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[Free White Paper]

Integrated Summaries of Safety and Efficacy

The Role of the Medical Writer

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

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Integrated Summaries Medical Writing

 

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