Radiopharmaceutical Clinical Trials — the Americas — bioaccess®

The first-in-human CRO for the Americas. bioaccess® supports radiopharmaceutical and theranostics first-in-human and early feasibility trials (Lu-177, Ac-225, Ga-68), with FDA Pre-Sub and IND strategy from Miami and execution across the Americas.

Modalities

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

What a radiopharma trial needs

Radiopharmaceutical trials need nuclear-medicine-capable sites with radiation licensing, hot-lab/radiopharmacy handling, dosimetry and PET/SPECT imaging, and isotope logistics timed to short half-lives. bioaccess® activates the right investigators, sites and regulatory resources on demand for each program.

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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