Comprehensive ISS and ISE documents that synthesize your clinical program
Integrated summaries bring together data from across your clinical development program to present a comprehensive picture of your product's efficacy and safety. These documents are essential components of NDA and BLA submissions, providing FDA reviewers with the pooled analyses and cross-study comparisons they need to evaluate your product.
The ISS presents pooled safety data across your clinical program including extent of exposure, adverse events, serious adverse events, laboratory abnormalities, and special populations analyses.
The ISE presents pooled efficacy data supporting your proposed indication including primary and secondary endpoints, subgroup analyses, dose-response, and persistence of effect.
We work with your biostatistics team to review the integrated analysis plan and understand pooling strategies.
We create detailed document shells aligned with FDA expectations and your submission strategy.
We incorporate pooled analyses, cross-study comparisons, and subgroup analyses into clear narratives.
We ensure consistency between ISS, ISE, Module 2.7 summaries, and individual CSRs.
Integrated summary development typically begins 6-9 months before NDA submission, after pivotal study topline results are available. Planning can start earlier to align pooling strategies.
We work closely with your biostatistics team throughout development. We participate in analysis plan discussions, review draft outputs, and iterate on presentation approaches.
Yes. We can update existing integrated summaries to incorporate new studies or extended follow-up data for supplemental NDAs, new indication applications, or post-marketing commitments.
Contact ESW Communications to discuss your NDA or BLA requirements.
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