A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
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This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
In this article we share our experience of a recent integration using the ADaM standards in order to ensure the safety and effectiveness of interventions.
Following on from the previous blog posts on Integrated Summaries we can explore the use of CDISC SDTM for Cost and Quality efficient ISS/ISE studies