PHUSE2020ConnectUS · VirtualRegulatory Environment
Real-time Oncology Review – Applicant Experience
Paper SA01
Community reference directory
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.
Official links only—files are not hosted by ClinStandards.
Showing 3376–3400 of 5,390 papers
Open official paper
PHUSE2020ConnectUS · VirtualRegulatory Environment
The Misery of the Miscellaneous Folder in Module 5
Paper SA02
PHUSE2020ConnectUS · VirtualRegulatory Environment
Data Standards Used for Electronic Submission of Real-world Evidence in New Drug Applications (NDAs)
Paper SA03
PHUSE2020ConnectUS · VirtualRegulatory Environment
FDA Study Data Guidance Update
Paper SA04
PHUSE2020ConnectUS · VirtualRegulatory Environment
Getting It Right: Refinement of SEND Validation Rules
Paper SA05
PHUSE2020ConnectUS · VirtualRegulatory Environment
A Case Study: Data Transparency of Clinical Trial Data
Paper SA06
PHUSE2020ConnectUS · VirtualRegulatory Environment
Regulatory Scrutiny on Data Integrity: Are You Safe?
Paper SA07
PHUSE2020ConnectUS · VirtualRegulatory Environment
An Update on CDISC-SEND Data Submissions to the FDA
Paper SA08
PHUSE2020ConnectUS · VirtualRegulatory Environment
The JumpStart Traceability Assessment
Paper SA09
PHUSE2020ConnectUS · VirtualRegulatory Environment
Developing SEND for CBER – Collaborative Workstream Initiative Update
Paper SA10
PHUSE2020ConnectUS · VirtualRegulatory Environment
Programmatic Generation of Health Canada's Comparative Bioavailability Information Appendix B
Paper SA11
PHUSE2020ConnectUS · VirtualRegulatory Environment
Managing Simultaneous Drug Submissions with Breakthrough Designations – Lessons Learned from a Programming Perspective
Paper SA12
PHUSE2020ConnectUS · VirtualRegulatory Environment
Getting Closer to Multi-regional Clinical Trials
Paper SA13
PHUSE2020ConnectUS · VirtualRegulatory Environment
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities
Paper SA14
PHUSE2020ConnectEU · VirtualTechnology & Applications
Breaking Boundaries: Working Across Different Workspaces in LSAF
Paper AD09
PHUSE2020ConnectEU · VirtualTechnology & Applications
R Shiny for Exploratory Analysis of Phase III Trial Results
Paper AD16
PHUSE2020ConnectUS · VirtualTechnology & Applications
SPA – A Catalyst for Clinical Protocol Development
Paper SD02
PHUSE2020ConnectUS · VirtualTechnology & Applications
CDISC Library Try-out: From Implementation to Evaluation of the API
Paper SD05
PHUSE2020ConnectUS · VirtualTechnology & Applications
Regulatory Report Automation with R
Paper SD09
PHUSE2020ConnectUS · VirtualTechnology & Applications
Analysis Studio: A Tool Framework for Supporting Regulatory Review
Paper SD10
PHUSE2020ConnectUS · VirtualTechnology & Applications
Quarterly Safety Reporting: Timely Analysis of Clinical Safety Data Using Qlik Sense Software
Paper SD11
PHUSE2020ConnectUS · VirtualTechnology & Applications
Big Data Analytics with JuliaDB
Paper SD12
PHUSE2020ConnectUS · VirtualTechnology & Applications
Life Science's Process Automation of Systems and Solutions
Paper SD14
PHUSE2020ConnectUS · VirtualTechnology & Applications
Using Graph Technology for Metadata-driven Clinical Development
Paper TT01
PHUSE2020ConnectUS · VirtualTechnology & Applications
Digitalization of Clinical Study Report (CSR) Tables and Listings for Cross-report Verification
Paper TT02