This paper looks at how a Medical Writer should contribute to the production of a quality ISS/ISE. It follows a previous white paper on the role of Statisticians and Programmers in the production of integrated summaries.
The paper will examine:
- The benefits of Successful Integration
- The Relationship between the ISS/ISE and Module 2 of the CTD
- Starting to Write an ISS/ISE
- Review of the ISS/ISE