If you searched Dr. Carlos Rojas Bradford Hill, Carlos Rojas first-in-human Chile, or Sona THT principal investigator, you found a real investigator in the public record. Dr. Carlos Rojas is named by Sona Nanotech as the principal investigator of its first-in-human Targeted Hyperthermia Therapy study and as executive director of Bradford Hill in Santiago, Chile. A principal investigator is not the CRO.
bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.
What the public record says
- Sona Nanotech, 16 June 2025: clinical trial agreement with Bradford Hill Investigación Clínica, Santiago, for an early feasibility study of THT in up to ten advanced melanoma patients; Dr. Carlos Rojas named principal investigator and Bradford Hill executive director.
- Sona Nanotech, 20 October 2025: study completion; Dr. Rojas, quoted as executive director of the Bradford Hill Clinical Cancer Research Center, described rapid responses in patients who had exhausted standard immunotherapy.
- ClinicalTrials.gov NCT06894407: industry sponsor Sona Nanotech Inc, DEVICE_FEASIBILITY, enrollment 10, single location Bradford Hill, Santiago, Chile; no CRO or collaborator listed; record updated 2 October 2026 to COMPLETED.
The facility-level page is here: Bradford Hill, Santiago: the site is not the CRO.
PI versus CRO
| Workstream | Principal investigator | First-in-Human CRO |
|---|---|---|
| Clinical judgment and cases | Yes | Supports with protocol training and monitoring |
| ISP file and amendments | Signs what the site must sign | Prepares, submits, and answers deficiencies |
| Device import | No | Importer of record for the investigational device |
| ISO 14155 monitoring and TMF | Keeps source documents | Monitors, reconciles, and closes out |
| FDA 21 CFR 812.28 | Provides site data | Builds the foreign-data narrative for the U.S. submission |
FAQ
Did bioaccess® work on Dr. Rojas’s Sona study?
No. This page reports public sources only and claims no role in that study.
Does bioaccess® only work in Chile?
No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.
Sources: Sona Nanotech press releases of 16 June 2025 and 20 October 2025; ClinicalTrials.gov NCT06894407. Public sources only.
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