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.
