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Project Scope

Leverage Visual Analytics in our submission package to improve interactions between regulatory agencies and sponsors for a fast and effective review of submitted data and analyses.

Project Leads

Email

Zachary Skrivanek

skrivanek_zachary@lilly.com

Xiangyun 'Sharon' Wang

wang.xiangyun@gene.com

Lauren White (PHUSE Project Coordinator)lauren@phuse.global



Key Milestones 

ObjectiveTimeline
Complete the Docker POC Project On hold
Kick off the Docker pilot for a real submission On hold

White Paper on best practices for interactive analyses for decision making & submissions

Q4 2020 


CURRENT STATUS Q42020

Continuing to write the White Paper, docker/Shiny portion of the project on hold, looking for new FDA representative. 

Resources
DevOps in Action, Containers@Bayer- Presentation by Karl Brand 21-03-19

Project Members 

Organisation 

Catherine Xiao

Gilead

Douglas Warfield

Integrated Clinical Systems

Eric Herbel

Integrated Clinical Systems

Gaoyang Li 

Bayer

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Karl Brand 

Bayer
Maria Dalton GSK

Mary Nilsson 

Eli Lilly
Mominul Islam 

Sarepta

Nagadip Rao 

Elissen

Project Members 

Organisation 

Phil Bowsher

Rstudio

Raj Kiran Boddu 

Takeda

Hari J Vardhan 

Chiltern

Iraj Mohebalian  

Bayer

Rinki Jajoo 

Merck

Shiva Katepilli  

Sunovion 

Vishal Shah 

Sunovion

Wei Wang 

Eli Lilly

Yang Yu 

Sunovion
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