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 |
Project Leads | |
|---|---|
Dante Di Tommaso | |
| Lauren White (PHUSE Project Coordinator) | lauren@phuse.global |
| Objectives and Deliverables | Timelines |
|---|---|
| NIHPO API formal release | Q22021 |
White Paper on state of the art of Biopharma Data Synthesis | Q2 2021 |
CURRENT STATUS Q42020 |
Working towards database "conformance" to ensure structural and content conformance of SDTM synthetic data using Pinnacle 21 evaluation. |
Project Members | Organisation |
|---|---|
Alexey Kuznetsov | GSK |
Cynthia Stroupe | UCB |
Jessica Dai | Vertex |
| Mazibuko Ntintelo | Industry |
Nancy Brucken | CSG |
Peter Schaefer | VCA-Plus |