Conference 2014

PHUSE 2014 was the 10th PHUSE Annual Conference and was held at the Grange Tower Bridge Hotel from the 12th to 15th October and was chaired by Pierre Mayeur (IDDI).

Watch the 2014 Annual Conference Video

Best in Stream Winners are highlighted in bold text.

2014 Papers / Presentations

Applications and Software Development

AD01: Patchwork - A Creative Approach to Revise Existing Validation Methods
Anja Feuerbacher, Roche
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AD02: How to Improve Performance on SDD 3.5
Rob Wartenhorst, Novartis
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AD03: WISE a World Wide Integrated SAS Environment for Today and Beyond
Alain Vasseur & Christelle Le-Beaudour, Sanofi
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AD04: R for SAS Programmers: It's Different, but Friendly
Friedrich Schuster, HMS Analytical Software
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AD05: Exploring Safety and Diagnostic Data using Self-Organising Maps
Colin de Klerk, InVentiv Health Clinical
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WINNER AD06: Agile Project Management in a Regulated Environment
Alistair Dootson & Amol Waykar, d-Wise
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AD07: SAS in Clinical Trial - A Relook at Project Management, Tools and Software Engineering
Sameera Nandigama, InVentiv Health Clinical
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AD08: Metadata Design for Analysis and Reporting
Gopinath Viswanathan & Giri Balasubramanian, PRA International
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AD09: Automated Generation of Program Documentation by Means of Tagged SAS Comments and Metadata for Integrated Analysis
Thomas Wollseifen, InVentiv Health Clinical
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AD10: Actionable Clinical Data Insights: The Key to Improved Collaboration and Workflow
Rick Morrison, Comprehend Systems
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Coders Corner

CC01: Automating Production of the Blankcrf.pdf
Joseph Rowley & Walter Hufford, Novartis
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CC02: Dequote Me On That: Using the Dequote Functions to Add some Friendliness to SAS Macros
John Hendrickx, Danone Nutrica Research
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CC03: Overview of SAS Proc Format and Code for Combining Formats Catalogs
Douglas Staddon, Cmed
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CC04: Big Data - Step Towards High Performance Analytics
Dhiraj Dabhi, InVentiv Health Clinical
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CC05: A Dynamic Approach to File Organisation using DOS within SAS
Michael Tang, PPD
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CC06: Call Execute: Let Your Program Run Your Macro
Artur Usov, OCS Consulting
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WINNER CC07: Define your Own SAS Functions for Date and Numeric Validation using PROC FCMP
Jason Smith, Argo Analytics
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CC08: Using SAS Arrays
Ruurd Bennink, OCS Consulting
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CDISC and Industry Standards

CD01: Challenges with the Interpretation of CDIOSC - Who Can We Trust?
Linda Palm Simonsson, I-Mind
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CD02: Findings About: "Findings About"
Madhura Khare, Cytel
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WINNER CD03: ADaM Standards: What's New?
Gavin Winpenny, Business & Decision Life Sciences
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CD04: How the Release of the Therapeutic Area Asthma User Guide Affects an Ongoing Submission
Nick De Donder, Business & Decision Life Sciences
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CD05: Handling Non-Standardised Questionnaires
Anne Sophie Beckx & Eanna Kiely, Business & Decision Life Sciences
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CD06: Implementation of CDISC ADaM in the Pharmacokinetics Department
Joanna Magielse, Tineke Callant & Elke Vansnick, SGS Life Sciences Services
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CD07: Is Your Clinical Data Standards Library Ready for Change? Adapting to TA Specific Standards
Lauren Shinaberry, Business & Decision Life Sciences
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CD08: Models, Metadata and Messaging: Exploring Standards Governance in the CDISC Era
Ken Stoltzfus, Accenture Life Sciences
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CD09: Successfully Embracing Challenges to CDISC Standards
Elke Sennewald, Theorem Clinical Research
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CD10: Every Study is Special! - Governing Data Standards
Chris Price, Roche & Elizabeth Nicol, Genentech
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CD11: Using CDISC Validation Tools in a Validated Hosted  Environment
Sandeep Juneja, SAS Institute
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CD12: Discover Define.xml
Mark Wheeldon, Formedix
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CD13: Looking for SDTM Migration Specialist
Angelo Tinazzi, Cytel
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CD14: Considerations in Creating Transparent SDTM-Based Datasets
Jerry Salyers, Richard Lewis & Fred Wood, Accenture Life Sciences
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CD15: CDISC Dataset-XML - A Dataset Structure for Clinical Trial Data Transport for Future Drug Submissions
Joerg Dillert, Oracle
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Coding Solutions

