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May 01, 2026
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Catalog 2015-2016 [ARCHIVED CATALOG]
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PIM 6025 - Clinical Research Management Process: From Lab to Human Patient(3 units)
This course helps aspiring executives in pharmaceutical firms develop a comprehensive understanding of what happens to a drug once it leaves and enters clinical trials. Students will become familiar with what data doctors, clinicians, and the FDA are looking for during the Clinical Research Management (CRM) process. This type of data can be instrumental for future firm strategic funding and marketing decisions that need to be made by the firm. Specific topics to be covered are clinical research ethics, research budget vs clinical trial budget considerations, strategic partnerships with companies to conduct clinical trials, detailed descriptions of Phase 1 - Phase IV clinical trial process, patient extension strategies, liability management strategies, examination of the drug approval processes in other countries.
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