PharmaSUG2021paper·US·Strategic ImplementationA Strategy to Develop Specification for R Functions in Regulated Clinical Trial Environments SI-074See metadata
PharmaSUG2021paper·US·Strategic ImplementationThe Search for a Statistical Computing Platform SI-076See metadata
PharmaSUG2021paper·US·Strategic ImplementationAgile Project Management in Analysis and Reporting of Late Stage Clinical Trial SI-083See metadata
PharmaSUG2021paper·US·Strategic ImplementationA Process to Validate Internal Developed R Package under Regulatory Environment SI-084See metadata
PharmaSUG2021paper·US·Strategic ImplementationBookdown and Blogdown: Using R packages to document and communicate new processes to Clinical Programming SI-108See metadata
PharmaSUG2021paper·US·Strategic ImplementationDelight the Customer using agile transformation in Clinical Research SI-166See metadata
PharmaSUG2021paper·US·Strategic ImplementationThe Tortoise and the Hare – Lessons Learned in Developing ADaM Training SI-173See metadata
PharmaSUG2021paper·US·Strategic ImplementationChasing Master Data Interoperability: Facilitating Master Data Management (MDM) Through CSV Control Tables that Contain Data Rules that Support SAS and Python Data-Driven Software Design SI-196See metadata
PharmaSUG2021paper·US·Strategic ImplementationR Validation: Approaches and Considerations SI-203See metadata
PharmaSUG2021paper·US·Strategic ImplementationManage TFLs Development in LSAF 5.3 using SAS and R code SI-213See metadata
PharmaSUG2021paper·US·Submission StandardsDesign ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML in CDISC Era SS-016See metadata
PharmaSUG2021paper·US·Submission StandardsShiny App for Generating Data Dependency Flowchart in ADRG SS-058See metadata
PharmaSUG2021paper·US·Submission StandardsChallenges and Solutions for an ISM Development SS-072See metadata
PharmaSUG2021paper·US·Submission StandardsNew Requirements of Clinical Trial Data Submission for China Filing: An Implementation SS-073See metadata
PharmaSUG2021paper·US·Submission StandardsAssembling Reviewer-friendly eSubmission Packages SS-110See metadata
PharmaSUG2021paper·US·Submission StandardsEffective Approach for ADaM Submission to FDA and PMDA SS-137See metadata
PharmaSUG2021paper·US·Submission StandardsA Lead Programmer’s Guide to a Successful Submission SS-171See metadata
PharmaSUG2021paper·US·ePostersMigration of SAS Data from Unix server to Linux server EP-004See metadata
PharmaSUG2021paper·US·ePostersReduce Review Time: Using VB to Catch Spelling Errors & Blank Pages in TLFs EP-013See metadata