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 michael.rubison@capish.com
Melissa Wissner Project Co-Lead MDSOL mwissner@mdsol.com
Lauren White Project Coordinator PhUSE lauren@phuse.eu
Alastair Clewlow Participant Lundbeck ALCL@lundbeck.com
Amy Matcho Participant JNJ amatcho@its.jnj.com
Arlene Coleman Participant Pfizer Arlene.Coleman@pfizer.com
Artem Andrianov Participant Cyntegrity Artem.Andrianov@cyntegrity.com
Ashish Kumar Participant Alkermes ashish.kumar@alkermes.com
Barbara Ramambason Participant Phastar Barbara.Ramambason@phastar.com
Bereket Tesfaldet Participant FDA Bereket.Tesfaldet@fda.hhs.gov
Bharath Sunkavalli Participant InventivHealth bharath.sunkavalli@inventivehealth.com
Bob Friedman Participant Xybion BFriedman@xybion.com
Crystal Allard Participant FDA Crystal.Allard@fda.hhs.gov
Dale Plummer Participant Vanderbilt Dale.Plummer@vanderbilt.edu
Dawn Kaminski Participant eclinical solutions dkaminski@eclinicalsol.com
Dragomir Ivanov Draganov Participant Roche dragomir_ivanov.draganov@roche.com
Eric Herbel Participant I-review Eherbel@i-review.com
Grace Lu Participant Astrazeneca Grace.Lu@astrazeneca.com
Hari J Vardhan Participant Chiltern hari.vardhan@chiltern.com
Heather Stevens Participant Chiltern Heather.Stevens@chiltern.com
Ingeborg Holt Participant Industry Ingeborghotl@gmail.com
Jatin Patel Participant Parexel jatin.patel@parexel.com
Jasmine Sen Participant Bayer Jasmine.Sen@bayer.com
Jeff Kim Participant Accenture Jeffrey.C.Kim@accenture.com
Jinesh Shah Participant Georgetown jcs222@georgetown.edu
Joan Buenconsejo Participant Astrazeneca Joan.Buenconsejo@astrazeneca.com
Josephine Fong Participant Gene Jfong@gene.com
Karnika Dalal Participant Bayer Karnika.Dalal@bayer.com
Kevin Lee Participant Industry Kevin.Kyosun.Lee@gmail.com
Lisa Kammerman Participant Astrazeneca Lisa.Kammerman@astrazeneca.com
Lothar Tremmel Participant Astrazeneca Lothar.Tremmel@astrazeneca.com
M Mehra Participant Qbiop Mmehra@qbiop.com
Melissa Binz Participant Pfizer Melissa.A.Binz@pfizer.com
Mitch Cooper Participant Lilly Mitch.Cooper@lilly.com
Michael Johnson Participant FDA Michael.Johnson@fda.hhs.gov
Paul Schuette Participant FDA Paul.Schuette@fda.hhs.gov
Pam Howard Participant Iconplc Pam.Howard@iconplc.com
Peter Hu Participant Merck Peter_Hu@merck.com
Rebeka Revis Participant Lilly Rebeka_Revis@lilly.com
Rinki Jajoo Participant Merck Rinki_Jajoo@merck.com
Sangeeta Bhattacharya Participant Novartis Sangeeta.Bhattacharya@novartis.com
Shafi Chowdhury Participant Shafi Consultancy Shafi@shaficonsultancy.com
Sharon Wang Participant Gene Wangx3@gene.com
Simon Walsh Participant Novartis Simon.Walsh@novartis.com
Siddartha Kondapally Participant Vita Data Sciences skondapally@softworldinc.com
Srinivas Veeragoni Participant Bayer Srinivas.Veeragoni@bayer.com
Steve Wilson Participant FDA Stephen.Wilson@fda.hhs.gov
Susan.Kramlik Participant Merck Susan.Kramlik@merck.com
Suzanne Tautz Participant Astrazeneca Suzanne.Tautz@astrazeneca.com
Wei Wang Participant Lilly Wang_Wei_V@lilly.com
Xiangyen Wang Participant Gene Wang.Xiangyun@gene.com
Zachary Skrivanek Participant Lilly Skrivanek_Zachary@lilly.com
Kishore Pothuri Participant Vita Data Sciences kpothuri@vitadatasciences.com
Sabine Jonas Participant Business and Decision Life Sciences sabine.jonas@businessdecision.be
Roxane Debrus Participant Business and Decision Life Sciences roxane.debrus@businessdecision.be
Benjamin Devriendt Participant Business and Decision Life Sciences benjamin.devriendt@businessdecision.be
Kevin Cahill Participant EPL Inc kcahill@epl-inc.com
Karl Brand Participant Bayer karl.brand@bayer.com
Susan Duke Participant FDA susan.duke@fda.hhs.gov
Catherine Li Participant FDA catherine.li@fda.hhs.gov
Anupama Sheoran Participant Bayer anupama.sheoran@bayer.com
Gaoyang Li Participant Bayer gaoyang.li@bayer.com
Eunice Ndungu Participant Merck eunice_ndungu@merck.com
Stella Munuo Participant Astrazeneca Stella.Munuo@astrazeneca.com
Sreekanth Gudapati Participant eclinical solutions sgudapati@eclinicalsol.com

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 (wendy@phuse.eu) 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