This course will particularly benefit those newly appointed to a clinical study management position, e.g. monitors and clinical research professionals with some basic experience in the field of clinical research, who need a broader understanding of the principles of clinical study management. The course will also benefit those who interact with clinical trial managers (such as IT, Finance, PV, QA and CTAs) as well as those in an academic research setting who interface with industry.
Clinical Research Professionals including CRAs, IT staff, Data Managers, Clinical Study Managers, Quality Management.

This course will provide a deep insight into strategies and tools to prepare launch and manage a clinical trial from protocol to final report.

At the conclusion of this course, participants will have a clear understanding about:

• The clinical research phases and basic concepts of study design
• Clinical Trial start-up incl. Regulatory framework, Study planning, Budgeting
• Clinical Trial Conduct incl. Vendor management, Performance metrics, Communication plans, Risk management, Quality Management, Safety reporting requirements
• General data management, statistical evaluation process and requirements for final study report preparation