EU Connect 2019
10th–13th November

View the event brochure here.

Papers and Presentations 

 

To read Connect Stream descriptions, please click here. Best in Stream winners are highlighted in bold.

Keynote Speakers

Digital Biology: The Next Software Revolution is Life Itself
Elsa Sotiriadis PhD, RebelBio UK
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Sleep and the Ways of Measuring It
Neil Stanley PhD
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The Data of Fluffy Stuff and the Battle for Sanity
Simon Shepard, Optima-life
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Analytics Risk-based Monitoring (AR)

AR01: ICH E6 (R2): How Statistics Can Help to Improve Data Quality
Erik Doffagne, CluePoints
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AR02: A Data-driven and Cost-effective Approach Towards Risk-based Monitoring
Vineet Jain, Nimble Clinical Research
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AR03: ADaM-based Centralised Monitoring (winner)
Christian Christensen, Ferring Pharmaceuticals
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AR04: A Simulation-based Approach to Establishing Quality Tolerance Limits
Debbie Adkins & Susan Lovick, PHASTAR
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AR05: Data Everywhere: What Does Risk-based Monitoring Mean for Data Management?
Swapna Pothula, ICON
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AR06: A Three-pronged Approach to Central Monitoring to Identify Potential Risks and Ensure Data Quality
Marianne Van De Ven & Jill Ophoff, Janssen Research & Development
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Analytical & Statistics (AS)

AS01: Pharmacokinetic and Statistical Considerations in First-in-Human Clinical Trials (winner)
Joanna Magielse & Narine Baririan, SGS Life Sciences
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AS02: Dose-finding Schemes in Clinical Trials
Michael Brockmann, Chrestos Concept
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AS03: Bioequivalence Testing for Highly Variable Drug Products (HVDPs)
Jim Johnson, Independent
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AS04: Multiple Imputation as a Valid Way of Dealing with Missing Data 
Vadym Kalinichenko, Intego Group
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AS05: Beyond Missing Data Patterns: Augmenting PROC MI Tables with a Summary of Imputed Data
Lamine Signate, Covance
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AS06: Mixed Model Repeated Measures (MMRMs)
Mrudula Suryawanshi, Syneos Health
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AS07: Detriment Index-based Safety Ranking of Opioid Drugs
Samadhan Ghubade, Cytel
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AS08: Analysis of Crossover Studies in Patient Narratives
Rebecca Lyzinski & Geoffrey Mann, SAS Institute
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AS09: Incidence Density Sampling for Nested Case-control of Study Designs 
Rachel Tham & Quratul Ann, IQVIA
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AS10: SAS/STAT High-performance Statistics Procedures Contrasted with their Legacy Counterparts
Oscar Bortolami, GCE Solutions
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AS11: Analysis of Composite Endpoints Using the Win Ratio Method in SAS
Murat Ipek, PAREXEL International
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Application Development (AD)

AD01: Validating a CDISC Dataset at Development Time Using Pinnacle 21 CLI via SAS
David Meek, PHASTAR
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AD02: Design, Develop, Test and Document an R Package for Enrolment Modeling
Stephen Gormley, Amgen
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AD03: An Automation Proof of Concept of Periodic Reporting via R Shiny
Stephen Haesendonckx & Alexandra Papadopoulou, Janssen Research & Development
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AD04: The Trials and Tribulations of Automated SDTM Delivery
Edward Jones, Pharma Research Associates
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AD06: Semi Auto-generated Narratives
Bjarke Klein, Ferring Pharmaceuticals
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AD07: Customised AE Narratives Using JMP Clinical
Alastair Scarlett & Carol Vaughn, d-Wise
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AD08: Automated Test Framework for SAS Macros
Sven Prasse, Entimo
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AD09: Interfacing with Interfaces
Jeremy Teoh, Independent
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AD10: Efficient Implementation and Applications of PROC HTTP within Analysis and Reporting (winner)
Simon Todd, PHASTAR
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AD11: Automated Review of Metadata Standards, Data Checks and Trend Visualisation 
Giuseppe Di Monaco, UCB
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Coding Tips & Tricks (CT)

