Category: First-in-Human

Names and roles cited from ClinicalTrials.gov study record NCT05695989 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Julio Jimenez MD first-in-human, Julio Jimenez Chile clinical trial, Dr Jimenez Hospital Tisne CRO, Levita dual robotic arm Chile PI, Luis Tisné surgical investigator, or “go direct Julio Jimenez, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical / robotic-platform accessory device investigation (dual robotic arm accessory with Levita magnetic surgical system on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Jimenez search. Matching facility page: Hospital Luis Tisné Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Julio Jimenez, MD.
• NCT05695989 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Julio Jimenez, MD” / Hospital Tisne (safety and feasibility of the dual robotic arm accessory with the Levita magnetic surgical system on the public brief title).
• Affiliation on this page: Hospital Tisne from the public NCT row above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Julio Jimenez, MD, is a named public NCT principal investigator on a serious DEVICE safety-and-feasibility row at Hospital Tisne for the Levita dual robotic arm accessory program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Julio Jimenez, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT05695989?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Julio Jimenez, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Julio Jimenez, MD” / Hospital Tisne on NCT05695989.

Is this the same page as Hospital Luis Tisné Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Luis Tisné Santiago and this page Julio Jimenez, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Luis Tisné Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT01346943 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Albrecht Kramer MD first-in-human, Albrecht Kramer Chile clinical trial, Dr Kramer Universidad Catolica CRO, Altura AAA endograft Chile PI, UC Católica vascular investigator, or “go direct Albrecht Kramer, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is vascular / endovascular device investigation (Altura AAA endograft safety and feasibility on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Kramer search. Matching facility page: Hospital Clínico Universidad Católica Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Albrecht Kramer, MD.
• NCT01346943 — UNKNOWN status DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Albrecht Kramer, MD” / Pontificia Universidad Catolica de Chile (Altura abdominal aortic aneurysm endograft safety and feasibility study on the public brief title).
• Affiliation on this page: Pontificia Universidad Catolica De Chile from the public NCT row above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Albrecht Kramer, MD, is a named public NCT principal investigator on a serious DEVICE safety-and-feasibility row at Pontificia Universidad Catolica de Chile for the Altura AAA endograft program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Albrecht Kramer, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT01346943?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Albrecht Kramer, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Albrecht Kramer, MD” / Pontificia Universidad Catolica de Chile on NCT01346943.

Is this the same page as Hospital Clínico Universidad Católica Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Clínico Universidad Católica and this page Albrecht Kramer, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Clínico Universidad Católica Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT06600191 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Gonzalo Javier Martinez Rodriguez first-in-human, Gonzalo Martinez Rodriguez Chile clinical trial, Capstan TMVR Chile contact, Pontificia Universidad Católica FIH investigator, UC Católica Capstan site contact, or “go direct Gonzalo Javier Martinez Rodriguez,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / transcatheter mitral device investigation (Capstan Medical TMVR FIH on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Martinez search. Matching facility page: Hospital Clínico Universidad Católica Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Gonzalo Javier Martinez Rodriguez (as published on ClinicalTrials.gov — we do not invent an MD suffix).
• NCT06600191 — RECRUITING DEVICE row; location CONTACT “Gonzalo Javier Martinez Rodriguez” / Pontificia Universidad Católica de Chile (Capstan Medical TMVR Study: FIH on the public brief title).
• Affiliation on this page: Pontificia Universidad Católica de Chile from the public NCT row above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Gonzalo Javier Martinez Rodriguez is a named public NCT site contact on a serious DEVICE first-in-human row at Pontificia Universidad Católica de Chile for the Capstan TMVR program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Gonzalo Javier Martinez Rodriguez directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT06600191?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Gonzalo Javier Martinez Rodriguez?

ClinicalTrials.gov cites location CONTACT “Gonzalo Javier Martinez Rodriguez” at Pontificia Universidad Católica de Chile on NCT06600191. We do not invent an OverallOfficial or MD title beyond that public CONTACT string.

