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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
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global

Objectives & Deliverables

Timelines



NIHPO API formal releaseQ3 2021

White Paper on state of the art of Biopharma Data Synthesis 

Q4 2021 

Status
colourBlue
titleCurrent Status
 Q3/4 2022

Project currently on hold.​



VCA-Plus
Objectives & DeliverablesTimelines
NIHPO API formal releaseQ3 2021

White Paper on state of the art of Biopharma Data Synthesis 

Q4 2021 

Project Members 

Organisation 

Alexey Kuznetsov

GSK

Cynthia Stroupe

UCB

Jessica Dai

Vertex
Mazibuko NtinteloIndustry

Nancy Brucken

CSG

Peter Schaefer