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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

CURRENT STATUS Q12021

Strategy in place to create White Paper (won’t be a version 2) but an appendix/supplement of Version 1.
Objectives & DeliverablesTimelines
Users guide or White PaperQ32021
Project MembersOrganisation
Amelia PangSanofi
Darshan BhattIndustry
Edward RauschEli Lilly
Hongli LuMerck
Mary NilssonEli Lilly
Maria DaltonGSK
Mercy NavarroGenentech
Nancy BruckenCSG
Nhi BeasleyFDA
Raj PhadtareCorvus Pharmaceuticals
Robert (Mac) GordonJanssen Research & Development
Sumit PradhanIndustry
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