Annual Conference 2015

PHUSE 2015 was held at the InterContinental Wien in Vienna, Austria from the 11th to 14th October and was chaired by Chris Price (Roche). The Conference was a huge success with 500 delegates attending.

Each day started in the best possible way with an inspiring keynote speaker. On Monday Alex Flynn opened the Conference with an emotional and stirring speech about his struggle against personal adversity following his diagnosis with Parkinson’s disease. The challenge he set himself to cover 10 million metres (equivalent to crossing the Atlantic) to raise money for Parkinson’s research illustrated how much it is possible to achieve when you truly put your mind to it. Tuesday started with John Sall introducing some graphical and statistical techniques that can be used to effectively and efficiently interpret big data. Finally on Wednesday, Simon Weston brought tears to the eyes of many in the room with his extraordinary personal story. Simon’s overwhelming positive outlook on life and his message you remain responsible for what you can achieve regardless of the challenges you face was inspirational to all those who heard him speak.

The backbone of the conference was the high quality presentations on topics relevant to our industry and the informative hands-on workshops and discussion clubs. All the papers and presentations from the 14 streams will be available on the website soon.

We would like to thank all our sponsors, exhibitors and attendees for supporting us and making the conference such a huge success.

2015 Papers / Presentations

Best in Stream Winners are highlighted in bold text.

Applications and Software Development

AD01: Data-centric System Development Life Cycle for Automated Clinical Data Development Systems
Kevin Lee, MarkLogic
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AD02: Close operation between Developers and End-Users is Vital to Deployment of CDISC Standard Software
Donald Benoot, SGS Life Sciences Services
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AD03: Constructing a Simple Data Repository
Magnus Mengelbier, Limelogic
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AD04: Is R the Right Tool for Me?
Peter Bewerunge, accantec consulting
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WINNER AD05: Statistical Analysis Reporting Tool (StART), From Concept to Table Production 
David Hartman, UCB
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AD06: The Data Listing Facility: Data is Just a Few Clicks Away
Luigi De Vittorio, OCS Consulting
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AD07: Automated Generation of Program Templates with Metadata based Specification Documents for Integrated Analysis
Thomas Wollseifen, InVentiv Health Clinical
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AD08: An API for Your Data
David Brennan, Independent Consultant
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Coder's Corner

CC01: ODS DOCUMENT: A Practical Example
Ruurd Bennink, OCS Consulting
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CC02: Generating Multiple Parameter Reports into Single Reports Using %Do Loop and CALL SYMPUTX
Krishna Gohil, InVentiv Health Clinical
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WINNER CC03: Fun with Formats
Sarah Berenbrinck, Independent
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CC04: Automating Production of the blankcrf.pdf in a CRO Environment
Jonathan North, S-cubed Biometrics
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CC05: Dynamic, Powerful, User-friendly SQL Joins Made Easy with %VARLIST, a Generic SAS® Macro Function
Jean-Michel Bodart, Business & Decision Life Sciences
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CC06: SQL by Example: A Comparative Introduction to PROC SQL
Jeanina Worden, Santen
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CC07: Slim Down Your Data
Mickael Borne, 4Clinics
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CC08: The Ampersand (&) Challenge: Single, Double or More?
Amar Nayakj, Sequensys
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CDISC and Industry Standards

