[Free White Paper]
A guide on how to prepare your ISS/ISE for regulatory submissions
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:
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