PHUSE2026Data Science
From Oversight to Insight – Rethinking Risk-Based Quality Management
Paper RM01
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Conference Papers
Find papers in official PHUSE, PharmaSUG, and WUSS proceedings. Search by title or paper number, then narrow the directory by conference, year, or category.
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PHUSE2026Data Science
Operationalising ICH E6 R3: A Risk-Based Blueprint for Data Management
Paper RM02
PHUSE2026Data Science
Equity as a Dimension of Quality: Embedding Inclusion into RBQM Oversight Frameworks
Paper RM03
PHUSE2026Data Science
{gsm} Operations – Implementing an Open Central Monitoring Framework
Paper RM04
PHUSE2026Data Science
Scalable R Packages Qualification Using a CI/CD Approach
Paper RM05
PHUSE2026Data Science
AI-Driven Quality Risk Management for Contract Manufacturing Oversight: An ML Approach
Paper RM06
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Embracing the Semantic Shift: SDTMIG 4.0 and the Rise of Intelligent Clinical Data Standards
Paper DS01
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Next-Gen Transport Standards: Dataset-JSON from a Programmer’s Lens
Paper DS02
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Charting New Territory: R-Based Submissions Made Easy
Paper DS03
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
An AI-Powered Digital Standards Library for Accelerated Regulatory Submissions
Paper DS04
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Unified Meta-Study: Harmonising Clinical Biomarker, Genomics and Clinical Trial Data for Enhanced Access, Usability and Life Cycle Management
Paper DS05
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Bridging the Divide: Harmonising HL7 FHIR, OMOP and CDISC Standards for Regulatory-Grade Real-World Evidence
Paper DS07
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Optimising Pinnacle 21 Compliance with Automated Metadata Updates
Paper DS08
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
e2e Metadata-Driven Model for Efficient Reporting – Unveiling a Revolutionary Method for Defining Metadata and Reporting
Paper DS09
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Evolving with SDTMIG v3.4: What Clinical Data Professionals Need To Know
Paper DS11
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Key Programmer Tasks for Japan Submission and Programmer Role Allocation
Paper DS13
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Solving the Fragmentation Challenge in Rheumatoid Arthritis (RA) Trials: Deriving Deeper Insights
Paper DS14
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
Standardisation of Auxiliary Medicinal Products (AxMPs) in Clinical Trials
Paper DS15
PHUSE2026Data Standards, Governance & Implementation & Submissions & Agencies
From XPT to JSON for Submissions: Are We Ready for the Change?
Paper DS16
PHUSE2026Emerging Trends & Open Source Technologies
Unlock Deeper Clinical Insights: A Unified Approach to Data Analysis with SAS, R and Python
Paper ET02
PHUSE2026Emerging Trends & Open Source Technologies
OPS Builder: Navigating the Cosmos of Study Deliverables with Stellar Automation
Paper ET03
PHUSE2026Emerging Trends & Open Source Technologies
Accelerating Pharma Innovation: The Role of SAS Synthetic Data
Paper ET04
PHUSE2026Emerging Trends & Open Source Technologies
Integrating R Programming and Generative AI for Prompt-Driven Clinical Trial Data Analysis
Paper ET05
PHUSE2026Emerging Trends & Open Source Technologies
Leveraging Historical Control Data Through Adaptive Bayesian Hierarchical Models
Paper ET06
PHUSE2026Emerging Trends & Open Source Technologies
Legacy to Leading Edge: Reinventing Biostats Programming with Open Source, AI and Agile Innovation
Paper ET07