Is this the same page as Hospital Clínico Universidad Católica Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Clínico Universidad Católica and this page Gonzalo Javier Martinez Rodriguez.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Clínico Universidad Católica Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT06200896 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Juan Contreras MD first-in-human, Juan Contreras Chile clinical trial, Dr Contreras Colonial Chile CRO, magnetic anastomosis EFS Chile PI, Clínica Colonial investigator, or “go direct Juan Contreras, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is digestive / surgical anastomosis device investigation (self-forming magnetic anastomosis early feasibility on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Contreras search. Matching facility page: Clínica Colonial Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Juan Contreras, MD.
• NCT06200896 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Juan Contreras, MD” with Chile facility string Clínica Colonial Hospital on the study (early feasibility assessment of a self-forming magnetic anastomosis device and delivery system on the public brief title).
• Affiliation on this page: Clínica Colonial Hospital from the public NCT row above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Juan Contreras, MD, is a named public NCT principal investigator on a serious DEVICE early-feasibility row tied to Clínica Colonial Hospital. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Juan Contreras, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT06200896?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Juan Contreras, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Juan Contreras, MD” on NCT06200896 with facility string Clínica Colonial Hospital.

Is this the same page as Clínica Colonial Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica Colonial Santiago and this page Juan Contreras, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Clínica Colonial Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT04861805 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Gabriel Maluenda MD first-in-human, Gabriel Maluenda Chile clinical trial, Dr Maluenda San Borja Arriarán CRO, Vienna TAVR Chile PI, San Borja FIH investigator, or “go direct Gabriel Maluenda, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / interventional cardiology device investigation (Vienna transcatheter aortic program on the public brief title). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Maluenda search. Matching facility page: Hospital Clínico San Borja Arriarán Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Gabriel Maluenda, MD.
• NCT04861805 — RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR, and OverallOfficial PRINCIPAL_INVESTIGATOR “Gabriel Maluenda, MD” / Hospital Clínico San Borja Arriarán (Vienna transcatheter self-expandable aortic valve SE system pivotal study on the public brief title).
• Affiliation on this page: Hospital Clínico San Borja Arriarán from the public NCT row above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Gabriel Maluenda, MD, is a named public NCT principal investigator and site contact on a serious DEVICE row at Hospital Clínico San Borja Arriarán for the Vienna aortic program. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Gabriel Maluenda, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT04861805?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Gabriel Maluenda, MD?

ClinicalTrials.gov cites CONTACT, location PRINCIPAL_INVESTIGATOR, and OverallOfficial PRINCIPAL_INVESTIGATOR roles at Hospital Clínico San Borja Arriarán on NCT04861805.

Is this the same page as Hospital Clínico San Borja Arriarán Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Clínico San Borja Arriarán Santiago and this page Gabriel Maluenda, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Clínico San Borja Arriarán Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study records NCT04861805 and NCT05871983 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Osvaldo Perez MD first-in-human, Osvaldo Perez Chile clinical trial, Dr Perez Higueras Talcahuano CRO, Vienna TAVR Chile PI, Munich TMVR Talcahuano investigator, or “go direct Osvaldo Perez, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / interventional cardiology device investigation (transcatheter aortic and mitral programs on the public brief titles). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Perez search. Matching facility page: Hospital Las Higueras Talcahuano. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Osvaldo Perez, MD.
• NCT04861805 — RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR, and OverallOfficial PRINCIPAL_INVESTIGATOR “Osvaldo Perez, MD” / Hospital Las Higueras – Talcahuano (Vienna transcatheter self-expandable aortic valve SE system pivotal study on the public brief title).
• NCT05871983 — NOT_YET_RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR “Osvaldo Perez, MD” / Hospital Las Higueras – Talcahuano (Munich transcatheter mitral valve safety and effectiveness).
• Affiliation on this page: Hospital Las Higueras – Talcahuano from the public NCT rows above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Osvaldo Perez, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows at Hospital Las Higueras – Talcahuano spanning the Vienna aortic and Munich mitral programs. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Osvaldo Perez, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT04861805 or NCT05871983?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Osvaldo Perez, MD?

