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SAS Conference Proceedings: Pharmaceutical Users Software Exchange 2016
October 9-12, 2016, Barcelona, Spain, 149 papers
PhUSE 2016   PhUSE 2015   PhUSE 2014   PhUSE 2013   PhUSE 2012   PhUSE 2011   PhUSE 2010   PhUSE 2009   PhUSE 2008   PhUSE 2007   PhUSE 2006   PhUSE 2005  

Pharmaceutical Users Software Exchange 2016: Best Papers and honorable mentions

Making the leap from Excel to a Database used for Reporting
  Shafi Chowdhury, Shafi Consultancy Ltd.; Marco Ackermann, Shafi Consultancy Ltd.; Md. Zobair, Shafi Consultancy Bangladesh (Best Presentation in Applications and Software Development)
Fundamental Advice to Save Time in SAS® Programming
  Mickael Borne, 4Clinics, Paris, France (Best Presentation in Coders Corner)
Analysis Result Metadata… are we there yet?
  Carla Santillan, Chiltern International BVBA, Heverlee, Belgium (Best Presentation in CDISC and Industry Standards)
SAS, Java & Excel - A ménage à trois
  Dana Vinzelberg, Bayer AG, Berlin, Germany (Best Presentation in Coding Solutions)
Calculating the Risk of Re-Identification of Patient-Level Data Using Quantitative Approach
  Lukasz Kniola, Biogen, Maidenhead, UK (Best Presentation in Data Handling)
Interactive Visualization of Linked Data
  Tim Williams, UCB Biosciences Inc., Raleigh, USA (Best Presentation in Data Visualisation)
Playing Detective: Hints and Tips for Independent Programming QC
  Bethan Thomas, PRA Health Sciences, Swansea, United Kingdom (Best Presentation in Industry Starters)
So You’re a Superstar Programmer... ...Why You Still Might Not Be Picked for the Team
  Diana Stuart, Veramed, Twickenham, UK (Best Presentation in Professional Development and Training)
The Tortoise versus the Hare – And the Winner is...
  Meena Rahman, AstraZeneca, Macclesfield, UK; Rebecca Leivers, PAREXEL Informatics, Nottingham, UK (Best Presentation in Poster Presentations)
Planning for Data Reporting Processes for Submission: Key Considerations
  Parag Shiralkar, MBA, M.S., Director, Biometrics Operations and Strategy (Best Presentation in Regulatory)
Real world evidence: a comparison between countries – Common data models and SAS macro catalogs
  Edith M. Heintjes, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands; Jetty A. Overbeek, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands (Best Presentation in Real World Evidence)
Upstream with your statistician and a data visualisation paddle
  Nick Cowans, Veramed, Twickenham, United Kingdom (Best Presentation in Statistics and Pharmacokinetics Programming)
R Beyond Statistics
  Namrata Deshpande, Cytel, Pune, India; (Best Presentation in Trends and Technology)

Applications and Software Development
Coders Corner
CDISC and Industry Standards
Coding Solutions
CDISC Workshops
Data Handling
Data Visualisation
Industry Starters
Management
Professional Development and Training
Poster Presentations
Regulatory
Real World Evidence
Software Demonstrations
Statistics and Pharmacokinetics Programming
Trends and Technology

Applications and Software Development
tweet!  The TFL Workbench: Tools to Standardise and Accelerate Table, Figure, and Listing (TFL) Programming
  Iain Humphreys, PRA Health Sciences, Reading, UK; Hansjörg Frenzel, PRA Health Sciences, Mannheim, Germany
Keywords:  TFL  metadata  SAS  code generation  standards  automation 
Pages: 10 Size: 326 Kb    Download the presentationdownload (.pdf, 2539 Kb)
tweet!  ICON's DIAMOND or an Enhanced Way to Automated Statistical Reporting
  Nathalie Fuchs, ICON Clinical Research Ltd, Illkirch, France
Keywords:  ICON  SAS  DIAMOND  statistical reporting  table  dataset  macro-functions 
Pages: 12 Size: 527 Kb    Download the presentationdownload (.pdf, 4021 Kb)
tweet!  QC of SDTM and aCRF using SAS
  Rune Østergaard Pedersen, S-Cubed, Copenhagen, Denmark; Niels Both, S-Cubed, Copenhagen, Denmark
Keywords:  CDISC 
Pages: 12 Size: 98 Kb    Download the presentationdownload (.pdf, 552 Kb)
tweet!  How to create your Define.xml as early as possible with a click on a button
  Roman Radelicki, SGS - Agriculture, Food and Life, Life Sciences - Clinical Research, Mechelen, Belgium
Keywords:  define.xml  MDR  metadata repository 
Pages: 7 Size: 480 Kb    Download the presentationdownload (.pdf, 1557 Kb)
Efficiency and Delivery Driven by Metadata
  Magnus Mengelbier, Limelogic
  Download the presentationdownload (.pdf, 173 Kb)
Best Presentation
tweet!  Making the leap from Excel to a Database used for Reporting
  Shafi Chowdhury, Shafi Consultancy Ltd.; Marco Ackermann, Shafi Consultancy Ltd.; Md. Zobair, Shafi Consultancy Bangladesh
