Tag: IOR/EOR

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How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to […]

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Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others.  Japan’s clinical trial regulations differ from […]

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