FDA/PhUSE Annual Computational Science Symposium
Poster Presentations
The Symposium invited individuals to present posters on company achievements and developments within the industry. Twenty one posters were presented in total with five Authors also delivering interactive demonstrations.
Please click on the links below to download the posters:
Preparing Data for Submission to the FDA - It's More Than SDTM - Winning PosterBruce Thompson, C-TASC
An Evaluation of Data Mining Methods and Software for Adverse Events Occurring in Clinical Trials - 1st Runner UpPaul Schuette, FDA
Adaptive Trials and the Impact on STDM Trial Design Model - 2nd Runner UpNate Freimark, Theorem Clinical Research
Path to Metadata-Driven Standards Environment - Collection to Submission Melissa Binz, Novartis Pharmaceuticals Corporation
SAS Template Programs for Building Derived Datasets, Tables and ListingsMichael Carniello, Takeda Global R&D
Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA SubmissionMin Chen, Vertex Pharmaceuticals
Risk Based SDV (Source Data Verification)Shafi Chowdhury, Shafi Consultancy
An Innovative ADaM Programming Tool for FDA SubmissionXiangchen (Bob) Cui
Achieving an 'Error Free' OpenCDISC Report - Realistic or Idealistic?Ratnakar Gundlapalli, ICON Plc
Throwing Data Over the Wall: The Next Big Threat to Clinical Data QualityKit Howard, Kestrel Consultants Inc
The Clinical Data Repository Initiative at Novartis Vaccines and Diagnostics: A RevolutionPantaleo Nacci, Novartis Vaccines and Diagnostics
Nonclinical Safety Data Integration PlatformAlain Nanzer, F.Hoffman-La Roche Ltd
Standardization in Medical Research Data: Improving Data Displays and Data TraceabilityMary Nilsson, Eli Lilly & Company
Describing Data from Capture to Operational Use to CDISC-Compliant SubmissionYun Oldshue, Takeda Global R&D
Using SAS® to Calculate Noncompartmental Urine ParametersVanessa Rubano, Boehringer Ingelheim Pharmaceuticals USA
Automation of Clinical Trial Reporting: From Shells to TFL Outputs Without a Single Line of SAS CodeFrancois Vandenhende, Clinbay
Comparing the Risk-Benefit of SDTM Software SolutionsMichael Wall, Pharstar
Optimizing the Organizational Performance of the Clinical Trials Process Through Better TechnologyMichael Whitworth, Quanticate
CDISC Standards in Reverse: A More Efficient Approach to Clinical Trials DesignRobert Woolson, Rho Inc
Business Process Management (BPM) at the FDA: The Agency's Early Experience in Implementing BPM SW ToolsMarkus Yap, FDA
CDISC-AdvaMed Device Project
Fred Wood, Octagon Research Solutions