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33 papers and 4 presentations; 33 titles.

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Conference × Year × Title × Authors Extras Pages
PHUSE US 2026 Electronic Clinical Data Submissions Across Global Regulatory Authorities Sampath Madanu source
presentation source
12
PHUSE US 2026 Submitting RWD: Where We Are and Where We Are Going Ingeborg Holt,
Sarah Ferko,
Jeffrey M. Abolafia
source
presentation source
24
PHUSE EU 2024 Coral Reef- A FAIR metadata layer to provide clinical study data at your fingertips Javier D. Fernández,
Nelia Lasierra
source
presentation source
5
SESUG 2024 Data Access Made Easy Using SAS Studio Kirk Paul Lafler,
Shaonan Wang,
Nuoer Lu,
Zheyuan (Walter) Yu,
Daniel Qian,
Swallow Xiaozhe Yan
source 26
SESUG 2024 Generating new variables from variable names and values in a DATA step Bruce F. Gilsen source 11
WUSS 2023 Data Access Made Easy Using SAS Studio Kirk Paul Lafler,
Shaonan Wang,
Nuoer Lu,
Zheyuan (Walter) Yu,
Daniel Qian,
Swallow Xiaozhe Yan
source 26
SESUG 2023 Data Access Made Easy Using SAS Studio Kirk Paul Lafler,
Shaonan Wang,
Nuoer Lu,
Zheyuan (Walter) Yu,
Daniel Qian
source 26
PharmaSUG 2023 Data Access Made Easy Using SAS Studio Kirk Paul Lafler,
Shaonan Wang,
Nuoer Lu,
Zheyuan (Walter) Yu,
Daniel Qian
source 26
PharmaSUG 2023 Hard Coding: What is it? Why Does It Matter? What Should You Do When Faced With Such A Request? Michael Nessly source 4
PHUSE US 2023 CDISC CORE - Milestones, Status and Roadmap Peter Van Reusel source
presentation source
9
SESUG 2022 Enhancing Your Skillset with SAS OnDemand for Academics (ODA) Software Kirk Paul Lafler source 30
WUSS 2022 Data Access Made Easy Using SAS Studio Kirk Paul Lafler,
Zheyuan Yu,
Shaonan Wang,
Nuoer Lu,
Daniel Qian,
Swallow Xiaozhe Yan
source 26
PHUSE US 2022 Using AI-based Technology to Accelerate Clinical Trial Data Sharing and Reuse [presentation] Ron Kaine,
Thomasin Element
source
video
33
PHUSE EU 2021 Best Practices: Analysing Classical Clinical Trial Data with ML Methods [presentation] Uwe Pritzsche source
video
10
PharmaSUG 2021 SEND for CBER Lisa Lin source 26
PHUSE EU 2020 Preparing for FDA and PMDA Submission Simultaneously - What to Leverage, How to Deal with the Differences Efficiently [presentation] Jasmine Kestemont source
video
22
PHUSE EU 2019 Validating R functions against SAS outputs: How RTest can build a bridge allowing to validate R Sebastian Wolf source
presentation source
6
PHUSE EU 2018 AstraZeneca Early Clinical Biometrics Journey into Integrated Clinical Data Environment Ruhul Amin,
Per-Arne Stahl
source
presentation source
12
PHUSE EU 2018 Study URI Kerstin Forsberg,
Daniel Goude
source
presentation source
9
PHUSE EU 2018 The MetaDataHub - Integrating, Searching and Presenting Study Descriptive Information Elisabeth Nyman,
Michail Doulis
source
presentation source
8
PharmaSUG 2018 Electronic Data Submission and Utilization in Japan Yuki Ando source 25
PharmaSUG 2017 Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit Lex Jansen source 31
PharmaSUG 2017 Leveraging Centralized Programming Resources Using SAS Integration Technologies Tony Chang source 8
PharmaSUG 2017 Leveraging Study Data Reviewer-s Guide (SDRG) in Building FDA-s Confidence in Sponsor-s Submitted Datasets Xiangchen (Bob) Cui,
Min Chen,
Letan (Cleo) Lin
source 10
PharmaSUG 2016 Creating Define-XML version 2 including Analysis Results Metadata with the SAS Clinical Standards Toolkit Lex Jansen source 29
PHUSE EU 2014 Clinical Study Data Processes @ LEO Pharma Joergen Iversen source
presentation source
4
PHUSE EU 2014 The On-Going Evolutionary Changes of our Industry [presentation] Christian Mueller source 34
PHUSE EU 2013 Standards for the Management of Clinical Trial Data, Why are they Needed, What is Needed? Isabelle Abousahl source
presentation source
11
PHUSE EU 2011 SAS Drug Development as a platform governing data standards specification and clinical data exchange between pharmaceutical organizations Tina Apers source
presentation source
56
PharmaSUG 2010 Accessing and using the metadata from the define.xml Lex Jansen 22
PharmaSUG 2010 Accessing the metadata from the define.xml using XSLT transformations Lex Jansen 70
SGF 2010 Understanding the define.xml File and Converting It to a Relational Database Lex Jansen source 20
WUSS 2009 The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics Fred Wood source 9
PharmaSUG 2009 Converting the define.xml to a Relational Database to Enable Printing and Validation Lex Jansen 18
PharmaSUG 2009 Medical Coding System for Clinical Trials - 21 CFR Part 11 Compliant SAS/AF Application Annie S. Guo 12
PharmaSUG 2009 Understanding the define.xml and converting it to a relational database Lex Jansen 17
WUSS 2004 Using SAS IOM With A Java Client Application Valerie Williams,
Brian Chan
source 12

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