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 kirann Boddu (Takeda) | |
Nicola Newton (PHUSE, Project Assistant) |
White Paper on best practices for interactive analyses for decision making & submissions
Yang Yu
| ||||||
|---|---|---|---|---|---|---|
Aim 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. |
| 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
Bayer
Karan Dheer
Karl Brand
Project Members
Mary Nilsson
Sarepta Therapeutics
Nagadip Rao
Eliassen Group
Phil Bowsher
Raj Kiran Boddu
Takeda
Rinki Jajoo
Shiva Katepilli
Suhas Ravindra
Sucharita Pilli
Vishal Shah
Wei Wang
| 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 | 2023 |