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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 | |
|---|---|
Zachary Skrivanek | |
Xiangyun 'Sharon' Wang | |
Lauren White (PHUSE Project Coordinator) |
| Objectives and 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 | Q2 2021 |
| ||||||
|---|---|---|---|---|---|---|
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. |
| 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 | Organisation |
|---|---|
| Ari Siggaard Knoph | Novo Nordisk |
| Bhavin Solanki | Bayer |
| Darshan Bhatt | Industry |
Catherine Xiao | Gilead |
Douglas Warfield | FDA |
Eric Herbel | Integrated Clinical Systems |
Gaoyang Li | Bayer |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
Karl Brand | Bayer |
| Mark Marino | Mark T Marino Consulting |
| Maria Dalton | GSK |
Project Members | Organisation |
|---|---|
Mary Nilsson | Eli Lilly |
| Mominul Islam | Sarepta Therapeutics |
Nagadip Rao | Elissen |
Phil Bowsher | RStudio |
Raj Kiran Boddu | Takeda |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
| Parag Wani | Novo Nordisk |
Rinki Jajoo | Merck & Co. |
Shiva Katepilli | Sunovion Pharmaceuticals |
| Vineet Sharma | Sarpeta |
Vishal Shah | Sunovion Pharmaceuticals |
Wei Wang | Eli Lilly |
Yang Yu | Sunovion Pharmaceuticals |