CS01: Don't Miss the Hidden Gems Among the New Features of SAS ODS for Report Creation
Patrick Warnat, HMS Analytic Software
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CS02: Presenting SAS Data Sets on the Web Using SAS ODS, JavaScript and jQuery
Volker Harm, Bayer Schering Pharma
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CS03: Creating Graph Collections with Consistent Colours Using ODC Graphics
Philip Holland, Holland Numerics
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CS04: Overview of Hash Object
Swarnalatha Gaddam, Cytel
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CS05: Leveraging R And Shiny for Point and Click ADaM Analysis
Ian Fleming, s-Wise
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CS06: How to Improve Your Figure. An Overview of Annotation Techniques in Graph Template Language
Konrad Zywno, InVentiv Health Clinical & Bartosz Kutlyla, SAS Institute
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WINNER CS07: Drug Exposure Plot: Tailored Approach to Display Ongoing Data
Mathias Lebreton, Novartis
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Data Handling

DH01: ADaM Conversions: The Good, The Bad and The Ugly
Carla Santillan & Jessica Minuke, Business & Decision Life Sciences
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DH02: Consistent Data Delivery
Thevaki Mahedevan, ICON
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DH03: SDTM in Business Intelligence
Mike Collinson, Oracle Health Sciences Consulting
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WINNER DH04: Data Challenges in Adaptive Trials
Claudio Garutti, Oracle Health Sciences Consulting
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DH05: Monitoring Clinical Trials with a SAS Risk-Based Approach
Laurie Rose, SAS Institute
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DH06: Do You Like What You See? - Understanding Data in Magnetic Resonance Imaging Studies
Oliver Wirtz, UCB BioSciences
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DH07: Study Data Handling: A CRO Experience
Paul Crean, ICON
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DH08: Metadata, Study Standards, Interoperability: Key Concepts Toward Compliance to FDA Guidance
Isabelle de Zegher, PAREXEL
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DH09: Challenges of Different MedDRA Versions for Integrated Data and Databases
Peter Bonata, Bayer Healthcare
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DH10: Dynamic Oceans and Static Poolings of Clinical Trial Data in NVx
Pantaleo Nacci, Novartis Vaccines
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Data Transparency

DT01: Welcome to the New World of Data Transparency
Chrissie Fletcher, Amgen
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DT03: Understanding that Data Transparency Matters: The Academic View
Sarah Nolan & Catrin Tudor-Smith, Liverpool University
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DT04: Data Transparency: Data De-identification and the Role of the Programmer
Jean-Marc Ferran, Qualiance
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WINNER DT05: A Day in the Life of a Data Sharing Specialist
Kelly Mewes, Roche
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DT06: A New Era: Open Access to Clinical Trial Data
Guillaume Breton, Novartis
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Health Outcomes and Epidemiology

HE01: Conjoint Analysis of Treatment Preference
Milena Balcerzak, PAREXEL
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HE02: From Gene Expression to Expression Cartography, Grade Correspondence Analysis Application in Class Comparison Studies
Edyta Winciorek, PAREXEL
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HE03: Evaluating the Tradeoff between Quality of Life through Quality-Adjusted Survival Analysis
Lawrence Rasouliyan, ICON Clinical Research
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HE04: Simple and Efficient Matching Algorithms for Case-Control Matching
Berber Snoeijer & Edith Heintjes, PHARMO Institute
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HE05: Analysis of Self-Reported Health Outcomes Data from Web-Based Media Sources
Mark Wolff, SAS Institute & Kenneth Lopiano, Statistical and Applied Mathematical Institute
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HE06: Cost-Effectiveness in Hospitals Using SAS
Ilias Pyrnokokis, OCS Consulting
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WINNER HE07: Oncology Efficacy Endpoints
Sarah Berenbrick, Quanticate
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Industry Starters

IS01: Clinical Study Data Processes @ LEO Pharma
Joergen Iversen,LEO Pharma
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IS02: Life as a New Programmer
Jeremy Gallien, Novartis
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IS03: MedDRA - Beyond that Basic AE Report. How SMQs and MedDRA Structure can Enhance Reporting
Pamela Giese, InVentiv Health Clinical
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WINNER IS04: Unuttered Questions of Statistical Programmers
Aparajita Dey, Cytel
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IS05: Frequency Tables - Aspects to Consider
Katja Glass, Bayer Pharma
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Management (No Papers available)