CD01: Introduction to CDISC BRIDG
Joerg Dillert, Oracle
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CD02: Are Your Ready for SEND?
Roman Radelicki, SGS Life Sciences Services
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CD03: Therapeutic Area Standards and their Impact on Current SDTM Implementations
Johannes Ulander & Niels Both, S-cubed
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WINNER CD04: Access to CDISC SHARE Metadata: A La Cate, Prix Fixe or Table d'Horte?
Ken Stoltzfus, Accenture
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CD05: Managing Data Standards Libraries Compliance (to CDISC)
Deborah Paletta, Business & Decision Life Sciences
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CD06: A Model for Reviewing the Operational Implementation of the CDISC Standards
Andy Richardson, d-Wise
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CD07: Data Governance - Keeping Control through a Well-defined Changes Request Process
Gavin Winpenny, Business & Decision Life Sciences
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CD08: Improving CDISC SDTM Data Quality & Compliance Right from the Beginning
Bharat Chaudhary & Padamsimh Balekundri, Cytel
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CD09: Managing ADaM Metadata
Ann Fitzherbert & Khilit Shah, GlaxoSmithKline
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CD10: ADaM - Our Experience
Rob Wartenhorst, GlaxoSmithKline
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CD11: Dataset-XML - A New CDISC Standard for Data Exchange
Julie Maddox & Lex Jansen, SAS Institute
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CD12: Results-level Metadata: What, How and Why
Frank Dilorio, CodeCrafters & Jeff Abolafia, Rho
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CD13: ADaM Reviewer's Guide - Interpretation and Implementation
Steve Griffiths, GlaxoSmithKlilne
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Coding Solutions

CS01: Merging Supplemental Data into Parent Domains
Dirk van Krunckelsven, Merck
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CS02: SAS Macros - Useful Bits and Pieces
Lawrence Heaton-Wright, Quintiles
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CS03: MULTILABEL Option - Valuable Addition to PROC FORMAT
(Frequency Analysis with MULTILABEL Formats)
Anna Amosova, Experis
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CS04: Creating Native Excel Workbooks in SAS in a Non-Windows Systems without SAS/ACCESS
Edwin van Stein, Astellas Pharma Global Development
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CS05: Hands-on Data Mining, Digging up clinicaltrials.gov Data with SAS 9
Mahdi About, Novartis
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WINNER CS06: Detecting Irregularities in Electronic Patient-reported Data
John van Bemmelen, OCS Consulting
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CS07: Create Interactive Web Graphics Out of your SAS or R Data Sets
Patrick Warnat, HMS Analytical Software
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CS08: Enhance and Enrich your Plots Using Graph Template Language (GTL)
Mathias Lebreton, Novartis
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Data Handling

DH01: PHUSE De-identification Working Group: Providing identification Standards to CDISC Data Models
Jean-Marc Ferran, Qualiance, Khaled El Eman, Privacy Analytics & Sarah Nolan, University of Liverpool
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DH02: Metadata-driven- Yet Another Cliché in our Industry
Chris Decker & Ian Fleming, d-Wise
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DH03: Data Encoding:All Characters for All Countries
Donna Dutton, SAS Institute
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DH04: E2E Data Standards: The Need for a New Generation of Metadata Repositories
Isabelle de Zegher, PAREXEL Informatics
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DH05: "CONNECT and CREATE" - Connect Standards and Enable Protocol Authoring
Abi Velurethu & Susanne Pangritz, Bayer Healthcare
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DH06: How a Clinical Data Repository can Support Pharmacovigilance
Pantaleo Nacci, GlaxoSmithKline Vaccines
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WINNER DH07: Study Anonymisation: From Request to Delivery
Kelly Mewes & Sai Jandhyala, Roche
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DH08: "CodEX" - When Excel Meets SAS to Code Clinical Data
Stéphane Chollet & Cathy Scoupe, Keyrus Biopharma
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DH09: The Rocky Road to Data Transparency
Rafi Rahi, Poritosh Modak & Shafi Chowdhury, Shafi Consultancy
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Industry Starters

WINNER IS01: WPP, Worst Programming Practice - Real-life Pittfalls in Everyday Clinical Programming: Why and How
Hannes Engberg Raeder, PRA Health Sciences & Rowland Hale, InVentiv Health Clinical
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IS02: Introduction to GPP with Hints and Tips to Make them Second Nature
Alexandra Marquat, Boehringer Ingelheim, Shafi Chowdhury, Shafi Consultancy & Beate Hientzsch, Accovion

