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Project Scope

This project team will create a White Paper with recommendations for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for outliers/shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options



Project LeadsEmail

Wei Wang 

wang_wei_v@lilly.com

Charles Beasley

charlesmbeasleyjr@msn.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.eu


Status
colourBlue
titleCurrent Status
 Q42020

Recently presented at the CSS and new team formed. Kick off meeting taken place and will look to review timelines


DeliverablesTimelines




Project MembersCompany
Amelia PangSanofi
Mary NilssonEli Lilly
Mercy NavarroGene
Nancy BruckenCSG-Inc
Nhi BeasleyFDA
Sumit PradhanIndustry