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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)

Paula Rowley (PHUSE Project Assistant)
Objectives & DeliverablesTimelines
NIHPO API formal releaseQ22021

White Paper on state of the art of Biopharma Data Synthesis 



  • 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 


Alexey Kuznetsov


Cynthia Stroupe


Jessica Dai

Mazibuko NtinteloIndustry

Nancy Brucken


Peter Schaefer

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