CT01: I Love SAS Logs (and You Can Too)
Sarah Berenbrinck, Independent
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CT02: Work Less, Do More: An Automated Approach to Define-XML Validation
Kai Wanke, OCS Life Sciences
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CT03: This Data Step Has Been Running for Ages - Can You 'Progress' It?
Jean-Michel Bodart, Business & Decision Life Sciences
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CT04: Don't Cha Wish Your Tracker Was Clean Like Mine?
Anisa Jeetoo, Veramed
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CT05: A Groovy Way to Enhance Your SAS (winner)
Karl Kennedy, GCE Solutions
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CT06: Innovative SQLs
Joseph Murphy, IQVIA
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CT07: Let's Look Further than One Observation: Applying Hash Objects for Typical Clinical Programming Tasks
Valeriia Oreshko, IQVIA
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CT08: Improving Your SAS Code Without SAS: Using Notepad++ to Super-charge Your Coding
Simon Purkess, Vivos Technology
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CT09: SAS Outputs in Excel Workbook Using ODS Excel
Meghana Mahajani, Cytel
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CT10: Validating R Functions Against SAS Outputs: How RTest Can Build a Bridge Allowing for Validation of R
Sebastian Wolf, Independent & Sergej Potapov, Roche
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CT11: Using the Source Code Control System GitHub to Manage Your SAS Code
Frank Biedermann, Grünenthal
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CT12: Understanding Regular Expression and its Application in SAS Using PRX (Perl regEx) Functions
Jagadish Katam, PAREXEL International
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CT13: Next Generation Collaboration: Using Tasks and Snippets in SAS Studio
Fatima Kassim, OCS Life Sciences
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CT14: Big SAS Code Navigation and Management
Fred Ross & Jessica Whittaker-Dixon, Quanticate
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Data Handling (DH)

DH01: Finding the Right Balance - Data Management Surveillance in a Fully Outsourced Partnership Model (winner)
Konstanze Morgenroth, Merck Healthcare
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DH02: SDTM Validation Tool
Anamaria Calai, Cmed
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DH03: Educating for the Future: Data Engineering Techniques
Guy Garrett, Achieve Intelligence
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DH04: Migrating to LSAF - Danone Nutricia Research's Journey
Paul Vervuren, Nutricia Research & Jean-Marc Ferran, Qualiance
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DH05: Laboratory Data: Issues with Myultiple Reference Ranges and Methods of Normalisation
Jessica Hoegg & Laura Marquis, Chrestos Concept
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DH06: GDPR: Risks and Recommendations from the PHUSE Data Transparency Working
Shannon Labout, Data Science Solutions & Arlene Coleman, Pfizer
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DH07: Governance for Global Data QC Checks
Kristien Nuyts, Janssen Research & Development
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DH08 Do Not Trust Your Own Computer-generated Numbers
Matthias Lehrkamp, Bayer
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DH09 May Your Data Pool Become Super Cool
Daniil Shliakhov & Anastasiia Tiurdo, Intego Group
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DH11 Addressing the Gap in Data Standards: Introducing the Aggregation Layer
Claudio Garutti & Marko Bomyer, Oracle Health Sciences
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Data Standards and Governance (DS)

DS01 How Can We Ensure Our Study Data is F.A.I.R. (Findable, Accessible, Interoperable and Reusable)?
Alana Harris, Roche
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DS03 Using a Digitised Study Design and Planning Process to Drive Clinical Development Automation
Barrie Nelson, Nurocor & Djenan Ganic, intilaris
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DS04 TS Does Not Mean T(o) S(uffer) – A Hands-on Guideline for a Better Understanding of the TS Domain
Kristina Zweier, Clinipace
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DS05 Implementation of SDTM IG v.3.3 for the Neurological Therapeutic Area
Daryna Khololovych, Intego Group
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DS06 Harmonising SDTM at the Source: Two Years Later
Helen Scanlon & Sue Huxtable, AstraZeneca
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DS07 Considerations when Representing Multiple Subject Enrolments in SDTM
Kristin Kelly, Pinnacle 21
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DS08 Clearing the Fog Surrounding LOINC (winner)
Jordan Bristow, PHASTAR
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DS09 Basics of Dataset Integration
Pradeep Kumar, Quanticate
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DS10 Define-XML Review: Failing to Plan is Planning to Fail
Robin Mann, GCE Solutions & Parveen Kumar, GenInvo
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DS11 CDISC 360: Continuing the Journey Towards End-to-End Automation
Peter Van Reusel, CDISC
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Data Visualizations (DV)

