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Creating a Comprehensive Project Plan essay assignment
Select a therapeutic area (eg cardiovascular, oncology, etc) and create a comprehensive project plan for a drug to be developed in this area
Select a therapeutic area (eg cardiovascular, oncology, etc) and create a comprehensive project plan for a drug to be developed in this area. In this plan, identify the four phases of drug development, the approximate number of patients/subjects to be included in each phase, and the purpose of each phase. Identify the operational steps (what you need to do) in taking the drug through each phase and what training you would provide the sites so that they would know what their responsibilities were as regards GCP’s.
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In your operational plan, include what responsibilities the monitor would have with regard to site management and what responsibilities the study coordinator would have to the patient population. Identify the steps you would take in creating case report forms and a database.
Identify the different types of audits that might occur during your drug development and compare and contrast them. Finally, this is the creative and “fun” part…….Develop branding for your product, complete with marketing strategy, including who is your target audience (AKA patient population), a logo, and hypothetical advertisement.
