PharmaSUG2018paper·US·Submission StandardsProgrammer’s Guide for OSI Deliverables – Creation of Site Level Summary Dataset and Automation of BIMO Listins Generation SS16See metadata
PharmaSUG2018paper·US·Submission StandardsWhy organizations need MDR systems to manage metadata? SS17See metadata
PharmaSUG2018paper·US·Submission StandardsWant Submission-Ready Datasets Package from the Get-Go? SS19See metadata
PharmaSUG2018paper·US·Submission StandardsReview programs used for submission and their input to the define-XML 2.0 SS20See metadata
PharmaSUG2018paper·US·Submission StandardsWatch Out For Blind Spots While Keeping Up With the Speed of Evolving Standards and Regulations SS22See metadata
PharmaSUG2018paper·US·ePostersApplication of Survival Analysis in Multiple Events Using SAS EP02See metadata
PharmaSUG2018paper·US·ePostersLink Up Sync Up: Calculation of concordance and discordance rates between Independent Review Facility (IRF) and Investigator site data using SAS® EP03See metadata
PharmaSUG2018paper·US·ePostersImplementing the Rank-Preserving Structural Failure Time Model in SAS and R EP04See metadata
PharmaSUG2018paper·US·ePostersLet’s Get FREQy with our Statistics: Data Driven Approach to Determining Appropriate Test Statistic EP09See metadata
PharmaSUG2018paper·US·ePostersSome Common Programming Errors and Possible Solutions That Could Impact a Successful NDA/BLA EP10See metadata
PharmaSUG2018paper·US·ePostersA SAS Macro Application on Confidence Intervals for Binominal Proportion EP12See metadata
PharmaSUG2018paper·US·ePostersPreparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA EP15See metadata
PharmaSUG2018paper·US·ePostersCreating and Customizing Graphics using Graph Template Language EP17See metadata
PharmaSUG2018paper·US·ePostersUseful Adverse Events (AE) data Diagnostics and Summarization EP19See metadata