Radiopharmaceutical Clinical Trials in Latin America — bioaccess®

bioaccess® states it is the only CRO in Latin America with dedicated infrastructure and expertise for radiopharmaceutical and theranostics clinical trials.

Modalities

• Lutetium-177 (Lu-177) — therapeutic radiopharmaceuticals
• Actinium-225 (Ac-225) — targeted alpha therapy
• Gallium-68 (Ga-68) — diagnostic PET imaging

Infrastructure

bioaccess® states it has access to nuclear medicine departments, PET/CT scanners, cyclotrons, and radiopharmacy facilities across its Latin American site network. The company states its sites have experience handling radioactive materials and complying with IAEA guidelines.

Services

• Radiopharmaceutical FIH trial design and execution
• Nuclear medicine site selection and qualification
• Radioactive material logistics and import permits
• Dosimetry and imaging protocol standardization
• Regulatory submissions for radiopharmaceutical trials
• FDA-bridgeable data generation

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