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FDA/PhUSE CSS Conference Proceedings: FDA/PhUSE US Computational Science Symposium 2013
March 18-19, 2013, Silver Spring, Maryland, 25 papers
FDA/PhUSE CSS 2012   FDA/PhUSE CSS 2013   FDA/PhUSE CSS 2014   FDA/PhUSE CSS 2015   FDA/PhUSE CSS 2016   FDA/PhUSE CSS 2017  

[Original source: http://www.phuse.eu/css-presentations-2013]

FDA/PhUSE US Computational Science Symposium 2013: Best Papers and honorable mentions

Clinical Analysis and Reporting Environment (CARE) - The Industrialization of Clinical Trail Analysis and Reporting
  Greg Fuller, Independent (Industry Poster Winner in Posters)
JANUS CTR Data and Cross Study Analysis at FDA
  Helena Sviglin, FDA; Iffat Chowdhury, FDA; Bobbie Witczak, FDA (FDA Poster Winner in Posters)


tweet!  Strategies for Preparing and Validating Submission Data
  Sandeep Juneja, SAS Institute Inc; Frank Rodiger, SAS Institute Inc
Pages: 1 Size: 123 Kb 
tweet!  Relating PC and PP Domains using RELREC Records
  Peter Schaefer, Pharsight
Pages: 1 Size: 3170 Kb 
tweet!  Active PURLs for Clinical Study Aggregation
  David Wood, 3 Round Stones; Tom Plasterer, AstraZeneca
Pages: 1 Size: 3677 Kb 
Industry Poster Winner
tweet!  Clinical Analysis and Reporting Environment (CARE) - The Industrialization of Clinical Trail Analysis and Reporting
  Greg Fuller, Independent
Pages: 1 Size: 1844 Kb 
tweet!  Specifications Like This - A Framework for Automatic Generation of Program Code and Documentation
  Marc Andersen, StatGroup APS
Pages: 1 Size: 300 Kb 
tweet!  Conversion of Legacy Data from Topical Corticosteroid Clinical Studies to SDTM Format
  Hon-Sum Ko, FDA; Elizabeth Gaudio, FDA
Pages: 1 Size: 165 Kb 
tweet!  Web-based Integrated Summary of Safety Exposure Response Analysis
  Jens Stampe Soerensen, FDA; Ider Peter Lee, FDA
Pages: 1 Size: 608 Kb 
tweet!  Bringing Non-CDISC Datasets into a CDISC World with Reproducible Output
  Nate Freimark, Theorem Clinical Research; Victor Falch, Theorem Clinical Research
Pages: 1 Size: 203 Kb 
tweet!  Data Quality in Submissions: A Missing Link
  Kit Howard, Kestrel Consultants
Pages: 1 Size: 24989 Kb 
tweet!  A Collaborative, Cloud Hosted Environment for Simulating CDISC SEND Submissions between CROs, Sponsors
  Shree Nath, PointCross Life Sciences; Heather Williams, PointCross Life Sciences; Jackson Zalki, PointCross Life Sciences
Pages: 1 Size: 560 Kb 
tweet!  Quantitative Systems Pharmacology in Development of CNS Therapies. Failure Analysis of Dimebon in Alzheimer's Diseases
  Hugo Gerts, InSilico Biosciences
Pages: 1 Size: 1733 Kb 
FDA Poster Winner
tweet!  JANUS CTR Data and Cross Study Analysis at FDA
  Helena Sviglin, FDA; Iffat Chowdhury, FDA; Bobbie Witczak, FDA
Pages: 1 Size: 332 Kb 
tweet!  FDA/CBER Biological Product Pharmacological Classification
  Jack Zhang, FDA; Vada Perkins, FDA; Bill Hess, FDA
Pages: 16 Size: 1094 Kb 
tweet!  EZ-R4Excel: How to do Powerful Data Analysis Easily in an EXCEL Environment
  Jyotsna Kasturi, Janssen Pharmaceuticals; Davit Sargsyan, Janssen Pharmaceuticals; Dhamm ika Amaratunga, Janssen Pharmaceuticals
Pages: 1 Size: 3209 Kb 
tweet!  Get Involved with the FDA/PhUSE Script Repository
  Kevin Kanem, Phastar; Hanming Tu, Accenture; Mary Nilsson, Lilly
Pages: 1 Size: 2660 Kb 
tweet!  MetaWise: Extraction and Normalisation of Toxicologic Pathology Terminology From the INHAND Project
  Jennifer Feldman, Instem
Pages: 1 Size: 2065 Kb 
tweet!  MAED Service: FDA Developed Tool for Clinical AE Data Signal Detection
  Joy Li, FDA; Chuck Cooper, FDA; Zhongjun Luo, FDA
Pages: 1 Size: 1487 Kb 
tweet!  Automation of ADaM Dataset Creation with a Prospective, Retrospective and Pragmatic Process
  Karin LaPann, PRA International; Terek Peterson, PRA International
Pages: 1 Size: 628 Kb 
tweet!  Interconnectivity of Nonclinical Data Across Data Silos for Drug Discovery and Development
  Jyotsna Kasturi, Janssen Pharmaceuticals; Paul Brown, CDER FDA; Suresh Madhaven, PointCross Life Sciences; Alan Brown, Instem; Donna Danduone, Instem; Jemery Wally, FDA; Latha Prabakar, PointCRoss Life Sciences
Pages: 1 Size: 1861 Kb 
tweet!  Study Data Reviewers Guide Template Sample
  David Brega, PharmaStat; John Brega, PharmaStat
Pages: 1 Size: 3836 Kb 
tweet!  Fitting Data from Observational Studies to the SDTM
  Jane Diefenbach, PharmaStat
Pages: 1 Size: 437 Kb 
tweet!  Use Case Scenarios for Interorganizational Assembly and Exchange of CDISC SEND Datasets
  Lynda Sands, GlaxoSmithKline; Shree Nath, PointCross Life Sciences; William Houser, Bristol Myers Squibb; Debra Oetzman, Covance Laboratories Inc; Kathryn Brown, Sanofi US Inc; Susan DeHaven, Sanofi US Inc; Jeff Foy, Celgene; Troy Smyrnios, MPI Research; Peggy Zorn, INDS Inc; Jyotsna Kasturi, Janssen Pharmaceuticals
Pages: 1 Size: 1075 Kb 
tweet!  Integrating and Converting Data Across Studies – IDBs
  Natalie Reynolds, Eli Lilly and Company
Pages: 1 Size: 262 Kb 
tweet!  Priorities for a Nonclinical Standardization Roadmap
  Debra Oetzman, Covance Laboratories Inc; Lynda Sands, GlaxoSmithKline; Bob Dorsam, FDA; Gitte Frausing, Novo Nordisk; Rick Thompson, Janssen R&D; Sara Obbers, Janssen R&D; Anisa Scott, JMP Life Sciences; Lou Ann Kramer, Eli Lilly
Pages: 1 Size: 318 Kb 
tweet!  Analytical Overview of the CDER Risk-based GCP Clinical Investigator Inspections Site Selection Tool
  Paul Wesili, FDA
Pages: 1 Size: 1672 Kb 
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