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 | |
|---|---|
Zachary Skrivanek, Eli Lilly | |
Xiangyun 'Sharon' Wang, Genentech | |
Raj Kiran Boddu, Takeda |
Kerry Robson, PHUSE Project |
Assistant |
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|---|---|---|---|---|---|---|
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| Objectives & Deliverables | Timelines |
|---|---|
| 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 |
| Status | ||||
|---|---|---|---|---|
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The White Paper is being restructured to focus on the mechanisms on how to share the interactive tools with the Health Authorities as part of regulatory review process and the learning experience from the two pilot projects. Most technical details such as ARDS, best practice will be shared via blog posts.
| 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 |
Project Members
Catherine Xiao
Gilead
Douglas Warfield
FDA
Eric Herbel
Gaoyang Li
Bayer
Hari J Vardhan
Iraj Mohebalian
Karl Brand
Project Members
Mary Nilsson
Sarepta Therapeutics
Nagadip Rao
Elissen
Phil Bowsher
Raj Kiran Boddu
Takeda
Hari J Vardhan
Iraj Mohebalian
Rinki Jajoo
Shiva Katepilli
Vishal Shah
Wei Wang
Yang Yu