Best Practices for Interactive Analyses for Decision Making & Submissions

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Project Overview

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

Name Role Organization E-mail
Xiangyun 'Sharon' Wang Project Lead Genetech/Roche
Zachary Skrivanek Project Lead Lilly

Project Participants

Name Role Organization E-mail
Catherine Xiao Participant Gilead
Douglas Warfield Participant FDA
Eric Herbel Participant Ireview
Gaoyang Li Participant Bayer
Hari J Vardhan Participant Chiltern
Iraj Mohebalian Participant Bayer
Karl Brand Participant Bayer
Paul Schuette Participant FDA
Raj Kiran Boddu Participant Takeda
Phil Bowsher Participant Rstudio
Rinki Jajoo Participant Merck
Shiva Katepilli Participant Sunovion Pharmaceuticals
Maria Dalton Participant GSK
Mary Nilsson Participant Lilly
Mominul Islam Participant Sarepta
Wei Wang Participant Lilly
Vishal Shah Participant Sunvion
Yang Yu Participant Sunovion
Nagadip Rao Participant Elissen

Project Updates

Date: Description of Update

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
technical proof of concept with interactive data visualization display January, 2018
submission with interactive data visualization display March, 2019
white paper on best practices for interactive analyses for decision making & submissions June, 2019

Project Activities

Best Practices Notebook:

DevOps in Action, Containers@Bayer- Presentation by Karl Brand 21-03-19

Meeting Minutes

Activity Link to Materials
Group 1 Minutes 2017-07-18 2017-07-18
Group 1 Minutes 2017-08-18 2017-08-18
Group 1 Minutes 2017-09-06 2017-09-06
Group 1 Minutes 2017-10-31 2017-10-31
Group 1 Minutes 2017-12-13 2017-12-13
Group 1 Minutes 2018-01-22 2018-01-22
Group 1 Minutes 2018-02-14 2018-02-14
Group 1 Minutes 2018-3-28 2018-03-28
Group 1 Minutes 2018-4-18 2018-04-18
Group 1 Minutes 2018-16-05 2018-05-16
Group 1 Minutes 2018-20-07 2018-20-07
Group 1 Minutes 2018-15-08 2018-15-08
Group 1 Minutes 2018-18-09 2018-18-09
Group 1 Minutes 2018-17-10 2018-17-10
Group 1 Minutes 2018-18-12 2018-18-12

Archived Content