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 Beasley (Beasley Pharmaceutical and Biotechnology Consulting)charlesmbeasleyjr@msn.com

Wei Wang (Eli Lilly)

wang_wei_v@lilly.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global

Objectives & Deliverables 

Timelines 

White Paper (initial scope) 

Q3 2022

CURRENT STATUS Q3/4 2022

Align next steps for this project in Q1 202 

Project MembersOrganisation
Amelia PangSanofi
Darshan BhattIndustry
Edward RauschEli Lilly
Hongli LuMerck
Kirthi RangarajuPfizer
Mary NilssonEli Lilly
Maria DaltonGSK
Mercy NavarroGenentech
Miri Kramer Mediwound
Nancy BruckenCSG
Nhi BeasleyFDA
Raj PhadtareCorvus Pharmaceuticals
Robert (Mac) GordonJanssen Research & Development
Sumit PradhanIndustry
Shayami 

Thanabalasundrum

Eli Lilly
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