Is this the same page as Ecuadorian Institute of Digestive Diseases (English alias) or academy tertiary IECED?

No. Those are alias and department strings for the same Guayaquil IECED campus. This page is Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Guayaquil only — do not publish the English alias or academy-tertiary ranks separately.

Did bioaccess® run NCT05640401?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country operator page: clinical trials in Ecuador (ARCSA / CEISH file).

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Luis Tisne Santiago first-in-human, Hospital Santiago Oriente Luis Tisne Brousse clinical trial, Hospital Luis Tisne CRO, or “go direct Hospital Luis Tisné Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Luis Tisné in Santiago, Chile, is a real named hospital-campus string on ClinicalTrials.gov (aliases include Hospital Santiago Oriente Dr. Luis Tisné Brousse). It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

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

This page is the named Santiago Hospital Luis Tisné campus. It is DISTINCT from Hospital Luis Calvo Mackenna Santiago (near-dup flag — different hospital). Do NOT also publish a Hospital Tisne alias rank. Sharing a Luis / Santiago name is not a license to collapse them. Hospital Luis Tisné is not Hospital Luis Calvo Mackenna. Hospital Luis Tisné is not Clínica Colonial. Hospital Luis Tisné is not Clínica Santa María.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Hospital Luis Tisne (Santiago, Chile) — canonical NCT string: ALL interventional n=8; DEVICE n=4. Example NCT IDs: NCT02049983, NCT06432088, NCT06743256.

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 Luis Tisné Santiago first-in-human finds ALL n=8 (DEVICE n=4) without finding ISP. A named hospital campus 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Hospital Luis Tisné is not a Hospital Luis Calvo Mackenna 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 ISP actually works (the short version)

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

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

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

Not a critique of the hospital

Hospital Luis Tisné Santiago is a serious named Chilean campus on the public registry. ALL n=8 and DEVICE n=4 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

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

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

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

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Luis Tisné Santiago directly for a device FIH?

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

Did bioaccess® run the NCT IDs listed here?

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

Is this the same page as Hospital Luis Calvo Mackenna Santiago?

No. Hospital Luis Calvo Mackenna Santiago is a distinct Santiago campus (near-dup flag only). This page is Hospital Luis Tisné / Hospital Santiago Oriente Dr. Luis Tisné Brousse only — do not merge and do not publish a Tisne alias rank.

Did bioaccess® run NCT02049983?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Santiago sibling (do not merge): Clínica Colonial Santiago.

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 Associação Fundo de Incentivo à Pesquisa São Paulo as a bioaccess® client.

If you searched Associacao Fundo de Incentivo a Pesquisa Sao Paulo first-in-human, AFIP Sao Paulo clinical trial, Associacao Fundo Incentivo Pesquisa CRO, or “go direct Associação Fundo de Incentivo à Pesquisa São Paulo,” you followed a campus string ClinicalTrials.gov still publishes. Associação Fundo de Incentivo à Pesquisa (AFIP) in São Paulo, Brazil, is a real named institute/research-foundation campus 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 / CONEP, 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 São Paulo Associação Fundo de Incentivo à Pesquisa campus. It is DISTINCT from Hcor São Paulo, Beneficência Portuguesa São Paulo, Medcin Instituto da Pele, and Passo Fundo campuses that share a Fundo/Passo string in near-dup flags. Sharing São Paulo metro or a Fundo name fragment is not a license to collapse them. AFIP São Paulo is not Hcor. AFIP São Paulo is not Beneficência Portuguesa. AFIP São Paulo is not Instituto Mederi Passo Fundo.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Associação Fundo de Incentivo à Pesquisa (São Paulo, Brazil) — canonical NCT string: ALL interventional n=9; DEVICE n=4. Example NCT IDs: NCT01289392, NCT01289405, NCT01461486.

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 Associação Fundo de Incentivo à Pesquisa São Paulo first-in-human finds ALL n=9 (DEVICE n=4) without finding ANVISA. A named research institute is still a site. An NCT location row is not a CRO.

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

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

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

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

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

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at AFIP São Paulo is not a Hcor file and is not a Beneficência Portuguesa São Paulo 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 in 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.

Not a critique of the hospital

Associação Fundo de Incentivo à Pesquisa São Paulo is a serious named Brazilian campus on the public registry. ALL n=9 and DEVICE n=4 are registry volume, not a punchline. 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Associação Fundo de Incentivo à Pesquisa São Paulo 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 answers the search; it does not claim the studies.

Is this the same page as Hcor São Paulo or Beneficência Portuguesa São Paulo?

No. Hcor São Paulo is already published. Beneficência Portuguesa São Paulo is already published — do not near-dup merge. This page is Associação Fundo de Incentivo à Pesquisa São Paulo only.

Did bioaccess® run NCT01289392?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

If you searched Hospital Paitilla Panama City first-in-human, Paitilla Medical Center clinical trial, Hospital Paitilla CRO, or “go direct Hospital Paitilla Panama City,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Paitilla in Panama City, Panama, is a real named hospital-campus string on ClinicalTrials.gov (alias includes Paitilla Medical Center). It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns MINSA, CNBI-registered 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 Panama City Hospital Paitilla campus. It is DISTINCT from Hospital Punta Pacífica Panama City (also Panama City — keep both; call out distinct), from The Panama Clinic, and from CEVAXIN. Sharing Panama City is not a license to collapse them. Hospital Paitilla is not Hospital Punta Pacífica. Hospital Paitilla is not The Panama Clinic. Hospital Paitilla is not CEVAXIN.

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), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Hospital Paitilla (Panama City, Panama) — canonical NCT string: ALL interventional n=8; DEVICE n=5. Example NCT IDs: NCT00719277, NCT04864652, NCT05542082.

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 Paitilla Panama City first-in-human finds ALL n=8 (DEVICE n=5) without finding MINSA. A named hospital campus 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:

• MINSA. MINSA is the national file for an investigational device in Panama. CNBI-registered ethics still has to sit. A hallway conversation on this campus is not that stack. Early-feasibility on the live Panama blogs is ethics-committee-driven — not an INVIMA/ANVISA-style second national device step. We will not invent a new Panamanian clock on this page. A hallway conversation at Hospital Paitilla is not a Hospital Punta Pacífica file and is not The Panama Clinic 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 MINSA actually works (the short version)

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Ask for a protocol-specific calendar. A hospital email is not MINSA 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.

Not a critique of the hospital

Hospital Paitilla Panama City is a serious named Panamanian campus on the public registry. ALL n=8 and DEVICE n=5 are registry volume, not a punchline. 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 MINSA / 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

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Paitilla Panama City 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 MINSA 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 answers the search; it does not claim the studies.

Is this the same page as Hospital Punta Pacífica or The Panama Clinic?

No. Hospital Punta Pacífica is a distinct Panama City campus. The Panama Clinic has its own page and must not be republished. This page is Hospital Paitilla only.

Did bioaccess® run NCT00719277?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Panama City sibling (do not merge): Hospital Punta Pacífica Panama City.

Julio G. Martinez-Clark, CEO · bioaccess®