Keywords:  'Excel'  'Reporting tool'  'Database' 
Pages: 8 Size: 410 Kb    Download the presentationdownload (.pdf, 2429 Kb)
tweet!  A Tool to Automate TFL Bundling
  Mark Crangle, ICON Clinical Research, Marlow, United Kingdom
Pages: 15 Size: 257 Kb    Download the presentationdownload (.pdf, 879 Kb)
tweet!  Peaceful Co-existence: R and SAS
  Martin Gregory, Merck; Manuel Cornes, Merck
Pages: 7 Size: 128 Kb    Download the presentationdownload (.pdf, 240 Kb)
tweet!  Programmed Patient Narratives Using SAS®
  Prafulla Girase, Biogen, Cambridge, USA; Daniel Boisvert, Biogen, Cambridge, USA; Vineeth Kurnala, Biogen, Cambridge, USA
Pages: 7 Size: 522 Kb    Download the presentationdownload (.pdf, 1401 Kb)
tweet!  SAS Environment Upgrade: The PRA Experience
  Gary Stevens, PRA Health Sciences, Reading, UK
Keywords:  SAS version 9.4 Architecture  SAS Enterpise Guide 
Pages: 5 Size: 274 Kb    Download the presentationdownload (.pdf, 1994 Kb)
tweet!  Clinical SAS Application Development in a GRID Environment
  Giri Balasubramanian, PRA Health Sciences, Chennai, India; Edwin Ponraj Thangarajan, PRA Health Sciences, Chennai, India
Keywords:  SDLC  Agile  DevOps  UXDD  SAS  Custom Task  Prototype  V-Model  Iterative  Spiral  Continuous Integration  Continuous Deployment  Application Development  clinical 
Pages: 8 Size: 756 Kb    Download the presentationdownload (.pdf, 5349 Kb)
tweet!  ValidR Enterprise: Developing an R Validation Framework
  Andy Nicholls, Mango Solutions, Chippenham, UK
Keywords:  R  Validation  Framework  Testing  Continuous Integration 
Pages: 11 Size: 682 Kb    Download the presentationdownload (.pdf, 6445 Kb)
Coders Corner
tweet!  Compress It More
  Linda Palm Simonsson, I-Mind, Lund, Sweden
Keywords:  Compress  SAS 
Pages: 5 Size: 609 Kb    Download the presentationdownload (.pdf, 426 Kb)
tweet!  Unicode Characters in a Table of Contents
  John Hendrickx, Danone Nutricia Research, Utrecht, The Netherlands
Keywords:  ODS_RTF  ODS_PROCLABEL  WORD_MACRO  TOC  UNICODE 
Pages: 7 Size: 390 Kb    Download the presentationdownload (.pdf, 765 Kb)
tweet!  Macro-free parsing of multiple text files with SAS
  Adam Amborski, inVentiv Health Clinical, Warsaw, Poland
Keywords:  SAS file input output IO format lrecl varying  macro 
Pages: 5 Size: 390 Kb    Download the presentationdownload (.pdf, 2024 Kb)
tweet!  Colour me useful
  Roberto de Gois, Veramed Ltd, London, United Kingdom
Keywords:  Efficiency  Proc Format  Traffic Light Review System  Reporting Procedures  Proc Print  Proc Report  Proc Tabulate 
Pages: 6 Size: 290 Kb    Download the presentationdownload (.pdf, 508 Kb)
tweet!  Writing Reusable Macros
  Philip R Holland, Holland Numerics Limited
Keywords:  SAS  macros  data sets  macro variables  SAS options  programming 
Pages: 3 Size: 96 Kb    Download the presentationdownload (.pdf, 126 Kb)
tweet!  How Macro Design and Program Structure Impacts GPP (Good Programming Practice) in TLF Coding
  Galyna Repetatska, Chiltern, Kyiv, Ukraine
Keywords:  SAS  GPP  Biometrics  Statistical Programming  TLF  table programming  macro 
Pages: 8 Size: 845 Kb    Download the presentationdownload (.pdf, 2436 Kb)
tweet!  Add Derived Parameters with Multi-Dimensional Arrays
  Siddharth Kumar, GCE Solutions Inc., New Delhi, India
Keywords:  Array  Arrays  Multi-Dimensional  Two-Dimensional  Analysis Dataset  Derived  Parameter  Add  Records  Laboratory  Lab  Clinical  SAS  Siddharth Kumar  Mogra  GCE Solutions  Do loop  nested  output 
Pages: 5 Size: 121 Kb    Download the presentationdownload (.pdf, 5591 Kb)
tweet!  Perish the Sort: Using Indexes and Hash Objects for Efficient Programming
  Jason A Smith, Argo Analytics Ltd, Cambridge, UK
Keywords:  INDEXES  HASH OBJECT  SPDE 
Pages: 8 Size: 406 Kb    Download the presentationdownload (.pdf, 582 Kb)
Best Presentation
tweet!  Fundamental Advice to Save Time in SAS® Programming
  Mickael Borne, 4Clinics, Paris, France
Keywords:  SAS Tips  advice  Efficiency  FCMP  HASH object 
Pages: 11 Size: 66 Kb    Download the presentationdownload (.pdf, 597 Kb)
tweet!  Keeping Track of Database Changes During Database Lock
  Sanjiv Ramalingam, Biogen Inc., Cambridge, USA
Keywords:  track  database  changes  CALL  EXECUTE 
Pages: 6 Size: 322 Kb    Download the presentationdownload (.pdf, 961 Kb)
CDISC and Industry Standards
tweet!  Protocol Representation: The Forgotten CDISC Model
  Jeffrey Abolafia, Rho Inc., Chapel Hill, NC USA; Frank DiIorio, CodeCrafters, Inc., Philadelphia PA USA
Keywords:  PRM  Protocol  CDISC  Metadata 
Pages: 10 Size: 272 Kb    Download the presentationdownload (.pdf, 10416 Kb)
CDASHIG V2.0: What is it Good For?
