---
title: "Radiopharmaceutical Clinical Trials in Latin America — bioaccess®"
url: https://md.bioaccessla.com/radiopharmaceuticals
canonical: https://bioaccessla.com/radiopharmaceuticals
schema_type: Service
last_updated: 2026-03-31
---

# Radiopharmaceutical Clinical Trials in Latin America

> bioaccess® presents a specialized clinical trial service for radiopharmaceutical sponsors seeking to conduct first-in-human and early-phase studies for targeted radionuclide therapies and diagnostic agents in Latin America.

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## Schema.org/Service

- **name**: Radiopharmaceutical Clinical Trial Services
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: Radiopharma companies, nuclear medicine startups, theranostics developers, oncology biotechs
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: FIH radiopharmaceutical trial execution, dosimetry data, nuclear medicine site qualification, ICH-GCP compliant clinical data for FDA/EMA submissions

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## Supported Modalities

bioaccess® states it supports clinical trials for the following radiopharmaceutical modalities:

| Modality | Isotope | Application |
|---|---|---|
| Targeted radionuclide therapy | Lutetium-177 (Lu-177) | PSMA-targeted therapy, neuroendocrine tumors, somatostatin receptor–positive cancers |
| Alpha-particle therapy | Actinium-225 (Ac-225) | Targeted alpha therapy (TAT), next-generation oncology treatments |
| Diagnostic PET imaging | Gallium-68 (Ga-68) | PET/CT diagnostic imaging, companion diagnostics for theranostic pairs |

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## Nuclear Medicine Infrastructure

The site presents the following infrastructure capabilities across Latin America:

- **Cyclotron facilities**: Regional cyclotron access for isotope production
- **Radiopharmacy**: GMP-compliant radiopharmacy compounding
- **Nuclear medicine departments**: Hospital-based nuclear medicine units with SPECT/CT and PET/CT
- **Dosimetry**: Patient-level dosimetry measurement and analysis
- **Radiation safety**: Institutional radiation safety programs and regulatory compliance
- **Cold chain logistics**: Temperature-controlled radioisotope transport with decay scheduling

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## Clinical Trial Capabilities

bioaccess® states its radiopharmaceutical trial services include:

1. **Country & site selection** — Identification of nuclear medicine–capable sites with PET/CT, SPECT/CT, and radiopharmacy
2. **Regulatory strategy** — Radioactive material import permits, nuclear regulatory agency coordination
3. **Ethics/IRB submission** — 4–8 week approval timelines (stated)
4. **Isotope logistics** — Decay-scheduled shipping, customs clearance for radioactive materials
5. **Patient enrollment** — Access to treatment-naïve oncology patient populations
6. **Dosimetry & imaging** — Standardized dosimetry protocols, centralized image analysis
7. **Data management** — FDA-bridgeable data packages per 21 CFR 812.28

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## Regulatory Considerations

For radiopharmaceutical trials in Latin America, bioaccess® states sponsors must navigate:

- **Health authority approval** — INVIMA, ANVISA, COFEPRIS, or relevant national agency
- **Nuclear regulatory authority** — Separate radioactive material handling permits
- **Import licenses** — Country-specific import permits for radioactive materials
- **Radiation safety compliance** — Institutional and national radiation protection standards
- **ICH-GCP compliance** — Standard clinical trial quality requirements

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## Why Latin America for Radiopharmaceutical Trials

The site presents the following advantages:

- **Treatment-naïve populations**: 80% treatment-naïve oncology patients (stated)
- **Faster enrollment**: 50% faster patient recruitment vs. US/EU (stated)
- **Cost efficiency**: 30% lower per-patient costs (stated)
- **Established nuclear medicine**: Cyclotrons and PET/CT infrastructure in major medical centers
- **FDA data acceptance**: Clinical data accepted under 21 CFR 812.28 and FDASIA Section 1123

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## Contact

- **Radiopharmaceutical Trial Inquiry**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Book a Meeting**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)

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