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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 LeadsEmail

José Lacal (NIHPO)

jose.lacal@nihpo.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global
Objectives & DeliverablesTimelines
NIHPO API formal releaseQ3 2021

White Paper on state of the art of Biopharma Data Synthesis 

Q4 2021 


CURRENT STATUS Q3/4 2022

Project currently on hold.​

Project Members 

Organisation 

Alexey Kuznetsov

GSK

Cynthia Stroupe

UCB

Jessica Dai

Vertex
Mazibuko NtinteloIndustry

Nancy Brucken

CSG

Peter Schaefer

VCA-Plus
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