About this Course

Clinical trials involve a large number of tasks and people who are responsible for different parts of the overall study. The relationships among these parties require understanding and careful management to produce a successful study. Clinical trials have a business dimension that includes principles of project management, planning, analysis, contingency and follow-up.

Topics involving the management of clinical trials include:

• Project management, budgets and timelines
• Managing relationships among clinical trials constituencies (CRCs, CRAs, investigators, subjects, staff, IRBs, sponsors, etc.)
• Management of people at work
• Public relations and current topics

Topics involving the business of clinical trials include:

• Public speaking and basic business skills such as personnel management and control of meetings
• Overall investigational plan, including budgets and timelines
• Quantifying business decisions and basic financial analysis tools
• Site negotiations in single and multisite trials
• Outsourcing and Contract Research Organizations (CROs)
• The art of negotiations
• Developing strategic partnerships