ClinicalTrials.gov cites CONTACT and PRINCIPAL_INVESTIGATOR roles at Hospital Las Higueras – Talcahuano on NCT04861805 and NCT05871983, plus OverallOfficial PRINCIPAL_INVESTIGATOR on NCT04861805.

Is this the same page as Hospital Las Higueras Talcahuano?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Las Higueras Talcahuano and this page Osvaldo Perez, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Hospital Las Higueras Talcahuano.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study records NCT04861805 and NCT05871983 (OverallOfficial and/or location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or affiliations beyond the public NCT strings cited here.

If you searched Christian Dauvergne MD first-in-human, Christian Dauvergne Chile clinical trial, Dr Dauvergne Torax Santiago CRO, Vienna TAVR Chile PI, Munich TMVR Chile investigator, or “go direct Christian Dauvergne, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / interventional cardiology device investigation (transcatheter aortic and mitral programs on the public brief titles). A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP 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 ISP, accredited 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 or OverallOfficial field is not a CRO.

This page answers the Dauvergne search. Matching facility page: Instituto Nacional del Tórax Santiago. Facility roles come from ClinicalTrials.gov only. We do not invent dual affiliations, emails, or phones.

Why the 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: Christian Dauvergne, MD (ClinicalTrials.gov also lists Christian Dauvergne without the MD suffix on one CONTACT row).
• NCT04861805 — RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR, and OverallOfficial PRINCIPAL_INVESTIGATOR “Christian Dauvergne, MD” / Hospital Del Torax De Santiago (Vienna transcatheter self-expandable aortic valve SE system pivotal study on the public brief title).
• NCT05871983 — NOT_YET_RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR “Christian Dauvergne, MD” / Hospital Del Torax De Santiago (Munich transcatheter mitral valve safety and effectiveness).
• Affiliation on this page: Hospital Del Torax De Santiago from the public NCT rows above.

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

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

What a named PI or 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:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named investigator is not that 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 name on ClinicalTrials.gov is how you find a person. 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 PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

Christian Dauvergne, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows at Hospital Del Torax De Santiago spanning the Vienna aortic and Munich mitral programs. That is evidence of a person on a Chile campus, not a punchline. Hire the operator. Activate a 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 Christian Dauvergne, MD directly for a device FIH?

You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing 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 NCT04861805 or NCT05871983?

No. We cite the public OverallOfficial and/or location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

What roles does ClinicalTrials.gov show for Christian Dauvergne, MD?

ClinicalTrials.gov cites CONTACT and PRINCIPAL_INVESTIGATOR roles at Hospital Del Torax De Santiago on NCT04861805 and NCT05871983, plus OverallOfficial PRINCIPAL_INVESTIGATOR on NCT04861805.

Is this the same page as Instituto Nacional del Tórax Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Instituto Nacional del Tórax Santiago and this page Christian Dauvergne, MD.

Next step

If the search that brought you here was this name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Instituto Nacional del Tórax 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 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 INDISA Santiago as a bioaccess® client.

If you searched Clínica INDISA Santiago first-in-human, Clinica Indisa clinical trial, INDISA Chile CRO, INDISA Clínica da Familia CRO, or “go direct Clínica INDISA Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Clínica INDISA / Clinica Indisa / INDISA in Santiago, Chile, is a real named private clinic-campus string on ClinicalTrials.gov (aliases include INDISA Clínica da Familia, INDISA, Clinica Indisa, Clínica INDISA, Clínica Indisa). 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 INDISA campus. It is DISTINCT from Clínica Colonial Santiago, Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, and Hospital FACH Santiago. Sharing Santiago metro — and even sharing Levita NCT rows with sibling campuses — is not a license to collapse them. Clínica INDISA is not Clínica Colonial. Clínica INDISA is not Clínica Alemana. Clínica INDISA is not Clínica Las Condes. Clínica INDISA is not Clínica MEDS. Clínica INDISA is not Hospital FACH.

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. We do not invent DEVICE n by unioning all aliases without disclosure.

