Radiopharmaceutical Clinical Trials — U.S. & Latin America — bioaccess®

bioaccess® runs radiopharmaceutical and theranostics clinical trials with U.S. regulatory anchoring (FDA Pre-Sub, IND) plus Latin American execution. Dedicated nuclear medicine infrastructure and the most experienced radiopharmaceutical investigators across our Latin American site network.

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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