DV01 Data Visualisation: Where to Start?
Emma Moore, Roche
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DV02 Optimise PRO Data Analysis with an Interactive Approach
Tadeusz Lewandowski, Roche
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DV03 Using ODS LAYOUT to Create ABSOLUTE-ly Stunning Patient Profiles (winner)
Michael Allie, AstraZeneca
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DV04 Don’t Dream It: Be It – Harnessing SAS GTL to Produce Customised Composite Graphics
Nev Cope, AstraZeneca
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DV05 Interactive Graphs
Kriss Harris, SAS Specialists & Richann Watson, DataRich Consulting
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DV06 Building Interactive Web Apps – Experiences with R Shiny
Stephanie Fechtner, Bayer
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DV07 Using R Shiny to Create an Interactive Visualisation Patient Profile
Elva Chen & Brian Munneke, Corvus Pharmaceuticals
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Leadership & Innovation (LI)

LI01 The Importance of Sleep and How Best to Measure It
Neil Stanley
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LI02 The Impact of AI, RWE, Precision Medicine and Mobile Health Technology on Streamlined Clinical Trials
Stijn Rogiers & Olivier Bouchard, SAS Institute
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LI03 Janssen’s Journey Towards a Culture of Innovation
Sumesh Kalappurakal & Sangeeta Bhattacharya, Janssen Research & Development
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LI04 Leading a Migration Project
Pauline Mcbain, PPD
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LI05 Statistical Programming in the Future – Our Mindset, Data FAIRness and the Importance of Stakeholder Relationships (winner)
Christopher Ziegler, Roche
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Machine Learning (ML)

ML01 Using Image Recognition in Production Support
Thomas Dekelver, Business & Decision Life Sciences
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ML02 Sub-population Detection Using Graph-based Machine Learning
Sergey Glushakov & Kostiantyn Drach, Intego Group
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ML03 Symbolic Regression: Survival of the Best Fit
Hector Leitch, Veramed
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ML05 Do You Know What Your Model is Doing? A Look at How Human Bias Influences Machine Learning
Jim Box & Elena Snavely, SAS Institute
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ML06 Using R to Build Artificial Neural Networks in Medical Data
Thomas Wollseifen, Syneos Health
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ML07 Interpreting Black-box Machine Learning Models: Real-world Evidence Examples and Application
Jim Box, SAS Institute
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ML08 SMART RPA – Powered by Machine Learning
Charan Kumar Kuyyamudira Janardhana, Ephicacy
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ML09 AI-assisted Code Reviews (winner)
Igor Khorlo, Syneos Health
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Personnel Management (PM)

PM01 Assessing Your Pipeline. People Not Trials!
Jennifer Dootson, d-Wise
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PM02 Onboarding a Junior Statistical Programmer in 10 Weeks: My Story, from University to First Analysis Delivery
Pieter Coppens & Annelies Van Zeveren, SGS Life Sciences
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PM03 Line Management and Mentoring
Tom Ward, PPD
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PM04 Personnel Manager – Be the Owner of Checks and Balances
Preeti Ghatge, Accenture
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PM05 No Place Like Home: Managing Remote Programmers Remotely (winner)
Caroline Terrill, Cytel
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PM06 Mistakes Managers Make While Managing Data Scientists that You Will Want to Identify and Prevent
Jim Johnson, Independent
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PM07 Six Sigma DMEDI Methodology: Drive and Develop Your Team
Caroline Gray, CROS NT
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Poster Presentations (PP)

