Off-Site Shipment System for Unapproved Radiopharmaceuticals in Clinical Trials in Japan
Advancing Radiopharmaceutical Clinical Trials in Japan
Discover how CMIC is helping sponsors navigate the regulatory and operational complexities of conducting clinical trials involving unapproved radiopharmaceuticals in Japan.
Key Highlights:
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Proven Clinical Trial Experience: Supported four clinical trials across two sponsors and four medical institutions, successfully completing 174 inter-site radiopharmaceutical transports.
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Navigating Japan’s Regulatory Requirements: Established a compliant transportation framework addressing Japan’s Radioisotope (RI) Act and clinical trial requirements.
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Streamlined Study Start-Up: Developed a standardized implementation framework supporting clinical trial preparation in approximately six months.
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Coordinated Clinical Trial Operations: Established processes connecting manufacturing facilities, imaging sites, transportation vendors, sponsors, and CROs.
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Supporting Radiopharmaceutical Innovation: Demonstrated a practical, sustainable model to help sponsors plan and execute radiopharmaceutical clinical trials in Japan.
Download the full report to explore CMIC’s proven approach to radiopharmaceutical clinical trial operations in Japan.