MA02: A Vision for the Future: Core Competencies for Statisticians and Programmers
James Johnson, Summit Analytical

MA03: The On-Going Evolutionary Changes of our Industry
Christian Mueller, Roche

MA04: Standards Driven Innovation
Frederik Malfait, IMOS Consulting

MA05: Programming and Statistics in the Academics Environment
Arne Ring, University of Leicester

MA06 (2 Presentations): 

Conferences: Ten Years Past, Ten Tears Future
Stephen Bamford, Business & Decision Life Sciences & James McDermott, Ab Tartarus

"Statistics and Computing for Health" A 10-year Bachelor of Science in South Brittany
Jean-Francoius Petiot & Cedric Frambour, German Institut Universitaire de Technologie de Vannes 

Professional Development & Training

PD01: What Makes one Project Successful and Another Stressful?
Colin Brown, Hearthought Enterprises
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PD02: Confessions of an Obsessive Compulsive Programmer
Diana Stuart, Cmed
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PD03: Work-Life Balance: Making it a Reality
Manjusha Gode & Ajay Sathe, Cytel
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PD04: Change Management - An ICON Approach and Case Study
Anagha Pradhan, ICON
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PD05: Lessons Learned by Comparing "using SAS" as and Epidemiological Researcher and "using SAS" as a Statistical Programmer
Joris Derks, OCS Consulting
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PD06: A New Trend in the Industry - Partnership between CROs and Pharma. Do we Know How to Work Together?
Kevin Lee, Accenture R&D
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PD07: Learnings and Evolutions of Risk Assessment Quality Control within Statistical Programming Group
Timothy Barnett, Roche
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PD08: Managing the Change - Evolving Statistical Programmers to Clinical Data Scientists
Sascha Ahrweiler, Bayer Healthcare
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PD09: Internship - First Step in Personal Development
Jaroslaw Parzych, Quanticate
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WINNER PD10: From SAS Programmer to Manager - Facilitating the Transition
Russell Gibson, InVentiv Health Clinical
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PD11: Development of Exploratory Statistical Programmers Based in India
Jan Stefanek, UCB BioSciences
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Poster Presentation

