PHUSE2026·Connect·Industry Standards
Not Another Other: Bridging Data Collection with SDTM Mapping Without Open Text Fields DS10 US · Austin
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Conference Papers
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PHUSE2026·Connect·Industry Standards
Enabling Innovation: Lessons from the CDISC AI Innovation Challenge DS11 US · Austin
PHUSE2026·Connect·Industry Standards
Standardising Exposure-Response Data for Modelling and Simulation Using CDISC Principles and {admiral} DS12 US · Austin
PHUSE2026·Connect·Industry Standards
Multiple Sclerosis Trials Unpacked: Standards, Endpoints and Programming Experience DS14 US · Austin
PHUSE2026·Connect·Industry Standards
SDTM Automation: Implementation, Rollout and Lessons Learnt DS16 US · Austin
PHUSE2026·Connect·Industry Standards
CDISC Biomedical Concepts for Breast Cancer: A CDISC 360i Perspective DS17 US · Austin
PHUSE2026·Connect·Industry Standards
Metadata-Driven TFL Generation: End-to-End Automation from Protocol to Output DS18 US · Austin
PHUSE2026·Connect·Industry Standards
From System Exports to Standards: Will Standardisation of External Vendor Data Redefine Clinical Data Management/Analysis? DS19 US · Austin
PHUSE2026·Connect·Industry Standards
Transforming Legacy Data into CDISC Standards: Practical Approaches and Regulatory Insights DS20 US · Austin
PHUSE2026·Connect·Industry Standards
Optimising Trial Design Dataset Creation To Minimise P21 Compliance Issues DS22 US · Austin
PHUSE2026·Connect·Industry Standards
From Data to Dossier: Lessons from Cross-Company Regulatory Submissions SA01 US · Austin
PHUSE2026·Connect·Industry Standards
Breaking Free from the xpt: Exploration of Dataset-JSON as an Alternative Transport File to Regulatory Agencies SA02 US · Austin
PHUSE2026·Connect·Industry Standards
Acquiring a Compound with Multiple Clinical Trials? Let’s Get Ready for a Type C Meeting! Key Considerations for Preparing Its Regulatory Submission SA03 US · Austin
PHUSE2026·Connect·Industry Standards
Trends in eSub Evaluation Findings: A Twenty-Year Perspective on Data Traceability SA04 US · Austin
PHUSE2026·Connect·Industry Standards
Electronic Submission of Population PK Analysis Files… What’s Your Modus Operandi? SA05 US · Austin
PHUSE2026·Connect·Industry Standards
Common Issues in BIMO Clinical Site Dataset Packages SA07 US · Austin
PHUSE2026·Connect·Industry Standards
Key Guidelines, Tricks and Experiences for the PMDA and a Comparison with FDA and NMPA CDE Submissions SA08 US · Austin
PHUSE2026·Connect·Industry Standards
Multi-Standard Submission – Process, Learnings and Recommendations for Best Practice SA09 US · Austin