PP01 Efficiently Simulating Normally Distributed Data for Animation
Benjamin White, GlaxoSmithKline
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PP03 Challenges Involved with Using Legacy Clinical Trial Study Data During Integration
Adebola Opasanya, GlaxoSmithKline
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PP04 Novo Nordisk Implementation of Logically Skipped Items for the QS=Questionnaires Domain
Hanne Van Kints, Novo Nordisk
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PP05 Medical Device SDTM Domains: A Real Case
Alessia Sacco & Roberto Teli, LivaNova
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PP06 FAIR Data Standards in the GDSR (winner)
Huw Mason, Roche
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PP07 Stuck in a Rut? (winner)
Prakash Mistry & Jordan Bristow, PHASTAR
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PP08 Quality Control and Validation – More Than Just PROC COMPARE
Evgeny Starostin, Worldwide Clinical Trials
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PP09 Programming in the World of PK: Guidance for the Beginner
Paige Lewis, Veramed
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PP10 Preparing Big Data for Analysis
Thomas Ellebæk, Ferring Pharmaceuticals
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PP11 Macro-enabled Trial Design Domain Specification Template
Chintankumar Patel, Janssen Research & Development
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PP12 Speed Breaker, Traffic Signal and Toll Gates of a Highway Journey of a Sponsor–Vendor Relationship
Anik Chatterjee & Anusuiya Ghanghas, Novartis
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PP13 Seven Habits of Highly Effective (Validation Issue) Managers
Amy Garrett, Pinnacle 21
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PP14 Dynamic Footnotes – Be More Dynamic Than Your Statistician
Wilfried Esken, HMS Analytical Software
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PP15 Automating the blankcrf.pdf and Define-XML from Your Database Build
John Mcdade, Vivos Technology
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PP16 Linked Data URIs
Kerstin Forsberg, AstraZeneca & Johannes Ulander, S-Cubed
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PP18 PHUSE CDISC Implementation Primer Project Overview and Update
Beate Hientzsch, Independent & Nick De Donder, Business & Decision Life Sciences
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PP19 Janssen Autism Knowledge Engine (JAKE) System in Autism Spectrum Disorder
Sarah Bonneux, Janssen Research & Development
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PP20 Holon – What, Why and How
Catharina Dahlbo, Capish
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PP21 ADaM Programming Made Easy – Common ADaM Templates and an SAS Macro Library
Niels-Kristian Kjøller, Novo Nordisk
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PP22 Overlays Data Capture Architecture (ODCA): Providing a Standardised Global Solution for Data Capture
Paul Knowles, Dativa
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PP23 Modern Analytics within an Open-source SCE – Are We Still Dreaming?
Sam Warden & Ali Dootson, d-Wise
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PP24 Data Anonymisation & Risk Assessment – Process Map and Automation Efforts
Lukasz Kniola, Biogen
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PP25 An Algorithm for Prioritising Time- constrained Clinical Trial Activities 
Andy Richardson , ZENETAR
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PP27 Vaccines Impact: Benefits for Human Health
Mickael Borne, 4Clinics
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Professionsal Development (PD)

PD01 Putting Ourselves Under the Microscope. Exploring Professional Identity and Wellbeing: Impacts for Career Development
Helen Smith & Sarah Crozier, University of Manchester
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PD02 10 Useful Skills You May Have Learned through Being a Programmer – Other than Programming
Paul Grimsey, Roche
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PD03 Leaders – Wanted
Detlef Nehrdich, Waife & Associates
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PD04 The Importance of Feedback (winner)
Donald Paterson, Janssen Research & Development
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PD05 Career (and Life) Improvements Through Self-quantifying Biohacking Techniques
Sascha Ahrweiler, Bayer
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Real-world Evidence (RW)

RW01 Utilising RWD and RWE: An Introduction to Core Concepts and Requirements
Christopher Hurley & Aditya Gadiko, MMS
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RW02 The Promise of Wearable Technology in Clinical Trials: A Proof of Concept to Deliver it?
Jennifer Bradford, PHASTAR
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RW03 Early Experiences Using SDTM to Organise Clinical Data Collected Using a Physical Activity Tracker (winner)
Martin Gram & Gianluca Mortari, Novo Nordisk
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RW04 Use of FHIR in Clinical Research: From Electronic Medical Records to Analysis
Jeff Abolafia, Rho
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RW05 Using Natural Language Processing to Transform Real-world Data
Jane Reed, Linguamatics & Thierry Breyette, Novo Nordisk
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RW06 Deriving Line of Therapy: An Algorithmic Approach in a Real-world Oncology Database
Matthew Thompson, IQVIA
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RW07 Analysing Real-world Data – Case Study
Anik Chatterjee & Sibasish Saha, Novartis
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Scripts & Macros (SM)

SM01 R or Python? Dilemma, Dilemma... (winner) 
Nicolas Dupuis, d-Wise & Elsa Lozachmeur, Idorsia
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SM02 Validate the Validated: A Python Tool for Study Leads to Review Clinical Outputs
Varaprasad Ilapogu & Janet Li, Pfizer
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SM03 How to Use VBA for CRT: Automating the P21 Community Master Spec
Matt Metherell, PHASTAR
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SM04 SAS Macro Quoting – A Look Behind the Scenes
Tim Lepp, Bayer
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SM05 An Efficient Way to Combine RTF Files and Create Multi-level Bookmarks and a Hyperlinked TOC
Lee Armishaw & Lugang Xie, Janssen Research & Development
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SM06 Adapting the SAS Enterprise Guide Log Summary to Check Your LOG for You
Lawrence Heaton-Wright, IQVIA
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SM07 Automating Validation of Statistical Reports – A Real Case Study
Neel Patel & Deepak Kumar, Novartis
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Software Demonstrations (SD)

