Novel drug and trial design generate unique clinical supply management challenges. OrthoTrophix began a two-part, phase 2 clinical trial in February 2014. The first part tested the drug’s safety and efficacy in 27 patients with mild to moderateRead More
March 27, 2018
Change Your Perspective
EU Good Distribution Practice (GDP) require that sponsor companies have a thorough understanding of how clinical supplies are handled and temperature monitored.
For example, do your clinical sites know whatRead More
Clinical studies of breakthrough therapy-designated drugs present multiple clinical supply management issues, such as the need to adapt to rolling FDA recommendations regarding clinical study design, endpoints, and study size, even once the studyRead More