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for analysis outliersshifts
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

Wei Wang 

wang_wei_v@lilly
Charles Beasley, Beasley Pharmaceutical and Biotechnology Consultingcharlesmbeasleyjr@msn.com

Charles Beasley

charlesmbeasleyjr@msn.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.eu
Christopher Smith, FDAchristopher.smith2@fda.hhs.gov
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q42020Recently presented at the CSS and new team formed. Kick off meeting taken place and will look to review timelinesDeliverablesTimelinesProject MembersCompanyAmelia PangSanofiMary NilssonEli LillyMercy NavarroGeneNancy BruckenCSGNhi BeasleyFDA

Q3 2023

Project Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023
Sumit PradhanIndustry