SD01 Formedix On: Advanced Metadata Management and Data Conversion (winner)
Kevin Burges, Formedix
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SD02 R You Ready for Simulo: A User-friendly Clinical Trial Simulator
Nicolas Luyckx & Quentin Leirens, SGS
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SD03 Automated RTF Table Translation – An Illustrated Approach
Amit Bhaniani & Qian Wang, MSD
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SD04 Embrace Real-world Data and Enhance Your Analytics Approaches with SAS’ Open Platform
Stijn Rogiers & Sherrine Eid, SAS Institute
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SD05 Management and Enforcement of Custom Standards and Terminologies with Pinnacle 21 Enterprise
Brad Moran, Pinnacle 21
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SD06 Selection in Action
Peter Tormay, Capish
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SD07 Oracle Analytics Cloud
Mike Collinson, Oracle Health Sciences
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SD08 Exploring How the Nurocor MDR Can Bring Order to Your Metadata
Barrie Nelson & Roopa Kandukuri, Nurocor
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SD09 Analysing Clinical Trials Data with R
Adrian Waddell, Roche
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SD10 Clarity Stack® Clinical Technology – A Holistic View of Clinical Trial Operational Status and Patient Safety Data
Dirk Spruck, Clinipace
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Standards Implementation (SI)

SI01 How Will You Use CDISC Library?
Sally Cassells, CDISC
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SI02 Implementing the CDISC Library API in Software Applications: First Experiences
Jozef Aerts, XML4Pharma
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SI03 Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts
David Iberson-Hurst, S-Cubed
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SI04 Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit
Andrew Bullivant, PHASTAR
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SI05 Fake it Till You Make it with Global SDTM Laboratory Submissions
Éanna Kiely, ClinBuild
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SI06 End-to-end SDTM Automation: A Metadata-centric Approach (winner)
Roman Radelicki, SGS Life Sciences
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SI07 How to Use SUPPQUAL for Specifying Natural Key Variables in Define-XML?
Sergiy Sirichenko, Pinnacle 21
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SI08 Making the Data Mapping Process Easier and Smarter with SAS and R
Andrii Artemchuk, Intego Group
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SI09 Choosing the Right Path to Follow When Integrating ADaM
Magalie Gallet & Laura Phelan, Cytel
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SI10 ADSL – Friend or Foe?
Jørgen Mangor Iversen, LEO Pharma
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Submissions & Agencies (SA)

SA01 Development of the Standard BIMO Process to Create the Clinsite Dataset
Hilde Delanghe, Janssen Research & Development
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SA02 Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective (winner)
Delphine Kerzerho, Novartis & Hiren Naygandhi, Roche
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SA03 ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements
Marianne Caramés, Novo Nordisk
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SA04 Processing Big Data from Multiple Sources
Berber Snoeijer, ClinLine & Vijay Pasapula, Gilead Sciences
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SA05 How Metadata Can Help Drive the Creation of Tables, Figures and Listings
Judith Goud & Stephen Castellano, Nurocor
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SA06 Integrated Data and Document Anonymisation for Efficient Data Sharing
Ali Dootson & Cathal Gallagher, d-Wise
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SA07 Navigating FDA Requirements: ISS/ISE Build Strategies
Priyank Patel, Accenture
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Trends & Technology (TT)

TT01 Building a F.A.I.R. Foundation for Pharma: The PHUSE GoingTWLD Project
Tim Williams, UCB & Armando Oliva, Semantica
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TT02 All About Versioning – An Intro into Distributed Version Control
Mark Bynens & Sumesh Kalappurakal, Janssen Research & Development
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TT03 Our Industry: Technology-driven or Driven by Technology?
Faheeza Rangunwala, GCE Solutions
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TT04 Deconstructing SDTM – Starting Again (winner)
Johannes Ulander, S-Cubed
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TT05 An Introduction to Python: The SAS Programmer's Guide
Bradley Harris, GlaxoSmithKline
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TT06 Linked Data: Introduction and Deep Dive
Nicolas Dupuis, d-Wise
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TT07 Deep Sequencing
Koen Ven & Chantal Kersten, Janssen Research & Development
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TT08 Building Integrated Clinical Ecosystems
Stijn Rogiers, SAS Institute
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TT09 Back to the Studio: Why SAS Studio Merges the Past, Present and Future of Programming Clients
Paul Shannon, Amadeus Software
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TT10 Overcoming Hurdles in Clinical Programming Project Management Using Microsoft Teams
Yan Wu & Sofie Cambré, Janssen Research & Development
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