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 | |
---|---|---|
Complete the Docker POC Project | Q4 2020 | |
Kick off the Docker pilot for a real submission | Q4 2020 | |
White Paper on best practices for interactive analyses for decision making & submissions | Q4 2020 NIHPO API formal release | Q22021 |
White Paper on state of the art of Biopharma Data Synthesis | Q2 2021 |
| ||||||
Python data set generator and the web interface to user configuration for the data set engine contributions continue 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 |