Integrating efficacy and safety data across multiple studies is never simple—especially when patient-reported outcomes, complex study designs, and multiple safety populations are involved.
In this case study, see how Phastar partnered with a global sponsor to deliver both an Integrated Summary of Efficacy (ISE) and an Integrated Summary of Safety (ISS) for a treatment targeting vasomotor symptoms (VMS) associated with menopause.
You’ll discover how Phastar:
- Anticipated integration needs with consistent programming across pivotal studies
- Applied robust statistical methods and sensitivity analyses to strengthen results
- Defined five clear, population-specific safety groups for transparent reporting
- Maintained regulatory alignment with traceable dictionary up-versioning
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