Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research, leading to better data interpretations and increased efficiency in the clinical/non-clinical drug development and review processes.
Move From Everyone Building Their Own Tools to Shared Tools
The use and sharing of scripts between organizations has many regulatory implications including software licensing, Programming standards, and solution validation. The working group has projects and sub teams devoted to these considerations.
Collaboration Platform and Shared Reusable Code and Test Data Library
The working Group has established the PhUSE GitHub Repository to hoststandard scripts for data transformations and analyses across and within therapeutic areas, as well as for exploratory analyses. More recently, the test dataset factory project has uploaded the SDTM and ADaM datasets generated by their team.