Project Management for Phase 1 & 2 Clinical Trials

This blended learning course includes online and classroom curriculum. The online portion is self-paced and represents an introductory prerequisite to the classroom session. Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react, and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.
The classroom portion of the course will discuss the challenges associated with clinical trials run outside the United States and will review key differences, common pitfalls, and cultural challenges. The classroom instruction will include a key project management risks during trials such slow enrollment, high screen failures, or issues with data quality. The classroom portion is interactive, uses case example and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.