The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members, and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk.
This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study from protocol to final report.
- Drug Development Process
- Feasibility Assessment
- Study Planning Tools
- Regulatory Framework
- Quality Management System
- Essentials of Site Management
- Resource Management
- Investigational Product Handling
- Risk Management
- Safety Reporting
- Study Evaluation and Reporting