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PhUSE Conference 2011

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Conference 2011

PhUSE 2011 was the seventh annual conference was held at the Hilton Metropole Hotel in Brighton on the 9th to 12th October and was chaired by Yvonne Moores (Quanticate).


2011 Papers / Presentations

Best paper winners are highlighted in bold text and will be featured in the next edition of Pharmaceutical Programming.

Applications and Software Development

AD01: Development of SAS Standard Macro Systems
Katja Glass, Bayer Pharma AG
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AD02: Adoption of Agile in Medidata
Tony Hewer and Andrew Smith, Medidata  Solutions Inc
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AD03: Translating eClinical Data - The Art and Science of Data
Nikki Dowlman, Perceptive Informatics
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AD04: Unit Testing as a Cornerstone of SAS® Application Development
Dante Di Tommaso, F. Hoffmann-La Roche
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AD05: Writing standard programs your people will use and love!
Jean-Marc Ferran, Qualiance
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AD06: Sharing SAS programs between PC Server and SAS Drug Development
Magnus Mengelbier, Limelogic Limited
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AD07: Migration + upgrade = happy users but how many days downtime?
Nigel Montgomery, Novartis and David Garbutt, BIOP
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AD08: Analysis and Reporting Toolset (A&RT): Lessons learned on how to develop a system with an external partner
David Smith, AstraZeneca
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AD09: Building Block macro principle for Standard Program Library Design
Francis Dsa, Novo Nordisk A/S
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AD10: A Modern Software Design Principle Applied to SAS Macro Programming: The Inversion of Control Concept
Patrick Warnat, HMS Analytical Software GmbH
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Coder's Corner

CC01: Data cleaning and spotting outliers with UNIVARIATE
Michael Auld, Ampersoft Ltd
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CC02: Writing Parallel Processing Compatible Engines Using OpenMP
Aniruddha Deshmukh, Cytel
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CC03: Using Microsoft Excel to Write SAS Code
Andrew Boyd, Quanticate
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CC04: SAS Data Set Utility with Excel Output
Rob Horton, Quanticate
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CC05: Missing Values in SAS
Magnus Mengelbier, Limelogic Limited
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CC06: Use of ODS tagsets.excelxp to create Excel type files
Douglas Staddon, Cmed Ltd
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CC07: Seven sharp surgery tips for Clinical Programmers
Rohit Banga and David Garbutt, Biometrical Practice, BIOP AG
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CC08: Learning to love the SAS LAG function
Herman Ament and Paul Vervuren, MSD - Netherlands
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CDISC & Industry Standards

CD01: ADaM Validation and Integrity Checks
Louise Cross, ICON Clinical Research
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CD02: SDTM Implementation Guide - Clear as Mud: Strategies for Developing Consistent Company Standards
Brian Mabe, UCB BioSciences Inc
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CD03: Three Unique Case Studies - On the Trail of the Holy Grail of SDTM Implementation
Kenneth Stoltzfus, Octagon Research Solutions
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CD04: Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies - an ICON Approach
Jennie McGuirk and Steven Thacker, ICON Clinical Research
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CD05: SDTM Domain QS: Challenges and Pitfalls - an Interpretation Guide to the Implementation Guide
Knut Mueller, UCB BioSciences
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CD06: Using the SAS® Clinical Standards Toolkit to work with the CDISC ODM model
Lex Jansen, SAS Institute Inc
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CD07: SAS Drug Development as a platform governing data standards specification and clinical data exchange
Mark Lambrecht, SAS and Peter Van Reusel, Business & Decision Life Sciences
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CD08: Tracing data elements through a standard data flow
Alistair Dootson, Dootsonic
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CD09: Defining the Governance and Process of Implementing ADaM across an Organization
Chris Decker, d-Wise Technologies
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CD10: 
Creating ADaM Friendly Analysis Data from SDTM Using Meta Data
Erik Brun and Rico Schiller, H. Lundbeck A/S
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CD11: ADaM on a diet: preventing wide and heavy analysis datasets
Dirk Van Krunckelsven, Merck Serono International S.A
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Coding Solutions

CS01: Effective SAS greplay'ing and how to avoid stretching
David Mottershead, Quanticate
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CS02: A SAS macro to check SDTM domains against controlled terminology
Guido Wendland, UCB Biosciences GmbH
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CS03: Many too many, too many performance tests
Christopher Baumer, Biometrical Practice BIOP
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CS04: Managing data issues identified during programming
Shafi Chowdhury and Aminual Islam, Shafi Consultancy Limited
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CS05: SAS Goes Spreadsheet
Raimund Strob, Boehringer Ingelheim Pharma GmbH & Co. KG
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CS06: Why Should You Be Using the New SG (Statistical Graphics) Procedures in SAS® 9.2?
Philip Holland, Holland Numerics Ltd
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CS07: Calling R Functions from SAS
Peter Bewerunge, HMS Analytical Software
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Data Handling

