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Overview

This training course provides a comprehensive overview of the essential elements of clinical trial management and the overall drug development process, using real case studies, practical examples and group exercises. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study.

What you will learn

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

 

Who should attend?

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 Professionals.