  Éanna Kiely, CDISC Engineer, Inventiv Health
  Download the presentationdownload (.pdf, 2425 Kb)
tweet!  DIY: Create your own SDTM mapping framework
  Bas van Bakel, OCS Consulting, ‘s-Hertogenbosch, the Netherlands
Keywords:  SDTM  Mapping framework  CDISC 
Pages: 11 Size: 698 Kb    Download the presentationdownload (.pdf, 1155 Kb)
tweet!  Assessing CDISC Therapeutic Area User Guides in a machine readable format
  Johannes Ulander, S-Cubed, Copenhagen, Denmark; Niels Both, S-Cubed, Copenhagen, Denmark
Keywords:  CDISC 
Pages: 4 Size: 308 Kb    Download the presentationdownload (.pdf, 1396 Kb)
tweet!  Device Domains: Examples of their Use in Clinical Trials
  Oksana Voevutska, Chiltern, Kyiv, Ukraine
Keywords:  Device Domains  SDTM  SDTMIG-MD, clinical 
Pages: 12 Size: 453 Kb    Download the presentationdownload (.pdf, 3307 Kb)
tweet!  Analysis Datasets for Baseline Characteristics and Exposure Time for Multi-stage Clinical Trials
  Kimberly Umans, Biogen, Cambridge, USA; Katherine Riester, Biogen, Cambridge, USA; Manjit McNeill, Biogen, Maidenhead, UK; Wei Liu, Biogen, Cambridge, USA; Lukasz Kniola, Biogen, Maidenhead, UK
Keywords:  ADaM  CDISC  dataset  baseline  clinical 
Pages: 5 Size: 55 Kb    Download the presentationdownload (.pdf, 935 Kb)
tweet!  OCCDS – Creating flags or records
  Rob Wartenhorst, GSK Vaccines, Amsterdam, Netherlands
Pages: 4 Size: 123 Kb    Download the presentationdownload (.pdf, 829 Kb)
tweet!  Increasing Work Group Transparency: ADaMIG v1.2 Update and New Team Working Process Review
  Terek J. Peterson, MBA, Chiltern, King of Prussia, PA, USA; Brian Harris, MedImmune, Gaithersburg, MD, USA
Pages: 8 Size: 761 Kb    Download the presentationdownload (.pdf, 1492 Kb)
Constructing A Data Warehouse For Nutrition Clinical Studies
  Paul Vervuren, Danone Nutricia Research, Utrecht, The Netherlands
Keywords:  clinical  warehouse 
  Download the presentationdownload (.pdf, 2464 Kb)
tweet!  Linking Metadata from CDASH to ADaM
  João Gonçalves, Business & Decision Life Sciences, Brussels, Belgium
Keywords:  PhUSE  Conference 
Pages: 6 Size: 505 Kb    Download the presentationdownload (.pdf, 2072 Kb)
Best Presentation
tweet!  Analysis Result Metadata… are we there yet?
  Carla Santillan, Chiltern International BVBA, Heverlee, Belgium
Keywords:  Analysis Result Metadata  ADaM metadata 
Pages: 10 Size: 551 Kb    Download the presentationdownload (.pdf, 1519 Kb)
tweet!  Pattern based Metadata Repository: Toward high quality data standards
  Alan Cantrell, PAREXEL®, Sheffield, United Kingdom; Julius Kusserow, PAREXEL®, Berlin, Germany; Julie James PAREXEL® Informatics, Nottingham, United Kingdom; Deb Copeland, PAREXEL®, Durham, North Carolina, USA; Natraj Patro, PAREXEL®, Billerica, Massachusetts, USA; Isabelle de Zegher, PAREXEL® Informatics, Wavre, Belgium
Keywords:  PAREXEL  CLINICAL  MDR 
Pages: 7 Size: 585 Kb    Download the presentationdownload (.pdf, 1698 Kb)
To Create define.xml using .XML and OpenCDISC Validator
  Murali Neela, GCE solutions, India
Keywords:  CDISC  xml 
  Download the presentationdownload (.pdf, 4547 Kb)
tweet!  Out-of-the-box %defineXML – Just a Simple SAS Macro
  Katja Glaß, Bayer Pharma AG, Berlin, Germany
Keywords:  macro  xml 
Pages: 11 Size: 941 Kb    Download the presentationdownload (.pdf, 4530 Kb)
tweet!  How to handle different versions of SDTM & DEFINE generation in a Single Study?
  Edwin Ponraj Thangarajan, PRA Health Sciences, Chennai, India; Giri Balasubramanian, PRA Health Sciences, Chennai, India
Keywords:  CDISC SDTM  Define-XML  Data Standards  EXACT 
Pages: 22 Size: 3569 Kb    Download the presentationdownload (.pdf, 8735 Kb)
A Moratorium on the Standards Madness
  Scott Bahlavooni, d-Wise, Morrisville, NC, USA
  Download the presentationdownload (.pdf, 4632 Kb)
tweet!  Understanding the potential of Share: a visual business case and technical use case
  Peter Van Reusel, Business & Decision Life Sciences, Brussels, Belgium
Pages: 4 Size: 136 Kb    Download the presentationdownload (.pdf, 17216 Kb)
Coding Solutions
tweet!  Boosting the efficiency of data review by using SAS Integration Technologies and VBA
  Giuseppe Di Monaco, UCB BioSciences GmbH, Monheim, Germany
Keywords:  VBA  SAS IOM  Integrated Object Model 
Pages: 9 Size: 871 Kb    Download the presentationdownload (.pdf, 1268 Kb)
Best Presentation
tweet!  SAS, Java & Excel - A ménage à trois
  Dana Vinzelberg, Bayer AG, Berlin, Germany
Keywords:  Coding  Solutions  2016 
Pages: 8 Size: 462 Kb    Download the presentationdownload (.pdf, 7995 Kb)
tweet!  Exploring Newer Techniques in SAS to Enhance Interactive Web Applications
  Volker Harm, Bayer Pharma AG, Berlin, Germany
Keywords:  PROC STREAM  FUNCTION DOSUBL  PROC JSON  ODS HTML5  internet 
Pages: 3 Size: 115 Kb    Download the presentationdownload (.pdf, 3000 Kb)
tweet!  Reducing Build Time of Integrated Clinical Databases with SAS® Grid and SAS/OR®
  Eric Brinsfield, Meridian Analytics, Virginia Beach, VA, USA and d-Wise Technologies, Inc., Morrisville, NC, USA
Keywords:  SAS CPM GRID PARALLEL PROCESSING INTEGRATED DATABASE SAS/OR  clinical 
Pages: 11 Size: 730 Kb    Download the presentationdownload (.pdf, 1049 Kb)
tweet!  Dictionary tables a programmer's friend?
