PHUSE2019ConnectUS · BaltimoreProgramming Languages
Code Generator to Verify Implementation of Cut-off Date
Paper CT14
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Conference Papers
Find papers in official PHUSE, PharmaSUG, WUSS, SESUG, and MWSUG proceedings. Search by title or paper number, then narrow the directory by conference, event, region, year, or category.
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Showing 3701–3725 of 5,390 papers
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PHUSE2019ConnectUS · BaltimoreProgramming Languages
Implementing Imputation Rules and Creating Analysis Flags Following CDISC Guidelines
Paper CT15
PHUSE2019ConnectUS · BaltimoreProgramming Languages
A Macro Tool to Reduce the Size of the Regulatory Submission Dataset
Paper CT16
PHUSE2019ConnectEU · AmsterdamProgramming Languages
R or Python? Dilemma, Dilemma…
Paper SM01
PHUSE2019ConnectEU · AmsterdamProgramming Languages
Validate the Validated: A Python Tool for Study Leads to Review Clinical Outputs
Paper SM02
PHUSE2019ConnectEU · AmsterdamProgramming Languages
How to Use VBA for CRT: Automating the P21 Community Master Spec
Paper SM03
PHUSE2019ConnectEU · AmsterdamProgramming Languages
SAS Macro Quoting – A Look Behind the Scenes
Paper SM04
PHUSE2019ConnectEU · AmsterdamProgramming Languages
An Efficient Way to Combine RTF Files and Create Multi-level Bookmarks and a Hyperlinked TOC
Paper SM05
PHUSE2019ConnectEU · AmsterdamProgramming Languages
Adapting the SAS Enterprise Guide Log Summary to Check Your LOG for You
Paper SM06
PHUSE2019ConnectEU · AmsterdamProgramming Languages
Automating Validation of Statistical Reports – A Real Case Study
Paper SM07
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
Development of the Standard BIMO Process to Create the Clinsite Dataset
Paper SA01
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing: Synergies and Differences
Paper SA01
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective
Paper SA02
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Machine-readable Data Not Required for the EMA...Really?
Paper SA02
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements
Paper SA03
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
High-quality Study Data Standards for Submission
Paper SA03
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Submission of Software Programs to Regulatory Agencies
Paper SA04
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
Processing Big Data from Multiple Sources
Paper SA04
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Approach of Programming Production Harmonized with Submission
Paper SA05
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
How Metadata Can Help Drive the Creation of Tables, Figures and Listings
Paper SA05
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Developing SEND for CBER – Collaborative Workstream Initiative
Paper SA06
PHUSE2019ConnectEU · AmsterdamRegulatory Environment
Navigating FDA Requirements: ISS/ISE Build Strategies
Paper SA07
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
The Benefits, Challenges and Myths of SEND
Paper SA07
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND)
Paper SA08
PHUSE2019ConnectUS · BaltimoreRegulatory Environment
Impact of SEND Data on FDA Review of Nonclinical Studies
Paper SA09