DH01: Don't Bring a Spreadsheet to a Database Fight: Case for Microsoft Access
Ryan Burns, Rho, Inc
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DH02: The Evolution of Coding Technology
Richard Davies, Oracle
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DH03: Remapping of Codes (and of course Decodes) in Analysis Data Sets for Electronic Submissions
Joerg Guettner, Bayer Pharma AG
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DH04: An Approach to Standard Programming in a Central Data Repository
Robert Ellison, ICON Clinical Research
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DH05: Comparing dataset metadata
Jim Groeneveld, OCS Consulting
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DH06: Research Project on Metadata Extraction, Exploration and Pooling: Challenges and Achievements
Ronald Steinhau and Dimitri Kutsenko, Entimo AG
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DH07: Much ADaM about Nothing - a PROC Away in a Day
Endri Endri and Rowland Hale i3
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Industry Starters

IS01: Training Statistical Programmers on SAP review skills
Sascha Ahrweiler, UCB BioSciences, GmbH
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IS02: Effecting Efficiency Effortlessly
Daniel Carden, Quanticate
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IS03: New Starter Models for Pharmaceutical companies and Clinical Research Organisations (CROs)
Lovemore Gakava, Roche
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IS04: How to create a custom style
Sonia Extremera, Antonio Nieto and Javier Gómez, PharaMar
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IS05: A Career in the Pharmaceutical Industry
James McDermott, Ab Tartarus
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IS06: Using R to Validate Results of Other Programming Environments
Nikhil Abhyankar and Vidyagouri Prayag, Cytel
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IS07: A is for Acronym!
Alex Hughes, Roche
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Management

MA01: How personalities and motivations impact IT projects
David Smith, SAS Institute
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MA02: State of the union: what does the future hold for statistical programming in Europe
Leo Valmas, Quintiles
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MA03: Conference 2.0, moving from attendance to collaboration
Benjamin Szilagyi, Roche
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MA04: Sponsor-FSP collaboration: an adaptive design for enduring success
Manjusha Gode, Cytel Statistical Software & Services Pvt. Ltd., and Claudia Hammer, Merck Serono
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MA05: The Nycomed outsourcing model - Data standardisation experience after three years
Berthold Traub, Nycomed GmbH
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MA06:The Future for the Western Statistics and Programming Communities in the Face of Globalisation?
Kevin Kane, Phastar
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Professional Development & Training

PD01: Challengers Facing the Programmer in Observational Research
Laurence Carpenter, Amgen
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PD02: Managing Telecommuters and Global Virtual Teams
Syamala Schoemperlen, ICON Clinical Research
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PD03: Programming for Early and Late Phase - really that different?
Katherine Macey, Roche Products Limited
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PD04: Introduction of Pharmaco-economics for non-health economists
Elhem Sbaa, Keyrus Biopharma
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PD05: Collaboration versus conflict: building successful working relationships
Diana Stuart, Cmed
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PD06: What makes a strong programming team?
Beate Hientzsch, Accovion GmbH
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PD07: How do we ensure the programmer we have today will meet the business needs of tomorrow?
Christine Leigh and Karen Rowe, Roche
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PD08: Critical Path Learning - How to Develop Top Level SAS Programmers
Paolo Morelli, CROS NT
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Poster Presentations

PP01: Managing a team within the CRO industry
Julie Oates, Quanticate
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PP02:Define Your Own SAS® Command Line Commands
Duong Tran, Tranz Ltd
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PP03:Use Your Favourite Program Editor
Duong Tran, Tranz Ltd
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PP04: Stacking Rich Text Format (RTF)  %SRiT
Duong Tran, Tranz Ltd
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PP05: Rapidly Retrieve Clinical Information across immense Data Sources: Introducing Reveal paper
John Leveille and Chris Decker, d-Wise Technologies, Inc
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PP06: JMP Clinical for the Exploration of Legacy Vaccine Trials
Robert Eric Huisden, OCS Biometric Support

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PP07: A simple interface for defining, programming and managing SAS edit checks
Virginie Freytag and Michel Toussaint, Clin Data Management
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PP08: Queries management: Interfacing SAS with in-house EDC application
Virginie Freytag and Michel Toussaint, Clin Data Management
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PP09:Learning from critical values - adverse event identification and classification
Milena Balcerzak, Quanticate
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PP10: Using Microsoft Excel to write SAS code
Andrew Boyd, Quanticate
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PP11: Chernoff face graphs as an efficient way of creating comprehensive Patient Profiles in SAS®
Adam Amborski, Quanticate
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PP12: Numeric precision and representation issues.  Why 4.8 - 4.6 is not always equal to 0.2.
Nicola Tambascia, Accovion
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PP13: Rebuilding define.pdf by reading Word and XFDF files
David Garbutt, BIOP AG
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PP14: An Animated Guide: A program to read information in SAS headers and produce reports for programming
Russell Lavery, Independent Contractor
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PP15:Extension of the Six Steps Approach: How to go from an SDTM finding domain to an ADaM-compliant AD
Carl Herremans and Qian Wang, Merck Sharpe & Dohme (Europe)
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PP16: Modifying Results of proc glm with proc template
Catalina Mejia Herrera, Bayer healthcare Pharmaceuiticals and Volker Harm, Bayer Pharma AG
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PP18: Simple Version Control of SAS Programs and SAS Data Sets
Magnus Mengelbier, Limelogic Limited
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Regulatory