  Marcin Pracz, Quintiles, Warsaw, Poland
Pages: 5 Size: 266 Kb    Download the presentationdownload (.pdf, 2375 Kb)
tweet!  Coding WHO-DDE: an automatic, easy and powerful SAS® tool
  Gianluca Mortari, CROS NT, Verona, Italy
Pages: 11 Size: 590 Kb    Download the presentationdownload (.pdf, 1535 Kb)
tweet!  Get a Jump Start on Clinical Data Analysis and Visualization with Standard Scripts
  Jared Slain, MPI Research, Mattawan, USA; Hanming Tu, Accenture, Berwyn, USA
Keywords:  2016 PhUSE Annual Conference  clinical 
Pages: 20 Size: 1240 Kb    Download the presentationdownload (.pdf, 3700 Kb)
tweet!  CompareDirectory - Macro bits and pieces in action
  Lawrence Heaton-Wright, Quintiles IMS, Reading, UK
Keywords:  macro 
Pages: 7 Size: 354 Kb    Download the presentationdownload (.pdf, 918 Kb)
tweet!  Top 10 uses of macro %varlist - in proc SQL, Data Step and elsewhere
  Jean-Michel Bodart, Business & Decision Life Sciences, Brussels, Belgium
Keywords:  VARLIST  usage  survey  examples  utility  macro-function  SAS  Phuse Barcelona 2016  Coding Solutions 2016  Conference Paper  SQL 
Pages: 12 Size: 490 Kb    Download the presentationdownload (.pdf, 3349 Kb)
CDISC Workshops
What's New in CDISC
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
Keywords:  CDISC 
  Download the presentationdownload (.pdf, 4980 Kb)
Exercise: Define v2.0 and the Need for Value Level Metadata
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the presentationdownload (.pdf, 1586 Kb)
Standards Conceptual Model - Understanding the potential of Share
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the presentationdownload (.pdf, 16044 Kb)
Live Demo
  Peter Van Reusel, Business & Decision Life Sciences; Nick De Donder, Business & Decision Life Sciences; David Iberson-Hurst, Assero
  Download the demodownload (.mp4, 31043 Kb)   Download the presentationdownload (.pdf, 3149 Kb)
Data Handling
tweet!  Effective use of a Metadata Repository across data operations: the need for a machine readable form of the protocol
  Isabelle de Zegher, PAREXEL Informatics, Wavre, Belgium; Michele Gray, PAREXEL International, Philadelphia, United States; Mark Sullivan, PAREXEL Informatics, Boston, United States; Michael Goedde, PAREXEL International, Boston, United States
Pages: 5 Size: 1160 Kb    Download the presentationdownload (.pdf, 2492 Kb)
tweet!  Data De-Identification Made Simple
  Jørgen Mangor Iversen, LEO Pharma A/S, Ballerup, Denmark
Keywords:  De-Identification  redaction 
Pages: 6 Size: 198 Kb    Download the presentationdownload (.pdf, 1143 Kb)
tweet!  Grading Lab Toxicities using NCI- Common Terminology Criteria for Adverse Events (CTCAE)
  Srinivas Veeragoni, BHC Pharmaceuticals Inc., Whippany, USA; Ankur Mathur, Bayer Inc., Toronto, Canada
Keywords:  CTCAE  Toxicity  Grading Lab values 
Pages: 10 Size: 810 Kb    Download the presentationdownload (.pdf, 2241 Kb)
Integrating the New EMA Requirements on Public Disclosure in the Study Conduct
  Jean-Marc Ferran, Qualiance
  Download the presentationdownload (.pdf, 6363 Kb)
tweet!  How a Metadata Repository enables dynamism and automation in SDTM-like dataset generation
  Judith Goud, Akana, Bennekom, The Netherlands; Priya Shetty, Intelent, Princeton, USA
Keywords:  Metadata  MDR  automated SAS dataset generation  dynamism  CDISC 
Pages: 7 Size: 1785 Kb    Download the presentationdownload (.pdf, 1911 Kb)
tweet!  A Standardized Approach to De-Identification
  Benoit Vernay, Novartis, Basel, Switzerland; Ravi Yandamuri, MMS Holdings Inc., Canton, USA
Keywords:  standard  deidentification  de-identification  anonymization  process  privacy  data  EMA  policy  MSE  HIPAA  metadata  SAS  sharing  transparency 
Pages: 13 Size: 794 Kb    Download the presentationdownload (.pdf, 3326 Kb)
tweet!  How to review a CRF - A statistical programmer perspective
  Elsa Lozachmeur, Novartis Pharma AG, Basel, Switzerland
Pages: 7 Size: 271 Kb    Download the presentationdownload (.pdf, 970 Kb)
tweet!  Efficiency Comes From Reusability and Repeatability
  Hanming Tu, Accenture, Berwyn, USA; Dave Evans, Accenture, Berwyn, USA
Keywords:  Data Conversion  ETL  CDISC SDTM  Metadata Standard  Code Reusability  Process Repeatability  Efficiency Level Matrix  Intelligent Data Flow 
Pages: 10 Size: 673 Kb    Download the presentationdownload (.pdf, 6355 Kb)
Best Presentation
tweet!  Calculating the Risk of Re-Identification of Patient-Level Data Using Quantitative Approach
  Lukasz Kniola, Biogen, Maidenhead, UK
Keywords:  Anonymisation  De-identification  Risk assessment  Quantitative Approach 
Pages: 9 Size: 310 Kb    Download the presentationdownload (.pdf, 12745 Kb)
tweet!  Metadata on the go: Achieving metadata accuracy and consistency continually
  Swapna Pothula, SGS Life Sciences, Mechelen, Belgium
Keywords:  Metadata  MDRs  CDISC  SDTM  Pinnacle21 
Pages: 6 Size: 268 Kb    Download the presentationdownload (.pdf, 1333 Kb)
tweet!  How to effectively deal with hardcoding and CDISC Controlled Terminology in clinical studies
  Lennert van der Zee, OCS Consulting, ‘s-Hertogenbosch, the Netherlands
Keywords:  CDISC  clinical 
Pages: 10 Size: 545 Kb    Download the presentationdownload (.pdf, 1253 Kb)
tweet!  Data sharing 3 years on – from baby to toddler ...
