The clinical supply chain is unique to itself, distributing to hundreds of study sites, often world-wide. The rapid growth of biological based pharmaceuticals is apparent in clinical trials today, creating even greater demands on clinical logistics practitioners handling biological specimens such as DNA and RNA. Cold Chain IQ provides industry insights exploring how the efficient supply of clinical materials and IMPs is the lynchpin to ensuring patients are dosed on time and clinical trials run efficiently.
A key step in developing a new drug is the transition from the laboratory to the human subject in a Phase I clinical trial, where the new compound is given to humans for the first time. A Phase I trial is the gateway between scientific research and clinical medicine. Generally, in-human Phase I studies are conducted in healthy male patients or he Full Article »