PP01: Reengineering a Standard Process form Single to Environment Macro Management
Guiseppe DiMonaco, UCB BioSciences
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PP03: How to Validate a SAS Macro - A Case Study
Edwin Ponraj Thangarajan & Giri Balasubramanian, PRA International
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PP04: What's Next in Version Control for SAS Programming Environments?
David Garbutt, NNIT
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PP05: From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials
Alexandre Mathis, Actelion Pharmaceuticals
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WINNER PP06: Implementation of Oncology Specific SDTM Domains
Jacintha Eben, SGS
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PP07: FLIPFLOP the Data: To Check Sustained Timepoint Occurrences
Rucha Landge, InVentiv Health Clinical
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PP08: Backward Selection: Immunity Test of Covariates
Prathamesh Athavale, InVentiv Health Clinical
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PP09: Medical Data Review and Exploratory Data Analysis using Data Visualisation
Joel Allen & Vinod Kerai, Roche
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PP10: Data Transparency through Metatada Management
Judith Goud & Julie Smiley, SOA Software
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PP11: Analysis of Time to FDA Medwatch Safety Alert for Therapeutic Monoclonal Antibodies
Pavla Kadlecová & Vid Stanulovic, Aprova, & Ladislav Pecen, International Clinical Research Centre, St. Anne's Hospital
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PP12: NONMEM - A Programmers Point of View
Raghu Kishor Koukuntla, Cytel
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PP13: Time to Event Analysis
Michaela Mertes, Roche
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PP14: The PHUSE Therapeutic Area Wiki Page
Jothy Kalathiparampil & Oliver Wirtz, UCB BioSciences
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PP15: QC: Manual vs Program - A Personal View
Helen Nicholson, Cmed
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PP16: Population Segmentation in a Healthcare Environment
MaryAnne DePesquo, BlueCross BlueShield of Arizona
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PP17: Representation of Foundation CDISC Standards Using RDF
Geoff Low, Medidata Solutions, Frederik Malfait, IMOS Consulting & Scott Bahlavooni, Biogen Idec
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PP18: Migrating Between SAS Clinical Standards Toolkit™ Versions 1.5 and 1.6. Is that an African or a European Swallow?
Gene Lightfoot, SAS Institute
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PP19: Clinical Site Dataset in eSubmissions to the FDA
Stefanie Sturm, Accovion
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PP20: SDTM Mapping Becomes more EASY with SAS Clinical Data Integration
Saumilkumar Tripathi, Cytel
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PP21: My Transition From Placement Student to Permanent Employee Within the Same Company
Robyn Rosser, Amgen
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PP22: Interactive Data Visualisation of Adverse Event Clinical Trial Data with the D3.js. Script Library
Johann Laurent & Hugh McDevitt, Novartis
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PP23: Collaborative Development of an Open Source Repository for Standardised Analysis Using Cloud Services
Michael Carniello, Astellas, Hamming TU, Accenture & Dirk Spruck, Accovion
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PP24: Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports
Mary Nilsson, Eli Lilly & Company, Ann Croft, Leo Pharma & Dirk Spruck, Accovion
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PP25: Data Transparency: Moving from Bad Pharma to Good Science
Gary Hearfield, Amgen & Katherine Tucker, Roche
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PP26: Building the Next Generation
Michael Hall, Roche
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PP27: Outsourcing Version 4.0a - The Changing Landscape of Sponsor's Expectation
Pooja Shinde & Sangeet Kumar, Cytel
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PP28: Communication - Building the Invisible Bridge
Anindita Bhattacharjee, Cytel
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PP30: PROC EASTMONITOR - A SAS Add-on for Monitoring Adaptive Clinical Trials
Sheetal Solanki & Ajay Sathe, Cytel
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PP31: Concept for a Clinical Trial Reporting System
Daniil Shliakhov, Experis Clinical A Manpower Group Company
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PP32: Accessing Study Results Online
Shafi Chowdhury & Mokhfur Chowdhury, Shafi Consultancy
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PP35: The Capish Information Model - Simplify Access to Your Data
Anna Berg & Catharina Dahlbo, Capish Nordic
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PP36: Lowering the Barriers to Cloud Adoption
Tony Hewer, Medidata Solutions
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PP37: Technology Trends with the Potential to Change Clinical Development
Chris Olinger, d-Wise
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Regulatory

RG01: Signal Detection of Misconduct in Clinical Trials
Geoffrey Mann, SAS Institute JMP Division
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RG02: Transparency in the Time of Constant Change
Todd Case, Biogen Idec
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WINNER RG03: Japanese Submission/Approval from Programming Perspective
Ryan Hara, Novartis
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RG04: Submitting Summary Level Site Data: Overview, Implementation and Case Studies
Robert Woolson & Jeff Abolafia, Rho
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RG05: FDA Guidance on Standardised Study Data for Electronics Submissions
Lauren Shinaberry & Eanna Kiely, Business & Decision Life Sciences
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RG06: Traceability: Plan Ahead for Future Needs
Sandra Minjoe, Accenture
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RG07: The Quality System in Good Pharmacovigilance Practice (GVP)
Veronique Chapalain, Keyrus
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RG08: Update on Regulatory Guidance: Data Standardisation Planning for Clinical Development Programs
James Johnson, Summit Analytical
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Software Demonstrations

SD01: R and Revolution R Enterprise in Regulatory Environments
Eike Nicklas, HMS Analytical Software & Neil Miller, Revolution Analytics
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SD02: Automated SDTM Creation and Discrepancy Detection Jobs: The Numbers Tell the Tale
Joris De Bondt, SGS Life Science Services
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SD03: Why Don't You Define It?
Nick De Donder & Anne-Sophie Bekx, Business & Decision Life Sciences
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SD04: Outsourcing Pharmacovigilance:Web-based Interface to Develop a Collaborative and Interactive Partnership between Sponsor and Partners
Nicolas Limbos & Emeliine Pierre, Keyrus Biopharma
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SD05: An Introduction to SAS® Visual Analytics for the Health Care Sector
Rhian Pilling, Amadeus Software
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SD06: Introducing Clinic Automation in a Phase I Unit with End-to-End eSource Data Processing
Wim Verrweth, SGS Life Science Services
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SD07: Risk Based Monitoring through Integrated Clinical Development Platform
Siat Rama Swamy Peddibohyina & Shailesh Joshi, MaxisIT
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SD08: SAS Visual Statistics
Andy Bayliss, SAS Institute
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SD09: Spotfire for Clinical and Translational Medicine
Gerard Conway, PerkinElemer
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Statistics and Pharmacokinetics

