Case Study: Pfizer achieves streamlined FDA reporting and powerful data analysis with TIBCO Software (StatServer/S-PLUS)

Pfizer Deploys Intranet-Based Statserver Technology To Improve FDA Reporting

Pfizer’s Pharmaceutical Delivery System (PDS) team needed to improve the accuracy, consistency and efficiency of statistical analyses and FDA submissions. Historically researchers prepared their own lengthy, nonstandard reports—often 30–40 pages of separate graphs—making review slow and inconsistent. Pfizer sought a solution that combined powerful analytics, high-quality graphics, browser access and Microsoft Office integration.

Using an intranet-based StatServer deployment of S-PLUS, Pfizer built a web application that lets researchers upload data (including Excel), run advanced analyses (e.g., ANCOVA with confidence bands) and produce conditioned multi-panel (Trellis) plots for FDA reports. The result was standardized, concise, easy-to-read reports with richer visualizations, faster reviewer understanding and improved workflow efficiency—helping expedite regulatory decisions and streamline time to market.

Pfizer

John Twist

Section Director, PDS Planning and Statistics