• INDISA Clínica da Familia (Santiago, Chile) — strongest feasibility anchor: NCT01578642 (Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter…; COMPLETED).
• INDISA (Santiago, Chile) — DEVICE initial clinical evaluation: NCT01927562 (Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes; COMPLETED).
• Clinica Indisa (Santiago, Chile) — modern device cluster: NCT05353777 (Clinical Evaluation of the Levita Robotic Platform; COMPLETED). Shared with FACH / Tisné / San Borja — do not claim as INDISA-only.
• Clínica INDISA (Santiago, Chile) — NCT07017517 (NLRP3 Inflammasome and Physical Therapy…; RECRUITING; DEVICE + BEHAVIORAL). Not a FIH title. Do not treat BEHAVIORAL-only framing as device FIH evidence.

List aliases separately: INDISA Clínica da Familia, INDISA, Clinica Indisa, Clínica INDISA, Clínica Indisa. Strongest FIH/feasibility anchor remains NCT01578642. Modern device cluster includes NCT05353777 (Levita).

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 clinic 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 INDISA Santiago first-in-human finds feasibility and Levita DEVICE rows without finding ISP. A named clinic campus is still a site. An NCT location row is not a CRO. A private-clinic 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 INDISA is not a Clínica Colonial file, not a Clínica Alemana file, not a Clínica Las Condes file, not a Clínica MEDS file, and not a Hospital FACH 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 INDISA Santiago is a serious named Chilean private campus on the public registry — metabolic endoscopy feasibility (NCT01578642) and Levita DEVICE rows are real facility evidence, not a punchline. We do not invent DEVICE n by silently combining aliases. Do not treat NCT07017517 as a FIH title. 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 INDISA 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, Clínica Las Condes, Clínica MEDS, or Hospital FACH?

No. Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, and Hospital FACH Santiago are distinct Santiago campuses. This page is Clínica INDISA / Clinica Indisa / INDISA only.

Did bioaccess® run NCT01578642, NCT01927562, NCT05353777, or NCT07017517?

No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies. NCT05353777 also names other Chile sites; do not treat it as INDISA-only. NCT07017517 is DEVICE + BEHAVIORAL and is not cited here as a FIH title.

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 siblings (do not merge): Clínica Colonial Santiago, Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, Hospital FACH 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 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 del Trabajador Santiago as a bioaccess® client.

If you searched Hospital del Trabajador Santiago first-in-human, Hospital del Trabajador de Santiago clinical trial, Asociación Chilena de Seguridad hospital CRO, or “go direct Hospital del Trabajador Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital del Trabajador in Santiago, Chile, is a real named trauma/occupational hospital-campus string on ClinicalTrials.gov (aliases include Hospital del Trabajador, Hospital del Trabajador de Santiago, Hospital del Trabajador de la Asociación Chilena de Seguridad). 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 del Trabajador campus. It is DISTINCT from Clínica Colonial Santiago, Clínica Alemana de Santiago, Clínica Las Condes Santiago, Clínica MEDS La Dehesa Santiago, Hospital FACH Santiago, and Clínica INDISA Santiago. Sharing Santiago metro is not a license to collapse them.

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

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

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026. DEVICE FIH evidence for this campus is thin — one older feasibility row. Other Chile rows for this campus are mostly non-DEVICE (behavioral, drug, biologic, diagnostic). We do not inflate DEVICE FIH volume.

• Hospital del Trabajador (Santiago, Chile) — sole DEVICE / feasibility title cited here: NCT00823251 (IlluminOss Hand Fracture International Clinical Feasibility Study; COMPLETED).

Aliases seen on the registry family: Hospital del Trabajador, Hospital del Trabajador de Santiago, Hospital del Trabajador de la Asociación Chilena de Seguridad. List separately. We do not invent a deep FIH/EFS portfolio from non-DEVICE rows.

That single NCT ID is facility evidence, not a count of first-in-human device programs bioaccess® ran. It is how a sponsor searching the hospital name lands on a campus without landing on an operator.