  Katherine Tucker, Roche Products Limited, Welwyn Garden City, UK
Pages: 10 Size: 638 Kb    Download the presentationdownload (.pdf, 1319 Kb)
tweet!  From SDTM to displays, through ADaM & Analyses Results Metadata, a flight on board METADATA Airlines
  Omar SEFIANI, Boehringer Ingelheim, Reims, France; Stéphane BOUGET, Boehringer Ingelheim, Reims, France
Keywords:  DH13 - PhUSE 2016  CDISC 
Pages: 10 Size: 390 Kb    Download the presentationdownload (.pdf, 1585 Kb)
Data Visualisation
tweet!  Interactive visualisation for Precision and Translational Medicine
  Dr. Christof Gaenzler, PerkinElmer Informatics, Rodgau, Germany
Pages: 3 Size: 339 Kb    Download the presentationdownload (.pdf, 2082 Kb)
tweet!  Communicating results with R&Shiny
  Mika Mäkinen, Roche, Basel, Switzerland
Keywords:  DV02 
Pages: 9 Size: 248 Kb    Download the presentationdownload (.pdf, 1055 Kb)
tweet!  Interactive Data Visualization and Exploration Using the Loon R Package
  Adrian Waddell, F. Hoffmann-La Roche, Basel, Switzerland
Keywords:  Interactive Data Visualization  Loon  R  Adverse Events 
Pages: 8 Size: 323 Kb    Download the presentationdownload (.pdf, 9928 Kb)
tweet!  Clinical Graphs using SAS
  Sanjay Matange, SAS Institute Inc. Cary, USA
Keywords:  clinical 
Pages: 12 Size: 1081 Kb    Download the presentationdownload (.pdf, 3515 Kb)
tweet!  A Cost-Effective Data Visualisation System using BASE SAS
  Kevin Kane, Phastar
Pages: 1 Size: 46 Kb 
Best Presentation
tweet!  Interactive Visualization of Linked Data
  Tim Williams, UCB Biosciences Inc., Raleigh, USA
Keywords:  Resource Description Framework  RDF  Linked Data  Graph Data  Properties Graph  SPARQL  Cypher  Neo4j  D3  D3js  Virtuoso  Data Visualization  R 
Pages: 8 Size: 691 Kb    Download the presentationdownload (.pdf, 3395 Kb)
tweet!  Clinical Data in Business Intelligence
  Mike Collinson, Oracle Heath Sciences Consulting (HSC), Reading, UK
Keywords:  SDTM  Business Intelligence  Oracle  Oracle Health Sciences Consulting  HSC, clinical 
Pages: 7 Size: 546 Kb    Download the presentationdownload (.pdf, 1984 Kb)
tweet!  End-to-end data and metadata: It's not only a dream, it’s a reality
  Gérald NEVEU, Danone Nutricia Research, Palaiseau, France
Pages: 6 Size: 332 Kb    Download the presentationdownload (.pdf, 3023 Kb)
tweet!  Concepts and Strategies for Developing Effective Data Visualizations
  Becky Bates, GCE Solutions, Bloomington, IL, USA
Pages: 5 Size: 404 Kb    Download the presentationdownload (.pdf, 1708 Kb)
Industry Starters
tweet!  Adventures in Data Science
  Kieran Martin, Roche, Welwyn Garden City, UK
Keywords:  Data Science  Big Data 
Pages: 9 Size: 443 Kb    Download the presentationdownload (.pdf, 1606 Kb)
tweet!  The hardships of finding your way in biometrics
  R.E. Creebsburg, OCS Consulting, ‘s-Hertogenbosch, The Netherlands
Pages: 4 Size: 233 Kb    Download the presentationdownload (.pdf, 894 Kb)
tweet!  How well can you speak SAS or is what you see what you get?
  Yuliia Bahatska, inVentiv Health Clinical, Berlin, Germany
Keywords:  SAS Test  unexpected result  minor errors 
Pages: 7 Size: 57 Kb    Download the presentationdownload (.pdf, 312 Kb)
Best Presentation
tweet!  Playing Detective: Hints and Tips for Independent Programming QC
  Bethan Thomas, PRA Health Sciences, Swansea, United Kingdom
Pages: 11 Size: 467 Kb    Download the presentationdownload (.pdf, 1323 Kb)
tweet!  Good Programming Practice and Its Importance in the New World of Metadata
  Jennifer Chin, Eisai Ltd, Hatfield, UK; Shafi Chowdhury, Shafi Consultancy, Uxbridge, UK; Mark Foxwell, PRA Health Sciences, Reading, UK
Pages: 6 Size: 165 Kb    Download the presentationdownload (.pdf, 927 Kb)
tweet!  Get kitted out – A practical guide to SAS certifications, MOOCs and hands-on experience
  Hannes Engberg Raeder, PRA Health Sciences, Mannheim, Germany
Pages: 6 Size: 116 Kb    Download the presentationdownload (.pdf, 5331 Kb)
tweet!  Developing Better Training Guides
  Alastair Scarlett, d-Wise, London, England
Keywords:  Training  Guides 
Pages: 8 Size: 297 Kb    Download the presentationdownload (.pdf, 2086 Kb)
Management
Developing Agile and Adaptive Processes in the Modern Fast-packed Data Rich World
  Sam Warden, d-Wise; Chris Price, Roche; Shafi Chowdhury, Shafi Consultancy
  Download the presentationdownload (.pdf, 678 Kb)
Dancing withthe Grizzly – An interactive workshop to define the perfect SCE (Statistical Computing Environment) Implementation Project for a Global Biopharmaceutical Company
  James McDermott, Ab Tartarus; Jean-Marc Ferran, Qualianc
Enhanced Data Analytics: A Reality Check of Aspiration, Current Progress and Organisational Implementation
  Christian Mueller, Roche; Sascha Ahrweiler, Bayer; Leo Valmas, Quintiles; Jari Ahvenainen, Aastat
Professional Development and Training
tweet!  The Process and Development of the SAS/STAT® Programmer Role from a Retroactive Perspective
  Jonathan Bishop, PRA Health Sciences, Swansea, Wales, UK
Pages: 1 Size: 63 Kb    Download the presentationdownload (.pdf, 4699 Kb)
tweet!  Size doesn’t matter: Little fish can be leaders too
  Jennifer Dootson, d-wise, Manchester, UK
Pages: 4 Size: 370 Kb    Download the presentationdownload (.pdf, 14082 Kb)
tweet!  Why programmers make the best functional leads: do statisticians really know best?
  Tom Ward, PPD, Cambridge, UK
Keywords:  Why  programmers  make  the  best  functional  leads:  do  statisticians  really  know  best? 
Pages: 5 Size: 520 Kb    Download the presentationdownload (.pdf, 889 Kb)
tweet!  Continuous Improvement for TFL production
  Caroline Terrill, CROS NT, Maidenhead, UK
Keywords:  Continuous improvement  macro development 
Pages: 5 Size: 121 Kb    Download the presentationdownload (.pdf, 5888 Kb)
tweet!  How to Enjoy Working in Virtual Teams
  Petra Auclair, F. Hoffmann-La Roche, Basel, Switzerland; Antje Rossmanith, F. Hoffmann-La Roche, Basel, Switzerland
Keywords:  Virtual  Teams  Communication  Relationship  Leadership 
Pages: 4 Size: 111 Kb    Download the presentationdownload (.pdf, 2249 Kb)
tweet!  Program-level Programming Strategy – Oh, I Wish I’d thought of that Beforehand!!