SP01: Checking Symmetry in Predefined Time Assessments
Antonio Nieto & José Luis Jiménez Moro, PharmaMar
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SP02: Inverse Probability of Censoring Weighting for Selective Crossover in Oncology Clinical Trials
José Luis Jiménez Moro & Javier Gómez Garcia, PharmaMar
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WINNER SP03: Small Sample Bayesian Factor Analysis
Dirk Heerweghm, Business & Decision Life Sciences
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SP04: Multiple Imputation: Better than Single Imputation in Pain Studies
Ashik Chowdhury, Cytel
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SP05: Analysis of Time to FDA Medwatch Safety Alert for Therapeutic Monoclonal Antibodies
Pava Kadlecova & Vid Stanulovic, Aprova & Ladislav Pecen, International Clinical Research Centre, St. Ann's Hospital
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SP06: Biomarker as Essential Part of Clinical Development
Renuka Chinthapally, Cytel
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SP07: Examining the Tests Behind Survival Curves
Hans-Dieter Spies, InVentiv Health Clinical
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SP08: Forest Plot: W**3 + H**2 What, Why, When and How to Generate and How to Interpret
Petra Van Wetten, Novartis
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Technical Solutions

TS01: Something for Nothing! Converting Plots from SAS/GRAPH® to ODS Graphics
Philip Holland, Holland Numerics
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TS02: Creating a Personal View on the Data via using a Virtual Private Database
Sébastien Roland & Bart van Win, Business & Decision Life Sciences & Jean-Marc Ferran, Qualiance
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TS03: Techniques for Writing Robust R Programs
Martin Gregory, Merck Serono
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TS04: Running OpenCDISC from SAS
Mark Crangle, ICON
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TS05: SANOFI Clinical Data Integration Solution as Part of SDTM Creation
Nadine Mourin, Sanmofi, Hasnaa Likaoui, Keyrus & Melissa Martinez, SAS Institute
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WINNER TS06: Reduce Programming Time with Reusable Templates
Cathal Gallagher & Karen Hitchmough, d-Wise
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TS07: Managing Custom Data Standards in SAS® Clinical Data Integration
Melissa Martinez, SAS Institute
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TS08: Manage your SAS Drug Development Environment
Bart van Win & Sébastien Roland, Business & Decision Life Sciences & Jean-Marc Ferran, Qualiance
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TS09: A World of Clinical Data at Your Fingertips
Mahdi About, Novartis & Karma Tarap, Independent
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TS10: Online Endpoint Adjudication in Oncology
Jacintha Eben & Tine Seeuws, SGS Life Science Services & Simon Hawken, Merge 
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Trends and Technology

TT01: A Day in the Life of an RDF Curator
Josephine Anne Gough, Roche
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TT02: Sharing and Building Sponsor-Specific CRF's - No Paper Required
Scott Bahlavooni, Biogen Idec & Retha Gerber, Quintiles
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TT03: A Primer on Converting Analysis Results Data to RDF Data Cubes using Free and Open Source Tools
Tim Williams, UCB BioSciences
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TT04: Multi-Sponsor Data Transparency: A Group Approach to Sharing
Bill Gibson, SAS Institute
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TT05: Sensor data in Patient Health: Lessons Learneds
Geoff Low, Medidata
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TT06: How Transparency is Changing the Way an Entire Industry Thinks about Data
David Handelsman, d-Wise
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TT07: Big and Bigger
Dimitri Kutsenko, Entimo
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WINNER TT08: The Application of Directed Graphs to Clinical Development
Ian Fleming, d-Wise
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University Day

UD01: From Sheffield Hallam to Switzerland via Strasbourg: A Career Path in the Pharmaceutical Industy
Roy Ward, Novartis
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UD02: Statistical Programming for Dummies
Nicola Tambascia & Sven Greiner, Accovion
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UD03: A New Starter's Experience as a Statistical Programmer
Carolyn Nixon, Roche
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UD04: Collaboration Versus Conflict: Building Successful Working Relationships
Diana Stuart, Cmed
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UD05: Misinterpretation of Statistics
John Salter, Teslar Consulting
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UD06: New Starter Models for Pharmaceutical Companies and Clinical Research Organisation (CROs)
Lovemore Gakava, StatsProgAnalysis
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