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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 Beasley
(
, Beasley Pharmaceutical and Biotechnology Consulting
)
charlesmbeasleyjr@msn.com
Christopher Smith
(
, FDA
)
christopher.smith2@fda.hhs.gov
Katie Warren (
Nicola Newton, PHUSE Project Assistant
)
katie@phuse

nicky@phuse.global


Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023

Status
colourBlue
titleCurrent Status

Q1

Q3 2023

Project

currently on hold

Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023
Project MembersOrganisationAmelia PangSanofiEdward RauschEli LillyHongli LuMerckKirthi RangarajuPfizerMary NilssonEli LillyMaria DaltonGSKMercy NavarroGenentechMiri Kramer MediwoundNancy BruckenCSGNhi BeasleyFDARahal Hamza IQVIARaj PhadtareCorvus PharmaceuticalsRobert (Mac) GordonJanssen Research & DevelopmentSumit PradhanIndustryShayami 

Thanabalasundrum

Eli LillyWei Wang Eli Lilly Xuewei (Sherry) Cui Eli Lilly