Author: Julio Martinez-Clark

Names and roles cited from ClinicalTrials.gov study record NCT07431723 (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 James Hamilton MD first-in-human, James Hamilton Chile clinical trial, Dr Hamilton MEDS La Dehesa CRO, GT Metabolic magnet anastomosis Chile PI, Clínica MEDS investigator, or “go direct James Hamilton, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is digestive / metabolic anastomosis device investigation (GT Metabolic magnet compression anastomosis 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 Hamilton search. Matching facility page: Clínica MEDS La Dehesa 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: James Hamilton, MD.
• NCT07431723 — RECRUITING DEVICE row; location PRINCIPAL_INVESTIGATOR “James Hamilton, MD” / Clinica MEDS La Dehesa SpA (creation of compression anastomosis using the GT Metabolic magnet system on the public brief title).
• Affiliation on this page: Clinica MEDS La Dehesa SpA 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

James Hamilton, MD, is a named public NCT principal investigator on a serious DEVICE row at Clinica MEDS La Dehesa SpA for the GT Metabolic magnet anastomosis 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 James Hamilton, 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 NCT07431723?

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 James Hamilton, MD?

ClinicalTrials.gov cites location PRINCIPAL_INVESTIGATOR “James Hamilton, MD” / Clinica MEDS La Dehesa SpA on NCT07431723.

Is this the same page as Clínica MEDS La Dehesa Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica MEDS La Dehesa Santiago and this page James Hamilton, 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 MEDS La Dehesa Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT05353777 (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 Ignacio Robles MD first-in-human, Ignacio Robles Chile clinical trial, Dr Robles Hospital FACH CRO, Levita robotic platform Chile PI, FACH Santiago investigator, or “go direct Ignacio Robles, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical / robotic-platform device investigation (Levita robotic platform clinical evaluation 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 Robles search. Matching facility page: Hospital FACH 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: Ignacio Robles, MD.
• NCT05353777 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Ignacio Robles, MD” / Hospital FACH (clinical evaluation of the Levita robotic platform on the public brief title).
• Affiliation on this page: Hospital FACH 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

Ignacio Robles, MD, is a named public NCT principal investigator on a serious DEVICE row at Hospital FACH for the Levita robotic platform 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 Ignacio Robles, 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 NCT05353777?

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 Ignacio Robles, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Ignacio Robles, MD” / Hospital FACH on NCT05353777.

Is this the same page as Hospital FACH Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital FACH Santiago and this page Ignacio Robles, 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 FACH Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study records NCT06915337 and NCT06915818 (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 Pablo Marin MD first-in-human, Pablo Marin Chile clinical trial, Dr Marin Colonial Chile CRO, magnet anastomosis Colonial PI, Flexagon OTOLoc Chile investigator, or “go direct Pablo Marin, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is digestive / surgical anastomosis device investigation (magnet gastric anastomosis and Flexagon Plus OTOLoc colon anastomosis 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 Marin 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: Pablo Marin, MD.
• NCT06915337 — RECRUITING DEVICE row; location CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR “Pablo Marin, MD” / Clinica Colonial Hospital (magnet anastomosis in patients undergoing gastric surgery on the public brief title).
• NCT06915818 — RECRUITING DEVICE row; location CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR “Pablo Marin, MD” / Clinica Colonial Hospital (Flexagon Plus OTOLoc colon anastomosis on the public brief title).
• Affiliation on this page: Clinica Colonial Hospital 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

Pablo Marin, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows at Clinica Colonial Hospital spanning magnet gastric and Flexagon colon anastomosis 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 Pablo Marin, 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 NCT06915337 or NCT06915818?

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 Pablo Marin, MD?

ClinicalTrials.gov cites CONTACT and OverallOfficial PRINCIPAL_INVESTIGATOR roles at Clinica Colonial Hospital on NCT06915337 and NCT06915818.

