Pharmaceutical Users of Software Exchange (PhUSE) - a quick overview

• Activity Number: 100
• Type: Invited
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Michael Carniello*+
• Companies: Takeda Global Research & Development Center, Inc.
• Keywords: PhUSE ; open source ; clinical trials

Abstract

The FDA/PhUSE Computational Science Symposium has established a series of Working Groups to meet the challenges related to the access and review of data which supports product development. The group works on possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science for product development. (PhUSE is the Pharmaceutical Users of Software Exchange, a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.) In particular, the Standard Script Development Working Group has established an "open source" platform for the collaborative development of specialized program code to be used as analytical tools for the clinical trial research, reporting, and analysis. This presentation will provide an overview of the platform, a review of what's been done so far, and a look at future plans.