Clinical study protocols serve as the foundation for a single study, but also for an entire clinical program. Protocols need to be strategic, but they also need to be clear, user-friendly, and set to construct a study that will meet a company’s overall objectives for their drug.
This webinar will focus on how to create a solid protocol in line with ICH E6 guidelines. Participants will gain an understanding of how to interpret the guidelines through real-life practical experiences from a seasoned medical writer.
Topics of discussion will include the current standards and guidelines outlined by ICH E6, project planning, writing and review processes, strategic meetings, and project management.