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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,

Alex Pearce, PHUSE Project Assistant

)

nicky@phuse
alexandra@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.

Q2 2024

  • 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