Managing regulated IP in Japan
The sponsor intended to conduct a program of six studies testing a very expensive radioactive, oncology treatment in Japan, with the first study being a pivotal one for awarding the remaining five studies. Aside from the special shipping and storage conditions required for the IP, which cost over $10,000 per dose, the trial had to comply with Japanese regulations on the handling of radioactive material. The regulations impose a limit on the amount of material sites can carry and require that only depots with special licenses can store and ship these products.
Could Almac design its IRT system, IXRS®3, to accommodate different sourcing for the radioactive IP and the standard chemotherapy drugs used as comparators? How could this be accomplished without tipping off site staff as to which treatment arm a subject belonged? What would be required to track and reconcile return shipments?
Find out in our latest case study.
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