SA07 Navigating FDA Requirements: ISS/ISE Build Strategies
Source category: Submissions and Agencies
Author collections: Priyank Patel
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PHUSE Papers ArchivePage 73
Browse indexed publications from PHUSE. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.
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3,716 papers · Showing 2881–2920
SA07 The Benefits, Challenges and Myths of SEND
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer
SA08 Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND)
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer
SA09 Impact of SEND Data on FDA Review of Nonclinical Studies
Source category: Submissions & Agencies
Author collections: Kevin Snyder
SA10 Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service
Source category: Submissions & Agencies
Author collections: Jesse Anderson · Christopher Bartlett
SA13 The Clinical Data Specialist Role Within Regulatory Review
Source category: Submissions & Agencies
Author collections: Joy Li
SA15 FDA View: Update on Study Data Submission
Source category: Submissions & Agencies
Author collections: Ethan Chen · Lilliam Rosario
SA17 Streamlining the Results Reporting for ClinicalTrials.gov and EudraCT
Source category: Submissions & Agencies
Author collections: Susruth Ganoothula
SAS Outputs in Excel Workbook Using ODS Excel
Source category: Coding Tips and Tricks
SAS/STAT High-performance Statistics Procedures Contrasted with their Legacy Counterparts
Source category: Analytics and Statistics
SD01 DR3 – A Tool to Create Define-XML (SDTM/ADaM with ARM)
Source category: Software Demonstrations
Author collections: Eric Weising
SD01 Formedix On: Advanced Metadata Management and Data Conversion
Source category: Software Development
Author collections: Kevin Burges
SD02 Mapping Programs – Written by MDR
Source category: Software Demonstrations
Author collections: Jörn Bilow
SD02 R You Ready for Simulo: A User-friendly Clinical Trial Simulator
Source category: Software Development
Author collections: Nicolas Luyckx · Quentin Leirens
SD03 Automated RTF Table Translation – An Illustrated Approach
Source category: Software Development
Author collections: Amit Bhaniani · Qian Wang
SD03 Making the Case for Metadata Development
Source category: Software Demonstrations
Author collections: Mike Molter
SD04 Embrace Real-world Data and Enhance Your Analytics Approaches with SAS’ Open Platform
Source category: Software Development
Author collections: Stijn Rogiers · Sherrine Eid
SD04 Overview of SAS Studio
Source category: Software Demonstrations
SD05 Formedix On: Advanced Metadata Management Now With Data!
Source category: Software Demonstrations
Author collections: Kevin Burges
SD07 Building SQL Scripts Using Google Sheets R and R Shiny
Source category: Software Demonstrations
SD07 Oracle Analytics Cloud
Source category: Software Development
Author collections: Mike Collinson
SD08 Analysis and Reporting Workbench (ARW) Demo
Source category: Software Demonstrations
SD09 Simulo – A User-friendly Platform for Model-based Simulations
Source category: Software Demonstrations
Author collections: Nicolas Luyckx · Quentin Leirens
SD10 Management and Enforcement of Custom Standards and Terminologies with Pinnacle 21 Enterprise
Source category: Software Demonstrations
Author collections: Max Kanevsky
SD11 Managing Complexity Towards Submission
Source category: Software Demonstrations
Author collections: Johannes Ulander
SDTM Validation Tool
Source category: Data Handling
Semi Auto-generated Narratives
Source category: Application Development
SI01 End-to-End SDTM Automation: A Metadata-centric Approach
Source category: Standards Implementation
Author collections: Roman Radelicki · Swapna Pothula
SI01 How Will You Use CDISC Library?
Source category: Standards Implementation
SI02 Creating the Virologic Response ADaM Dataset
Source category: Standards Implementation
SI02 Implementing the CDISC Library API in Software Applications: First Experiences
Source category: Standards Implementation
Author collections: Jozef Aerts
SI03 Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts
Source category: Standards Implementation
Author collections: David Iberson-Hurst
SI04 Creation of Define-XML v2.0 Using SAS Program and Pinnacle 21
Source category: Standards Implementation
SI04 Mapping Raw Data to SDTM Define Using the SAS Clinical Standards Toolkit
Source category: Standards Implementation
SI05 Fake it Till You Make it with Global SDTM Laboratory Submissions
Source category: Standards Implementation
Author collections: Éanna Kiely
SI05 Using Pinnacle 21 Enterprise for Define-XML Creation: Tips and Tricks from a CRO Perspective
Source category: Standards Implementation
Author collections: Franklin Menius
SI06 End-to-end SDTM Automation: A Metadata-centric Approach (winner)
Source category: Standards Implementation
Author collections: Roman Radelicki
SI06 Ensuring Consistent and Supported Standards Across Data and Metadata in a Large Regulatory Filing is Tricky Business
Source category: Standards Implementation
Author collections: Lisa Brooks
SI07 Have You Met Define-XML v2.0?
Source category: Standards Implementation
Author collections: Christine McNichol
SI07 How to Use SUPPQUAL for Specifying Natural Key Variables in Define-XML?
Source category: Standards Implementation
Author collections: Sergiy Sirichenko