  Jennie McGuirk, ICON PLC, Dublin, Ireland
Pages: 9 Size: 197 Kb    Download the presentationdownload (.pdf, 1752 Kb)
tweet!  Desired Competencies for Speed and Efficiency (in the Drug Approval Process)
  R. Mouly Satyavarapu, inVentiv Health, Cary, North Carolina, USA
Pages: 4 Size: 108 Kb    Download the presentationdownload (.pdf, 2321 Kb)
Best Presentation
tweet!  So You’re a Superstar Programmer... ...Why You Still Might Not Be Picked for the Team
  Diana Stuart, Veramed, Twickenham, UK
Pages: 5 Size: 116 Kb    Download the presentationdownload (.pdf, 3103 Kb)
tweet!  On the Fast Lane to a Successful Submission – A Lead Programmer’s Guide to an Efficient and High-Quality Submission Programming Deliverable
  Michael Reich, PRA Health Sciences, Mannheim, Germany; Hannes Engberg Raeder, PRA Health Sciences, Mannheim, Germany; Jim Witt, PRA Health Sciences, Mannheim, Germany; Doris Kolb, PRA Health Sciences, Mannheim, Germany
Keywords:  Submission  FDA  NDA  ISS  ISE  Lead Programmer 
Pages: 9 Size: 79 Kb    Download the presentationdownload (.pdf, 17297 Kb)
tweet!  Is the Statistical Programming Process LEAN Enough?
  Simon Jennings, ICON Ltd, Marlow, UK
Keywords:  Lean  Six Sigma: DMAIC  SIPOC  Voice of the Customer  Metrics 
Pages: 9 Size: 776 Kb    Download the presentationdownload (.pdf, 4488 Kb)
tweet!  Integration & Innovation: Pharma-CRO Relationship
  Nalin Gupta, GCE Solutions, Bloomington, IL, USA; Rebecca Bates, GCE Solutions, Bloomington, IL, USA
Pages: 2 Size: 218 Kb    Download the presentationdownload (.pdf, 2843 Kb)
Poster Presentations
tweet!  SAS Grid Migration - Challenges, Solutions and Learnings
  Amol Waykar, d-Wise; Eric Brinsfield, d-Wise
Pages: 1 Size: 1721 Kb    Download the presentationdownload (.pdf, 361 Kb)
tweet!  Efficiently Converting Datasets to Vertical Structure using Metadata
  Thevaki Mahadevan, Syne Qua Non, Norfolk, UK
Keywords:  horizontal dataset  vertical dataset  proc contents  proc transpose  array 
Pages: 6 Size: 342 Kb    Download the presentationdownload (.pdf, 526 Kb)
tweet!  CONSORT Diagram: Doing it with SAS
  Anusha Mallavarapu, Cytel, Pune, India; Dean Shults, Cytel, UK
Keywords:  CONSORT  Diagram 
Pages: 4 Size: 242 Kb    Download the presentationdownload (.pdf, 188 Kb)
tweet!  Using Meta Data to drive standards, speed, consistency and quality in reporting
  Shafi Chowdhury, Shafi Consultancy Limited, U.K.; Daniel Boisvert,Biogen, U.S.A
Keywords:  'Meta data'  'auto-generate'  'reports' 
Pages: 6 Size: 49 Kb    Download the presentationdownload (.pdf, 92 Kb)
tweet!  Early Data Review
  Graham Oakley, ICON PLC
Keywords:  Early  Data  Review  Engage  Communication  Confidence 
Pages: 1 Size: 265 Kb    Download the presentationdownload (.pdf, 265 Kb)
tweet!  Developing MDR Metadata Requirements for Operational Implementation
  Andy Richardson, d-Wise, Manchester, UK.; Scott Bahlavooni, d-Wise, Morrisville, NC, USA
Pages: 5 Size: 437 Kb    Download the presentationdownload (.pdf, 241 Kb)
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tweet!  The Tortoise versus the Hare – And the Winner is...
  Meena Rahman, AstraZeneca, Macclesfield, UK; Rebecca Leivers, PAREXEL Informatics, Nottingham, UK
Keywords:  Randomisation/Unblinding  Solution 
Pages: 4 Size: 160 Kb    Download the presentationdownload (.pdf, 56 Kb)
tweet!  Creating a PDF file containing multiple outputs
  Spencer Renyard, Phastar, London, UK
Keywords:  PDF  PhUSE  2016  Poster  PP09 
Pages: 2 Size: 92 Kb    Download the presentationdownload (.pdf, 947 Kb)
tweet!  Non-Printable and Special Characters? … BYTE me!
