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Project Scope

This project team will create a users guide or 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
Charles Beasleycharlesmbeasleyjr@msn.com

Wei Wang 

wang_wei_v@lilly.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global

CURRENT STATUS Q42020

Recently presented at the CSS and new team formed. Kick off meeting taken place and will look to review timelines
DeliverablesTimelines
Users guide or White PaperQ32021
Project MembersCompany
Amelia PangSanofi
Darshan BhattIndustry
Hongli LuMerck
Mary NilssonEli Lilly
Mercy NavarroGene
Nancy BruckenCSG
Nhi BeasleyFDA
Raj PhadtareCorvus Pharma
Sumit PradhanIndustry
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