Implementing APT© for CDISC Data

A mid-sized Biotech client acquired PharmaStat’s APT© Software Library in preparation for an FDA filing. The submission consisted of two Phase III studies and a Phase II study — which were included as individual study reports — and an integrated efficacy analysis. An outside vendor conducted integrated safety analysis and early-phase study reports. Several specialized... Read more »

Setting Up a Statistical Computing Environment

A mid-sized Biotech company contacted PharmaStat to redesign their Statistical Computing Environment (SCE) in preparation for their first NDA. They started by licensing PharmaStat’s APT© Software Library to improve productivity. We developed use cases to help Biometrics staff visualize the new SCE. The use cases would become requirements for vendor selection, workforce development, software production,... Read more »