Case study

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.

View Resource
Almac Logo

Almac Clinical Technologies

Almac Clinical Technologies is here to help the biopharmaceutical industry bring new therapies to those in need by empowering clinical trial sponsors to proactively manage sites, patients, and clinical trial supplies through our industry-leading Interactive Response Technology (IRT) and expert consultancy.

Almac Clinical Technologies is uniquely positioned to unlock new efficiencies in the clinical supply chain and to help achieve greater predictability in your projects and programs.

Our professionals are dedicated to delivering high-quality Interactive Response Technology (IRT) solutions, dependable professional services, and reliable customer service. Our expertise, energy, and commitment have earned us a reputation as a trusted ally in the drug development process.

Learn More

Download here instantly

This website uses cookies. By continuing to browse the site, you are agreeing to our use of cookies