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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

(

, Eli Lilly

)

skrivanek_zachary@lilly.com

Xiangyun 'Sharon' Wang

(

, Genentech

)

wang.xiangyun@gene.com

Raj

kirann

Kiran Boddu

(

, Takeda

)

raj-kiran.boddu@takeda.com

Nicola Newton (PHUSE,

Kerry Robson, PHUSE Project Assistant

)

nicky@phuse

kerry@phuse.global


Status
colourBlue
titleCurrent Status
Q1

2023Aim to promote the use of ARDS (Analysis Results Datasets) as a solution to address validation and reproducibility for including interactive data display in submission. Eli Lilly plans to pilot interactive data display in submission with PDMA as the next step.

2024

  • Publishing WP
  • Planning for the next stage of the project







Objectives & DeliverablesTimelines
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

Q1 2024


Published Deliverables

Best Practice for Interactive Analysis for Submission – CSS Poster 2020

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

Interactive Data Visualisations for Decision Making in Submissions – PHUSE Webinar Wednesday 2019

Objectives & DeliverablesTimelinesComplete the Docker POC Project On holdKick off the Docker pilot for a real submission On hold

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

2023