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IS03: The Evolution of Computing in Clinical Research: Past, Present and Future
Mark Weadon, SAS Institute
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IS04: A Lot More than Patient Data
Nigel Montgomery, Novartis & Satyapal Gudla, Novartis Healthcare
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IS05: If I Had a Hammer
Diana Stuart, Veramed
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IS06: The Highs, Lows and Lessons of a First-Time Study Lead
Bethan Thomas, PRA Health Sciences
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IS07: SAS in UNIX/Linuc - From the Terminal to GUI
Lovemore Gakava & Sanjay Kannan, Synergy Clinical
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IS08: Don't be Afraid of PROC REPORT - A Step-by-Step Guide
Nicola Tambascia & Konstanze Morgenroth, Accovion
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Management (No Papers available)

Session 1: Change Management - Making Change Stick
Celine Tendero, Novartis
Samantha Wardcen, d-Wise

Session 2: CRO Collaboration

Asa Carlsheimer, Ferring Pharmaceuticals
Ed Jones, F. Hoffman-La Roche and Genentech
Louise Webber, Merck
Darren Weston, Novartis

Session 3: Future Standardisation and Optimisation

Mike Barton, Chief Constable, Durham Constabulary

Session 4: Expert Panel

Lynn Clipston, PPD
Mark Matthews, GCE Solutions
Gary Kennedy, Boehringer Ingelheim
James Gallagher, Novartis
Peter van Reusel, Business & Decision Life Sciences

Professional Development & Training

PD01: FDA Review Principles Applied to CRO Oversight
Sascha Ahrweiler, Ankur Mathur & Grace Ignacio, Bayer Pharma
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PD02: Similarities and Differences in Statistical Programming Among CROs and Pharmaceutical Industries
Mark Matthews, GCE Solutions
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WINNER PD03: The AQSCI Method Behind CRO Evaluation and Application to Pharmaceutical Company Needs
Roy Ward, PPD & James Gallagher, Novartis
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PD04: Data Scientist - What It Is (Not)
Michaela Jahn, Roche
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PD05: Working as a Data Scientist with Real-world Clinical Data
Berber Snoeijer, PHARMO
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PD06: Analysing the Role of a Lead Programmer
Ester Schoeman, Biogen
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PD07: Best Practices in Managing a Global SAS Programming Team
Yi Zhang, GlaxoSmithKline
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PD08: Unleashing the Analyst: Establishing a Department of Dynamic Real-world Data Science (RWD-S) Analysts who are able to Partner, Influence and Drive the Generation of Real-world Evidence
Ryan Copping & Rob Walls, Roche
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PD09: Industry Standard for Good Programming Practices: Benefits and Implementation
Mark Foxwell, PRA Health Sciences, Kate Peacock, Quintiles & Beate Hientzsch, Accovio
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PD10: Work Harder or Work Smarter?
Colin Brown, Hearthought Enterprises
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PD11: The Rewarding (and Rocky) Road from SAS Applications Programmer to SAS Software Developer
Jeff Abolafia, Rho & Carrie Dundas-Lucca, Zencos Consulting
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Poster Presentations

