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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 Leads

Email

José Lacal

jose.lacal@nihpo.com

Lauren White (PHUSE Project Coordinator)lauren@phuse.global
Objectives and DeliverablesTimelines
NIHPO API formal releaseQ2 2021

White Paper on state of the art of Biopharma Data Synthesis 

Q2 2021 


CURRENT STATUS Q22021

NIHPO API can synthesise partially conformant, credible datasets (CDISC).

Iterations to improve conformance and credibility are now the focus of the TDF team.

Discussion continues on support for user-specific “credibility” needs.

API for NIHPO synthetic building blocks to be released in Q32021.

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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