  Louise Sims, Phastar Ltd., London, UK
Keywords:  SAS  NPSC  BYTE  NOTPRINT  RANK 
Pages: 12 Size: 633 Kb    Download the presentationdownload (.pdf, 787 Kb)
tweet!  Automating ADaM - How to Efficiently Create CDISC ADaM Specifications and Automate their Transformation into Datasets
  H.C. Hart
Keywords:  CDISC 
Pages: 3 Size: 35 Kb    Download the presentationdownload (.pdf, 266 Kb)
tweet!  Implementation Effort Estimation: Important Aspects
  Patrick René Warnat, HMS Analytical Software GmbH, Heidelberg, Germany
Keywords:  effort  estimation 
Pages: 3 Size: 81 Kb    Download the presentationdownload (.pdf, 261 Kb)
tweet!  Shopping for your CRF: Combining sources for a simple data collection browser
  Rod Bower, Roche, Welwyn Garden City, UK
Keywords:  CRF  Standards  ODV 
Pages: 5 Size: 374 Kb    Download the presentationdownload (.pdf, 1394 Kb)
tweet!  Operational Data and Submissions Strategy
  Ester Schoeman, Biogen, Maidenhead, UK; Joanna Koft, Biogen, Cambridge, MA
Pages: 1 Size: 52 Kb 
tweet!  Automating Frequency Tables with ClinXport SAS Macro Package
  Loizos Nicolaou, ClinBAY, Limassol, Cyprus; Julien Vanwinsberghe, ClinBAY, Genappe, Belgium
Keywords:  Frequency Tables  SAS macro  rep_aev  ClinXport  Adverse Events 
Pages: 6 Size: 584 Kb    Download the presentationdownload (.pdf, 696 Kb)
tweet!  Cross-over to High Quality Graphics: Using SGRENDER to Enhance Graphics in a Cross-Over Study
  Martin Clancy, Quantitate; Simon Clancy, Quantitate; Sue McKendrick, Quantitate; Utpal Sanki, Quantitate
Pages: 1 Size: 712 Kb    Download the presentationdownload (.pdf, 712 Kb)
tweet!  Stylizing your SAS graph – A needs-based approach
  Jerome Lechere, Novartis, Basel, Switzerland
Keywords:  ODS Styles  Style element  attribute option  Styleattrs statement  Attribute map dataset 
Pages: 22 Size: 788 Kb    Download the presentationdownload (.pdf, 1387 Kb)
tweet!  Fast and high quality validation process
  Alessia Sacco, Valos, Genova, Italy; Dmitri Petratchenko, Valos, Genova, Italy; Andrea Parodi, Valos, Genova, Italy
Pages: 7 Size: 570 Kb    Download the presentationdownload (.pdf, 689 Kb)
tweet!  The development of standards management using EntimICE-AZ
  Shyamprasad Perisetla, AstraZeneca, Cambridge, UK; Per-Arne Stahl, AstraZeneca, Mölndal, Sweden
Pages: 5 Size: 299 Kb    Download the presentationdownload (.pdf, 1616 Kb)
tweet!  Fast track to Domain: SDTM.PC and SDTM.PP Use Graphic overview of variables to speed up learnings curve.
  Lina Ulkjær Jørgensen, Novo Nordisk A/S, Bagsværd, Denmark
Keywords:  CDISC 
Pages: 2 Size: 83 Kb    Download the presentationdownload (.pdf, 116 Kb)
tweet!  Reflections on the Effects of Data Pooling
  Catharina Dahlbo, Capish Nordic AB, Malmö, Sweden
Keywords:  Data pooling  data curation 
Pages: 4 Size: 263 Kb    Download the presentationdownload (.pdf, 759 Kb)
tweet!  KeyDAN: Risk Minimization in Data Anonymization
  Stéphane Chollet, Keyrus Biopharma, Levallois-Perret, France; Mathilde Laffitte, Keyrus Biopharma, Lasne, Belgium
Pages: 6 Size: 407 Kb    Download the presentationdownload (.pdf, 930 Kb)
tweet!  Constructing Interoperable Study Documents From A Semantic Technology-based Repository
  Colin de Klerk, UCB BioSciences GmbH, Monheim, Germany
Keywords:  Semantic technologies  CMS  Study Protocol 
Pages: 12 Size: 895 Kb    Download the presentationdownload (.pdf, 1340 Kb)
tweet!  Scientific Data Curation: Efficiently extracting structured data from publications
  Rupali Desai, Cytel, Pune, India; Nand Kishore Rawat, Cytel, Pune, India
Keywords:  Data Curation  Efficiency  Cytel 
Pages: 11 Size: 862 Kb    Download the presentationdownload (.pdf, 729 Kb)
Regulatory
tweet!  What is high quality study metadata?
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA, USA; Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA, USA
Pages: 9 Size: 384 Kb    Download the presentationdownload (.pdf, 728 Kb)
Best Presentation
tweet!  Planning for Data Reporting Processes for Submission: Key Considerations
  Parag Shiralkar, MBA, M.S., Director, Biometrics Operations and Strategy
Pages: 2 Size: 39 Kb    Download the presentationdownload (.pdf, 567 Kb)
tweet!  Japanese Electronic Study Data Submission in CDISC Formats
  Yuichi Nakajima, Novartis Pharma K.K, Tokyo, Japan; Takashi Kitahara, Novartis Pharma K.K, Tokyo, Japan; Ryan Hara, Novartis Pharma AG, Basel, Switzerland
Keywords:  PMDA  FDA  CDISC  electronic study data submission  Pinncale 21  legacy data  consultation 
Pages: 8 Size: 294 Kb    Download the presentationdownload (.pdf, 1232 Kb)
tweet!  What auditors want
  Cedric Marchand, Cytel Inc., Geneva, Switzerland; Angelo Tinazzi, Cytel Inc., Geneva, Switzerland
Pages: 8 Size: 396 Kb    Download the presentationdownload (.pdf, 1072 Kb)
tweet!  Case Study in Support of German Payer Evidence
  Frank Senk, GCE Solutions, Bloomington, IL, USA
Pages: 5 Size: 212 Kb    Download the presentationdownload (.pdf, 270 Kb)
Real World Evidence
tweet!  The Playbook: from Real World Data to Real World Intelligence
  Laurie Rose, SAS, Cary, NC United States; Robert Collins, SAS, Cary, NC United States
Pages: 7 Size: 1272 Kb    Download the presentationdownload (.pdf, 2803 Kb)
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tweet!  Real world evidence: a comparison between countries – Common data models and SAS macro catalogs
  Edith M. Heintjes, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands; Jetty A. Overbeek, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands
Keywords:  RWE  multicountry study  SAS macro catalog  common data model 
Pages: 7 Size: 248 Kb    Download the presentationdownload (.pdf, 1297 Kb)
Proposal of a General Macro Framework for Propensity-score Matching
  Holger Langkabel, Roche
Keywords:  macro 