PP01: A Modularised Approach to the Development of a Data Science Tool
Guiseppe Di Monaco, UCB
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PP03: Exploring Ways to Render SAS Data Sets thought the Web
Pascal Verrecchia, SOKARIS Informatique
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PP05: Understanding SE, TA TE Domains
Jacques Lanoue, Novartis Pharmaceuticals
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PP06: Finding Out about Findings About
Carolina Clark-Steel, Sunshine Programming
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PP07: EPOCH in Reverse
Ann Croft, Leo Pharma
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PP08: Standardised Reporting Using ADaM (STREAM Model)
Ankur Chakraborty, TCS
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PP09: Errors Beyond Open CDISC Validator
Gayatri Karkera, Ushma KUmar & Nehan Mohan, InVentiv Health Clinical
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PP10: Only Time Will Tell? - Identification of Predictors for Binary Outcomes in Longitudinal Designs
Knut Mueller, UCB
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PP11: Preparing and Utilising Claims and Electronic Medical Records Data for Clinical Research
Laurie Rose, SAS Institute
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PP12: Building a Strategic Focus on Data... Transitioning to a New Paradigm
Allison Brailey, Joanna Koft & Lynn Difinizio, Biogen
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JOINT WINNER PP13: From Data Management to Statistical Programming: A Real-Life Change
Benjamin Lerbour, Novartis
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PP14: The SAS Clinical Standards Toolkit - A Helpful Tool for Creating CDISC SDTM-compliant Study Data
Nicolai Haag, HMS Analytical Software
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PP15: Ensuring Data Quality in Outsourced Studies - The Role of the Data Scientist
Sarah Malbon & Vikki Horton, Roche
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PP16: Steps and Slides of Implementing Global Standards
Terek Peterson & Karin LaPann, Chiltern
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PP17: AstraZeneca Clinical Trial Transparency and External Sharing of Individual Patient-level Data
Natalie Andrews, AstraZeneca
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PP18: The Expanding Role of the Statistical Programmer
Punitha Philip & Minola Ilica, Cmed
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PP19: Ensuring the Quality of your Data in Respiratory Trials: DM from a Statistical Standpoint
Diana Stuart & Abigail Fuller, Veramed
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JOINT WINNER PP20: Exploratory Analysis vs Regulatory Reporting
Mijanur Rahman, Roche
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PP21: Blinding the Unblinded
Angelo Tinazzi & Dean Shults, Cytel
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P22: Change in Prevalence and Distribution of DM Type 1 and Type 11 Over Time in the Netherlands
Berber Snoeijer & Jetty Overbeek, PHARMO Institute
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PP23: A StAR is Born: AstraZeneca/Quintiles Partnering for Success 
Alison Dobson, AstraZeneca & Alex Brink, Quintiles
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PP24: Independent Double Programming - Are We Doing the Right Thing?
Beate Hientszch, Accovion
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PP25: Good Programming Practice at a Glance
Mark Foxwell, PRA Health Sciences & Beate Hientszch, Accovion
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PP26: Using SAS Graphics to Help with Decision-making in Early Clinical Development
Sinela Hadzovic, AstraZeneca R&D
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PP27: PASS and the Programmer
Rachel Bowman, Amgen
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PP29: Developing Annotated CRFs: SAS, Excel and Patience as your Friends
Ilias Pyrnokokis, OCS Consulting
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PP30: Data De-identification: Balancing Patient Privacy, Data Utility and Good Programming Practices
Jon Davidson & David Handelsman, d-Wise
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PP31: Flexible Solutions for Insight and Data-driven Innovation
Catharina Dahblo, Capish Nordic
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Regulatory (No Papers or Presentations available)

Fergus Sweeney, EMA
Lilliam Rosario, FDA
Yuki Ando, PMDA

Software Demonstrations

SD01: Efficient Data Reviews and Quality in Clinical Trials Using CDISC Data Standards
Válerie Nedbal, SAS Institute
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SD02: Implementation of an in-house Data QC Tool to Streamline SDTM Production Data
Karlien Knevels, SGS Life Sciences Services
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SD03: Driving Quality into Clinical Trials
Erik Doffagne, CluePoints
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SD04: Empowering Users with Automated Data Conformance Solution Utilities
Michael Whitworth & Jonathan Burr, Accenture
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SD05: Finding your Data Faster by Combing Content and Metadata Search
Jórn Billow, Entimo
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SD06: De-Id: 'The What' and 'The How' of de-identifying your Clinical Trial Data
Gavin Winpenny & Stephen Bamford, Business & Decision Life Sciences
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SD07: SAS Software Demonstration - SAS In-Memory Visual Analytics
Andy Bayliss, SAS Institute
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Statistics and Pharmacokinetics

