概览

With the pharmaceutical development process becoming increasingly competitive, complex, and global, it is necessary for clinical research professionals to clearly understand their roles and the roles of others they interact with. This knowledge helps them facilitate a pharmaceutical development process that is both timely and completed within budget.
Through interactive lectures and exercises, this online course will provide clinical research professionals with the knowledge and skill set needed to improve the pharmaceutical development process. Topics to be addressed include product development strategy, clinical trial management and development, project management, and quality concepts.
Course Level: Beginner

内容纲要

Product development plan

Target product profile
Multinational studies
Industry challenges

Clinical trial processes

Protocol development
Data collection methods
Informed consent challenges
Study reports
New drug applications (NDA)/common technical document (CTD)

Quality concepts

Site management
Auditing

谁应该参加？

Clinical research professionals working in these areas:

Clinical operations
Regulatory affairs
Data management
Project management
Medical writing

Site personnel
Medical monitors

学习目标

Participants who complete this course should be able to:

Discuss current practices and challenges in clinical trial management
Discuss the product development process and identify some challenges facing the industry in today’s environment
Discuss ethical principles of clinical research and applicable regulations
Outline the process for protocol development, case report form design, and preparation of integrated study reports
Demonstrate knowledge about concepts and functions associated with ensuring overall quality of studies
Apply clinical research planning principles

Proven Strategies for Creating an Effective Clinical Research Program

概览

内容纲要

谁应该参加？

学习目标

获得信息并保持参与