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 | |
Nicola Newton, PHUSE Project Assistant |
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|---|---|---|---|---|---|---|
White paper will be drafted based on interviews with experts on clinical safety data review by end of Q4 .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. |
| 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 | 2023Q1 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 |