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 intercepts the Valdebenito search. Matching facility intercept (do not merge): Hospital Dr. Sótero del Río Santiago. Cite facility roles from ClinicalTrials.gov only. 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 intercept: 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-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.
Do not smear 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. Cite the name. Hire the operator. Activate a campus only if it fits.
Colombia is still on the map
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. 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 intercept as Hospital Dr. Sótero del Río Santiago?
No. That is the facility intercept. This page is the named PI / site-contact intercept. Keep the pages distinct: hospital-dr-sotero-del-rio-santiago-fih and this slug martin-valdebenito-chile-fih.
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®
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