Project Scope |
Several Working Group projects develop and specify medical research methods, features or processes, and some even create software components or sub-systems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymised study data that are provided by project team members. The Test Dataset Factory project aims to provide test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts. |
Key Milestones
White Paper on best practices for interactive analyses for decision making & submissions
Project Leads |
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Dante Di Tommaso
dante.ditommaso@sanofi.com
Nicola Newton, PHUSE Project Assistant |
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Contributions to Python data set generator and the web interface to user configuration for the data set engine.
Project Members
Alexey Kuznetsov
GSK
Cynthia Stroupe
UCB
Jessica Dai
Nancy Brucken
CSG
Peter Schaefer
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.Q3/4 2022 |
Project currently on hold. |
Objectives & Deliverables | Timelines |
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NIHPO API formal release | Q3 2021 |
White Paper on state of the art of Biopharma Data Synthesis | Q4 2021 |