  Download the presentationdownload (.pdf, 564 Kb)
tweet!  An Algorithm To Distinguish Between COPD and Asthma
  Berber T. Snoeijer, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands; Jetty A. Overbeek, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands
Pages: 3 Size: 153 Kb    Download the presentationdownload (.pdf, 1716 Kb)
tweet!  Considerations in the Use of Propensity Scores in Observational Studies
  Lawrence Rasouliyan, RTI Health Solutions, Barcelona, Spain; Estel Plana, RTI Health Solutions, Barcelona, Spain; Jaume Aguado; RTI Health Solutions, Barcelona, Spain
Pages: 17 Size: 330 Kb    Download the presentationdownload (.pdf, 1003 Kb)
What Have I Done? Analysis Specifications Document for Retrospective Database Studies
  Knut Mueller, UCB Biosciences
  Download the presentationdownload (.pdf, 878 Kb)
Software Demonstrations
tweet!  Data Standards Governance
  João Gonçalves, Business & Decision Life Sciences, Brussels, Belgium; Jean-Michel Meeus, Business & Decision Life Sciences, Brussels, Belgium
Keywords:  PhUSE  Conference 
Pages: 6 Size: 1194 Kb    Download the presentationdownload (.pdf, 1177 Kb)
tweet!  Fast track to define.xml v2.0 – SDTM and ADaM
  Jörn Bilow, Entimo AG, Berlin, Germany
Keywords:  define CDISC SDTM ADaM  xml 
Pages: 4 Size: 83 Kb    Download the presentationdownload (.pdf, 2621 Kb)
Pinnacle 21 Enterprise - Facilitationg eSubmission Preparation
  Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA, USA
  Download the presentationdownload (.pdf, 3658 Kb)
tweet!  EnForeSys - an Advanced Patient Enrollment Forecaster with Monte Carlo Simulations
  Ritika Yadav, Cytel, Pune, India; Swechhya Bista, Cytel, Pune, India
Keywords:  EnForeSys, Monte Carlo, Patient enrollment  recruitment, clinical trial 
Pages: 12 Size: 699 Kb    Download the presentationdownload (.pdf, 2284 Kb)
tweet!  Blur Software Demonstration
  Cathal Gallagher, d-Wise, Manchester, UK
Pages: 3 Size: 36 Kb    Download the presentationdownload (.pdf)
encapsia™ – Providing Real-time, Interactive Visualisations of Clinical Data
  Jon Carter, Cmed
Keywords:  clinical 
  Download the presentationdownload (.pdf, 2765 Kb)
SAS Studio – Getting to Know SAS Studio
  Andy Bayliss, SAS
  Download the presentationdownload (.pdf, 1133 Kb)
tweet!  Standard Safety Visualization Set-up Using Spotfire
  Michaela Mertes, F. Hoffmann-La Roche, Ltd., Basel, Switzerland
Pages: 10 Size: 923 Kb    Download the presentationdownload (.pdf, 3569 Kb)
Statistics and Pharmacokinetics Programming
tweet!  Standard Methods for Analysis and Reporting of VAS or NRS Derived Pain Relief Response Scores
  James R. Johnson, Flexion Therapeutics, Inc., Cary, NC USA
Keywords:  Statistical  Methods 
Pages: 14 Size: 319 Kb    Download the presentationdownload (.pdf, 442 Kb)
tweet!  Probability plots as an instrument for comparing distributions
  Holger Langkabel, Roche, Basel, Switzerland
Keywords:  Q-Q plots  data visualization  non-parametric methods 
Pages: 9 Size: 397 Kb    Download the presentationdownload (.pdf, 666 Kb)
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tweet!  Upstream with your statistician and a data visualisation paddle
  Nick Cowans, Veramed, Twickenham, United Kingdom
Keywords:  Data cleaning  Data management  Visual tools 
Pages: 6 Size: 239 Kb    Download the presentationdownload (.pdf, 2050 Kb)
tweet!  Multiplicity Issues in Clinical Trials-Look at it with a magnifying glass!
  Madhusudhan Bandi, Hyderabad, India
Keywords:  Multiplicity  False positive rate  Family wise error rate  False discovery rate  Hypothesis  Alpha  Power  clinical 
Pages: 6 Size: 578 Kb    Download the presentationdownload (.pdf, 140 Kb)
tweet!  Using graphics to review and present PK/PD data for maximum impact
  Md. Rajwanur Rahman, Shafi Consultancy Bangladesh; Shafi Chowdhury, Shafi Consultancy Ltd.; Marco Ackermann, Shafi Consultancy Ltd.
Keywords:  PK/PD  Graphics  NONMEM 
Pages: 9 Size: 550 Kb 
Trends and Technology
tweet!  Does the concept of a “Sentient-Enterprise” apply to the clinical trial execution process?
  Peter Grolimund, Teradata, Zurich, Switzerland
Keywords:  clinical 
Pages: 7 Size: 745 Kb    Download the presentationdownload (.pdf, 7847 Kb)
tweet!  SCAPROC Impact Analysis - Providing QA and Compliance Insights
  Sandeep Juneja, SAS Institute, Cary NC; Ben Bocchicchio, SAS Institute, Cary NC; Stijn Rogiers, SAS Institute, Belgium
Pages: 6 Size: 1135 Kb    Download the presentationdownload (.pdf, 966 Kb)
tweet!  An Update from the PhUSE Working Group on Cloud Adoption in the Regulated Life Science Industry
  Tony Hewer, Medidata Solutions Inc, London, UK
Pages: 33 Size: 5466 Kb    Download the presentationdownload (.pdf, 2305 Kb)
tweet!  Creating a single instance / multi tenant eClinical Platform
  ClinPal
Keywords:  clinical 
Pages: 16 Size: 224 Kb    Download the presentationdownload (.pdf, 10776 Kb)
tweet!  Generating Analysis Results and Metadata - report from a PhUSE CS project
  Marc Andersen, StatGroup ApS, Copenhagen, Denmark; Marcelina Hungria, DIcore Group, LLC, NJ, USA; Suhas R. Sanjee, Merck & Co., Inc., Kenilworth, NJ USA
Pages: 10 Size: 1203 Kb    Download the presentationdownload (.pdf, 683 Kb)
tweet!  Reflect on your data
  Dr Peter Tormay, Capish Nordic AB, Malmö, Sweden; Henrik Drews, Capish Nordic AB, Malmö Sweden
Keywords:  graph database  data integration  node indices  relation index  property graph database 
Pages: 9 Size: 728 Kb    Download the presentationdownload (.pdf, 19305 Kb)
Best Presentation
tweet!  R Beyond Statistics
  Namrata Deshpande, Cytel, Pune, India;
Keywords:  R  Automation  gWidgets  ReporteRs 
Pages: 12 Size: 484 Kb    Download the presentationdownload (.pdf, 4791 Kb)
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