Data Visualisations for Clinical Data

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Project Overview

The FDA Guidance on a Risk-Based Approach to Monitoring (August 2013) opened the door to using scientifically founded monitoring solutions as alternatives to 100% source verification of clinical data. Individual companies have proposed a range of opportunities to look at the applicability of data visualization within the pharmaceutical environment that addresses cross-domain questions and insight associated with RBM.

The following areas of interest and exploration will be addressed:

1: RBM Guidance: Standards, References and Global Vision

2: Data Visualization as a RBM Tool for Site Performance

3: Interactive vs. Static Visualizations

4: RBM Guidance: Monitoring, Compliance, Best Practices and Training

Current Projects

Best Practices for Interactive Analyses for Decision Making & Submissions

Use of Data Visualisation for Subject Level Data Review

Use of Data Visualisation for Data Anomaly Detection

Project Leads & Members

Name Role Organization E-mail
Michael Rubison Project Co-Lead Capish
Melissa Wissner Project Co-Lead MDSOL
Lauren White Project Coordinator PhUSE
Alastair Clewlow Participant Lundbeck
Amy Matcho Participant JNJ
Arlene Coleman Participant Pfizer
Artem Andrianov Participant Cyntegrity
Ashish Kumar Participant Alkermes
Barbara Ramambason Participant Phastar
Bereket Tesfaldet Participant FDA
Bharath Sunkavalli Participant InventivHealth
Bob Friedman Participant Xybion
Crystal Allard Participant FDA
Dale Plummer Participant Vanderbilt
Dawn Kaminski Participant eclinical solutions
Dragomir Ivanov Draganov Participant Roche
Eric Herbel Participant I-review
Grace Lu Participant Astrazeneca
Hari J Vardhan Participant Chiltern
Heather Stevens Participant Chiltern
Ingeborg Holt Participant Industry
Jatin Patel Participant Parexel
Jasmine Sen Participant Bayer
Jeff Kim Participant Accenture
Jinesh Shah Participant Georgetown
Joan Buenconsejo Participant Astrazeneca
Josephine Fong Participant Gene
Karnika Dalal Participant Bayer
Kevin Lee Participant Industry
Lisa Kammerman Participant Astrazeneca
Lothar Tremmel Participant Astrazeneca
M Mehra Participant Qbiop
Melissa Binz Participant Pfizer
Mitch Cooper Participant Lilly
Michael Johnson Participant FDA
Paul Schuette Participant FDA
Pam Howard Participant Iconplc
Peter Hu Participant Merck
Rebeka Revis Participant Lilly
Rinki Jajoo Participant Merck
Sangeeta Bhattacharya Participant Novartis
Shafi Chowdhury Participant Shafi Consultancy
Sharon Wang Participant Gene
Simon Walsh Participant Novartis
Siddartha Kondapally Participant Vita Data Sciences
Srinivas Veeragoni Participant Bayer
Steve Wilson Participant FDA
Susan.Kramlik Participant Merck
Suzanne Tautz Participant Astrazeneca
Wei Wang Participant Lilly
Xiangyen Wang Participant Gene
Zachary Skrivanek Participant Lilly
Kishore Pothuri Participant Vita Data Sciences
Sabine Jonas Participant Business and Decision Life Sciences
Roxane Debrus Participant Business and Decision Life Sciences
Benjamin Devriendt Participant Business and Decision Life Sciences
Kevin Cahill Participant EPL Inc
Karl Brand Participant Bayer
Susan Duke Participant FDA
Catherine Li Participant FDA
Anupama Sheoran Participant Bayer
Gaoyang Li Participant Bayer
Eunice Ndungu Participant Merck
Stella Munuo Participant Astrazeneca
Sreekanth Gudapati Participant eclinical solutions

Project Updates

Presentation by Lori Convy on File:Phuse TransCelerate Overview LoriConvy.pdf

Presentation by Melissa Wissner on Data Visualisation & Site Performance

Slides from CSS 2017 Monday 20th March
Slides from CSS 2017 Tuesday 21st March

File:2017-11-18 FHIR DataVisualisation.pptx

Objectives and Timelines

Objective Timeline
Data Gathering – Assign to above groups – Report Bi-Monthly April – September 2016
Prepare comparisons – Discuss questions and problems September – December 2016
Prepare White Paper with findings January – March 2017

Project Activities

Bi-weekly meetings: Tuesdays (starting May 17, 2016), 10 am ET - Everyone is invited.

Please contact Wendy Dobson ( for a GoToMeeting Invite.

Activity Link to Materials
May 17th Meeting May 17, 2016 Minutes
May 31st Meeting May 31, 2016 Minutes
September 5th Meeting September 5th 2017 Minutes
September 19th Meeting September 19th 2017 Minutes
October 3rd Meeting October 3rd 2017 Minutes
November 28th Meeting November 28th 2017 Minutes
December 12th Meeting December 12th 2017 Minutes
January 11th Meeting January 11th 2018 Minutes
January 23rd Meeting 2018 January 23rd 2018 Minutes
February 13th Meeting 2018 February 13th 2018 Minutes
February 27th Meeting February 27th 2018 Minutes
March 13th Meeting March 13th 2018 Minutes
March 27th Meeting March 27th 2018 Minutes
April 10th Meeting April 10th 2018 Minutes
May 5th Meeting May 5th 2018 Minutes
June 12th Meeting June 12th 2018 Minutes
June 26th Meeting June 26th 2018 Minutes
July 11th Meeting July 11th 2018 Minutes
July 24th Meeting July 24th 2018 Minutes
September 11th Meeting September 11th 2018 Minutes

Archived Content

2015-2016 Data Visualizations Work - LINK to Archived Data Visualization Materials