CASE STUDY : INVESTIGATOR INITIATED STUDIES (IIS) An investigator initiated study (IIS) involves the use of a product in a clinical trial initiated by an investigator, rather than a pharmaceutical company . Thus, an IIS is not the same as a regular phase I, II, or III clinical trial. The investigator is responsible for the packaging and labeling, release, and distribution of the investigational medicinal product (IMP). The pharmaceutical company will usually support the IIS by providing its drug product at no cost. Competent national authorities require independence between the pharmaceutical company and the investigator in an IIS, but ensuring that independence can be challenging. This case study outlines how Clinical Supplies Management (CSM) provided smart and simple solution

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