PharmaSUG2022paper·US·Strategic Implementation
Implementing and Achieving Organizational R Training Objectives SI-055
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PharmaSUG2022paper·US·Strategic Implementation
External R Package Qualification Process in Regulated Environment SI-057
PharmaSUG2022paper·US·Strategic Implementation
Finding Accord: Developing an eCOA Data Transfer Specification (DTS) All Can Agree On. SI-067
PharmaSUG2022paper·US·Strategic Implementation
Ensuring Distributed Data custody on Cloud Platforms SI-097
PharmaSUG2022paper·US·Strategic Implementation
Cyber Resiliency – Computing Platform Modernization SI-099
PharmaSUG2022paper·US·Strategic Implementation
Quality Gates: An Overview from Clinical SAS® Programming Perspective SI-164
PharmaSUG2022paper·US·Strategic Implementation
Vendor Audit: What it is and What to Expect from it SI-168
PharmaSUG2022paper·US·Strategic Implementation
Orchestrating Clinical Sequels with a Strategic Wand – Challenges of introducing Rolling CSRs in a Master Protocol SI-191
PharmaSUG2022paper·US·Submission Standards
Lessons Learned from Using P21 to Create ADaM define.xml with Examples SS-023
PharmaSUG2022paper·US·Submission Standards
FDA Advisory Committee Meetings– A Statistical Programmer’s Survival Guide SS-035
PharmaSUG2022paper·US·Submission Standards
Real Time Oncology Review Readiness from Programming Perspective SS-039
PharmaSUG2022paper·US·Submission Standards
Including Population Information in ADaM define.xml for Better Understanding of Datasets SS-087
PharmaSUG2022paper·US·Submission Standards
A SAS Macro to Support the Supplemental Qualifier Section in cSDRG SS-110
PharmaSUG2022paper·US·Submission Standards
Explanations in the Study Data Reviewer’s Guide: How’s It Going? SS-152
PharmaSUG2022paper·US·Submission Standards
A Standardized Reviewer’s Guide for Clinical Integrated Analysis Data SS-154
PharmaSUG2022paper·US·Submission Standards
A Practical Approach to Preparing Documentation for Clinical Registries SS-158