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 Pablo Marin, 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 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 Martín Valdebenito MD first-in-human, Martin Valdebenito Chile clinical trial, Dr Valdebenito Sotero del Rio CRO, Munich TMVR Chile PI, Sótero del Río investigator, or “go direct Martín Valdebenito, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is structural / interventional cardiology device investigation (Munich transcatheter mitral valve 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 Valdebenito search. Matching facility page: Hospital Dr. Sótero del Río 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: Martín Valdebenito, MD.
• NCT05871983 — NOT_YET_RECRUITING DEVICE row; location CONTACT and PRINCIPAL_INVESTIGATOR “Martín Valdebenito, MD” / Hospital Dr Sotero Del Rio De Santiago (Munich transcatheter mitral valve safety and effectiveness).
• Affiliation on this page: Hospital Dr Sotero Del Rio De Santiago 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

Martín Valdebenito, MD, is a named public NCT principal investigator and site contact on a serious DEVICE row at Hospital Dr Sotero Del Rio De Santiago for the Munich mitral 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 Martín Valdebenito, 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 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 Martín Valdebenito, MD?

ClinicalTrials.gov cites CONTACT and PRINCIPAL_INVESTIGATOR roles at Hospital Dr Sotero Del Rio De Santiago on NCT05871983.

Is this the same page as Hospital Dr. Sótero del Río Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Hospital Dr. Sótero del Río Santiago and this page Martín Valdebenito, 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 Dr. Sótero del Río Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Names and roles cited from ClinicalTrials.gov study record NCT01348828 (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 Renato Mertens MD first-in-human, Renato Mertens Chile clinical trial, Dr Mertens Universidad Catolica CRO, Endologix fenestrated stent graft Chile PI, UC Católica vascular investigator, or “go direct Renato Mertens, MD,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is vascular / endovascular device investigation (Endologix fenestrated stent graft feasibility and safety 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 Mertens 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: Renato Mertens, MD.
• NCT01348828 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Renato Mertens, MD” / Hospital Universidad Catolica (feasibility and safety study of the Endologix fenestrated stent graft system on the public brief title).
• Affiliation on this page: Hospital Universidad Catolica 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

Renato Mertens, MD, is a named public NCT principal investigator on a serious DEVICE feasibility-and-safety row at Hospital Universidad Catolica for the Endologix fenestrated stent graft 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 Renato Mertens, 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 NCT01348828?

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 Renato Mertens, MD?

ClinicalTrials.gov cites OverallOfficial PRINCIPAL_INVESTIGATOR “Renato Mertens, MD” / Hospital Universidad Catolica on NCT01348828.

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 Renato Mertens, 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 NCT07470411 (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 Susana Benitez Seguel first-in-human, Susana Benitez Chile clinical trial, Benitez Seguel Las Condes CRO, MACS surgical Chile PI, Clínica Las Condes investigator, or “go direct Susana Benitez Seguel,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. The public posture visible on those rows is surgical device investigation (MACS safety and feasibility in surgical procedures 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 Benitez search. Matching facility page: Clínica Las Condes 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: Susana Benitez Seguel (as published on ClinicalTrials.gov — we do not invent an MD suffix).
• NCT07470411 — RECRUITING DEVICE row; location PRINCIPAL_INVESTIGATOR “Susana Benitez Seguel” / Clinica Las Condes (safety and feasibility of the MACS in surgical procedures on the public brief title).
• Affiliation on this page: Clinica Las Condes 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

Susana Benitez Seguel is a named public NCT principal investigator on a serious DEVICE safety-and-feasibility row at Clinica Las Condes for the MACS surgical 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 Susana Benitez Seguel 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 NCT07470411?

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 Susana Benitez Seguel?

ClinicalTrials.gov cites location PRINCIPAL_INVESTIGATOR “Susana Benitez Seguel” / Clinica Las Condes on NCT07470411. We do not invent an MD title beyond that public string.

Is this the same page as Clínica Las Condes Santiago?

No. That is the facility page. This is the named PI / site-contact page. These pages are distinct: Clínica Las Condes Santiago and this page Susana Benitez Seguel.

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 Las Condes Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

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®