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

That is the leak: a founder searching Hospital del Trabajador Santiago first-in-human finds an IlluminOss clinical-feasibility DEVICE row without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO. A trauma-hospital brand story is still not a CRO — and a thin DEVICE portfolio is not a deep FIH pipeline.

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 del Trabajador is not a Clínica Colonial file, not a Hospital FACH file, and not a Clínica INDISA 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 del Trabajador Santiago is a serious named Chilean trauma/occupational campus on the public registry — IlluminOss clinical-feasibility DEVICE evidence under Hospital del Trabajador is real, not a punchline. The portfolio is thin. Do not inflate DEVICE FIH volume from non-DEVICE rows. 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 timing in Panama and Colombia follows 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 del Trabajador 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 ID 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 study.

Is this the same page as Hospital FACH or Clínica INDISA?

No. Hospital FACH Santiago and Clínica INDISA Santiago are distinct Santiago campuses. This page is Hospital del Trabajador / Hospital del Trabajador de Santiago / Asociación Chilena de Seguridad hospital only.

Did bioaccess® run NCT00823251?

No. We cite it as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran this study. DEVICE FIH evidence here is thin — one COMPLETED IlluminOss clinical-feasibility row.

Next step

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

If you searched Hospital FACH Santiago first-in-human, Hospital Fach clinical trial, Hospital FACH Chile CRO, Fuerza Aérea de Chile hospital CRO, or “go direct Hospital FACH Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital FACH / Hospital Fach in Santiago, Chile, is a real named military/institutional hospital-campus string on ClinicalTrials.gov (Fuerza Aérea de Chile hospital family). 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 FACH campus. It is DISTINCT from Clínica Colonial Santiago, Hospital Luis Tisné Santiago, and Clínica INDISA Santiago. Sharing Santiago metro — and even sharing Levita magnetic / robotic-platform NCT rows with sibling campuses — is not a license to collapse them. Hospital FACH is not Clínica Colonial. Hospital FACH is not Hospital Luis Tisné. Hospital FACH is not Clínica INDISA. Overlapping Levita sites exist elsewhere in Chile; we do not claim FACH-only for shared studies.

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. We do not pad DEVICE n with non-DEVICE Hospital Fuerza Aérea de Chile rows.

• Hospital Fach (Santiago, Chile) — NCT string as published: DEVICE feasibility row NCT05695989 (Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System…; COMPLETED).
• Hospital FACH (Santiago, Chile) — NCT string as published: DEVICE evaluation row NCT05353777 (Clinical Evaluation of the Levita Robotic Platform; COMPLETED). Title lacks an explicit FIH token; cite as a DEVICE facility string.

List Hospital Fach and Hospital FACH separately. Same campus family (Fuerza Aérea de Chile hospital). We do not invent a combined DEVICE n. Sibling Chile sites on overlapping Levita rows include Colonial, Tisné, San Borja, and INDISA — do not claim those NCT IDs as FACH-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 Hospital FACH Santiago first-in-human finds Levita magnetic / robotic-platform DEVICE rows without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO. A military-hospital brand story is still not a CRO.

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

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

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

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

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

• 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 FACH is not a Clínica Colonial file, not a Hospital Luis Tisné file, and not a Clínica INDISA 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 FACH Santiago is a serious named Chilean military/institutional campus on the public registry — Levita magnetic / robotic-platform DEVICE rows under Hospital Fach and Hospital FACH are real facility evidence, not a punchline. Do not pad DEVICE volume with non-DEVICE Fuerza Aérea rows. We do not invent “Chile’s top FIH hospital” 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. 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 FACH 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 Clínica Colonial Santiago or Clínica INDISA Santiago?

No. Clínica Colonial Santiago and Clínica INDISA Santiago are distinct Santiago campuses. This page is Hospital FACH / Hospital Fach only (Fuerza Aérea de Chile hospital family).

Did bioaccess® run NCT05695989 or NCT05353777?

No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies. NCT05353777 also names other Chile sites (including Clínica Indisa); do not treat it as FACH-only.

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 siblings (do not merge): Clínica Colonial Santiago, Hospital Luis Tisné Santiago, Clínica INDISA Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®