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ISS: Streamlining Complex Data Pooling
Stream of blue particles forming a data network

Delivering a Complex Integrated Summary of Effectiveness: Efficient Pooling and Advanced Analysis Across Four Multiple Sclerosis Spasticity Studies 

1 minute read

Published: November 17th, 2025

A sponsor needed to pool data from four MS spasticity studies—one still ongoing with another vendor—while adapting mid-project to a new SDTM-level pooling strategy. Unique baseline derivations, advanced analyses, and regulatory expectations added further complexity.

Solution
Phastar introduced a modular workflow separating statistical analysis from TFL production. This streamlined process reduced run times, improved efficiency, and ensured consistency across all studies.

Outcome
Over 200 high-quality TFLs
Submission-ready Clinical Review Template (CRT)
Robust evaluation of treatment effects across time and subgroups

Download the case study to see how Phastar delivered a complex ISE on time and to regulatory standards.

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