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📖 Description
In many ways, the ICH Good Clinical Practice manual for investigational medicinal products is very similar to ISO 14155:2011 for medical device trials. It's an important document packed with vital information every investigator should know in order to perform biopharmaceutical and medical device trials compliant with international standards and best practices.
"The Little Advisor ICH GCP for Investigational Products Trials" condenses all the key concepts in the ICH Good Clinical Practice manual into a practical, manageable size for biopharmaceutical and medical device trials. With full citations back to the original ICH GCP document in case additional detail is required, clinical investigators get easy-to-find, practical information and good advice.