RG01: Modular Programming - Some Lessons Learned and Benefits Gained
Ross Farrugia, Roche Products Limited
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RG02: Preparing an eSubmission based on multiple trials, some of which are ongoing- challenges for statistical programmers
Asa Carlsheimer, Ferring Pharmaceuticals A/S
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RG03: FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards
Peter Van Reusel and Tina Apers, Business & Decision Life Sciences

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RG04: Understanding NDA/BLA Clinical Data Submission
Dirk Spruck, Accovion
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RG05: Validation Discussion Group
Alison McDonald and Rob Horton, Quanticate and Dirk Spruck, Accovion


Software Demonstrations

SD01: Managing standards: Impact analysis in a metadata driven standards library
Dimitri Kutsenko, Entimp AG
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SD02: Study Composer: a CRF design tool enabling the re-use of CDISC define.xml metadata
Philippe Verplancke, XClinical GmbH
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SD03: The Evolution of Coding Technology - Demonstration
Richard Davies, Oracle
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SD04: Architect - A Platform for Design and Analysis Software for Clinical Trials
Shashank Maratkar and Aniruddha Deshmukh, Cytel Statistical Software & Services Pvt. Ltd
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SD05: Visualization of Time Windows linked to Patient Profiles in Clinical Trials
Valerie Nedbal and Geoffrey Mann, SAS Institute
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SD06: Access Control Execution Systems (ACES)
Shailesh Kulthe, Eric Silva and Venkitachalam Chandran, Cytel Statistical Software & Services Pvt. Ltd
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SD07: CYA with JMP - reloaded
David Garbutt, BIOP AG
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SD08: SAS Data Management Studio
David Smith, SAS Institute
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SD09: "Overnight" Conversion to SDTM Datasets - Ready for SDTM Submission
Niels Mathiesen, Mathiesen & Mathiesen
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SD10:ClinXPORT a software to streamline the analysis and reporting of clinical trials with SAS
Juline Vanwinsberghe, Francois Vandenhende and Philippe Remusat, ClinBAY
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SD11: SAS Clinical Data Integration
Bill Gibson, SAS
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Statistics & Pharmacokinetics

SP01: Estimation of relative potency in a 4-point parallel line assay
Stefano Vezzoli, CROPS NT Srl
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SP02: Different Methods of Calculating Body Sway Area
Thomas Wollseifen, i3
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SP04: Use of early longitudinal viral load as a surrogate to the virologic endpoint in Hepatitis C
Igwebuike Enweonye, Business & Decision Life Sciences
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SP06: Embedding equivalence - t-test results in Bland Altman Plots visualising rater reliability
Jim Groeneveld, OCS Consulting
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SP07: An Animated Guide: An Introduction to Latent Class Clustering in SAS
Russell Lavery, Independent Contractor

SP08: Bayesian hypothesis testing for proportions
Antonio Nieto, Sonia Extremera and Javier Gomez, PharmaMar
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Technical Solutions

TS01: Implementation of a CDISC standards supported by global mapping process and metadata library
Dimitri Kutsenko, Entimo AG
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TS02: Using Dynamic Lists in SAS Stored Processes for Genetic Toxicity Historical Control Data
Volker Harm, Bayer Schering Pharma AG
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TS03: Implementing ADaM Using the SAS® Clinical Standards Toolkit
Gene Lightfoot, SAS Institute Inc
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TS04: Scalable Vector Graphics in SAS 9.2
Nicola Tambascia and Sven Greiner, Accovion
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TS05A Comparision of SAS® Verus Microsoft® Excel and Access's Inbuilt VBA Functionality
Jozef Tarrant, Amadeus Software Ltd
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TS06: Know Your Sources - Decoding Inputs/Outputs of any SAS Program
Sandeep Juneja, SAS Institute
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TS07: Customising SAS OQ to Provide Business Specific Testing of SAS Installations and Updates
Steve Huggins, Amadeus Software
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TS08: Data-driven Software Testing for Agile Development
Priyadarshan Shinde and Ajay Sathe, Cytel Statistical Software & Services Pvt. Ltd
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TS09: Rectifying Irregular Text Data: a case for using Regular Expressions in SAS®
Jayshree Garade and Manjusha Gode, Cytel Statistical Software and Services Pvt. Ltd
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TS10: Alternative Approaches to Creating Disposition Flow Diagrams
Brian Fairfield-Carter, ICON Clinical Research
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TS11:Genericity - New Metadata Concepts Applied to SAS Macro Programming
Wolf Dieter Batz, Phenix-MTK GmbH
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Tutorials

TU01: Considerations for improving program performance
Martin Gregory, Merck Serono
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TU02: Go Compare: Flagging up some underused options in PROC COMPARE
Michael Auld, Ampersoft Ltd
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TU03: Chernof face graphs as an efficient way of creating comprehensive Patient Profiles in SAS®
Adam Amborski, Quanticate
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TU04: Some New Features in SAS 9.3 (Overview)
Daniel Christen, SAS Institute AG
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