SP01: Programming Strategically for PK/PD Data
Grace Lu, AstraZenecaDownload Presentation

WINNER SP02: Adjusting Long-term Efficacy Estimates when Patients Cross Over to Experimental Treatment
Sabine Lauer, Dr. Lauer Research
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SP03: How to Reduce Bias in the Estimates of Count Data Regression
Ashwini Joshi & Sumit Singh, Cytel
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SP04: Establish the Maximum Tolerated Dose in Phase 1 Trials Using the 3+3 Method
Anup Pillai, Cytel
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SP05: Facing Your Fear of the Unknown- Handling Missing Data
Amanda Reilly, ICON
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SP06: A Simple and Novel Approach for the Assessment of Clinical Pharmacokinetics (Fast-track PK Analysis)
Ramanatha Saralaya & Nand Kishore Rawat, Cytel
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SP07: Bias Reduction in Observational Cohort Studies - Obtaining Matched Cohorts Using Propensity Scores
Shelley Fordred, Savvy Stats, Victor Kiri, FV & JK Consulting and Knut Mueller, UCB
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Technical Solutions

TS01: Metadata Snapshots: How SAS Drug Development API Macros Can Help
Melissa Martinez SAS Institute
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TS02: Concept and Implementation of an Efficient Version Control System for SAS® Programs in Clinical Development
Dirk Spruck & Matthias Post, AccovionDownload Presentation

TS03: Getting the Most Out of Keys - Using Hash Components to Select, Subset or Summarise
Pamela Giese, inVentiv Health Clinical
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TS04: EmpoweR your Application with R!
Sudipta Basu & Pravin Holkar, Cytelk
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WINNER TS05: Graphics in R - A Shiny Way to Program
Carolyn Nixon, Roche
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TS06: Unleash the Power of Adobe Acrobat® using JavaScript
Oliver Wirtz, Bayer Pharma
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TS07: Innovative Approach to Building an Adaptive Trial Design in Medidata Rave
Joris De Bondt & Tine Seeuws, SGS Life Sciences Services
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TS08: The Automated Metadata-driven Table Generation Process (TFLGen) at Amgen
Neil Lyon, Amgen
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TS09: Clinical Data to Information: Quick, Standardised and Validated with Knowledge of PROC FCMP
Cathal Gallagher, d-Wise
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TS10: SAS® Enterprise Guide or SAS® Studio: Which is Best for You?
Philip Holland, Holland Numerics
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Trends and Technology

TT01: A Strategy to Get Data Governance and Analytical Agility Combined
Peter Grolimund, Teradata
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WINNER TT02: How to Create a Mobile App: Walkthrough Example Including SAS Output
Katja Glass, Bayer Pharma
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TT03: Using Graphics to Present the Study Result as a Story
Shafi Chowdhury & Rajwanur Rahmann, Shafi Consultancy
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TT04: From Data to Knowledge: Semantics and Implementations
Judith Goud & Julie Smiley, Amgen
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TT05: Data Visualisation: The New Era of Revolution in the Pharmaceutical Industry
Saroj Kumar Jena, GCE Solutions & Vipin Arora, Eli Lilly and Company
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TT06: Understanding Trial Design Using Visualisation
Maria Benjegard & Kerstin Forsberg, AstraZeneca R&D
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TT07: 'Dude. Where's My Graph?' RDF Data Cubes for Clinical Trial Data
Tim Williams, UCB & Marc Andersen, StatGroup
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TT08: Future Drug Applications with No Tables, Listings and Graphs?
Kirsten Langendorf, SAS Institute
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TT09: CDISC Standards and the Semantic Web
David Iberson-Hurst, Assero
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TT10: The Technology of Context
Ian Fleming & John Leveille, d-Wise
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