Integrated Summaries of Safety and Efficacy

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