Combining multiple studies for clinical trial analysis requires the generation of Integrated Summaries for a regulatory submission, this isn’t always straight forward due to the unique nature of each submission and understanding the best way to plan your ISS/ISE can be difficult.
This guide outlines the issues that can arise in the planning of an Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
Downloading this whitepaper enables you to:
- Plan the analyses and summaries of ISS/ISE documents
- Plan for data submissions
- Create report of the study
- Better manage timelines
- Minimize workloads
- Reduce any issues at the production stage