Mapping OMAP Data to SDTM – Use Case for RWD in CAR-T Registry Studies
Source category: Real-world Evidence
Author collections: Joe Xi
THE COMMUNITY ARCHIVE
PHUSE 2025 Papers ArchivePage 7
Browse indexed publications from PHUSE in 2025. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.
438 papers · Showing 241–280
May the Code Be with You: Entering the pharmaverse Galaxy
Source category: Open Source Technologies (OS)
Author collections: Kirsty Lauderdale
Measure Total Steroid Dose Using Real-World Data
Source category: Poster Presentations
Author collections: Yi-Chien Lee
Metaprogramming in R
Source category: Emerging Trends
Author collections: Sudhir Kedare · Rajprakash Chennamaneni
Micro-Decisions, Macro Impact: The Role of Agile Thinking in Every Line of Code
Source category: Coding Tips & Tricks (CT)
Author collections: Eswara Satyanarayana Gunisetti
Milestones Matter: Understanding Key Milestones in Clinical Trials
Source category: Poster Presentations (PP)
Author collections: Satyapal Gudla
Mind the Gap: Imputing Missing Dosing Times in QD & BID Regimens Using ADPPK Guidelines
Source category: Data Handling & Data Engineering (DH)
Author collections: Aschwin van der Giesen · Gerly van der Vleuten
Modernising Clinical Data Science: Best Practices for a Unified, Governed SCE
Source category: Application Development (AD)
Author collections: Matthew Tendler
More Than a p-Value: Understanding the Differences Between Clinical and Statistical Significance
Source category: Analytics & Statistics
Author collections: Jasperlynn Kao · Elnaz Ghadimi
Multiple Imputation in Composite Endpoints – It’s Not That Hard!
Source category: Analytics & Statistics
Author collections: Ashley Mao
Multiple Imputations Overview of Missing Data Problem, Solution Methods and SAS Implementation
Source category: Analytics & Statistics (AS)
Natural Language to Code: AI-Powered Automation for CDISC-Compliant Datasets
Source category: Machine Learning, AI and Large Language Models
Author collections: Vina Ro
Navigating Anonymous Employee Feedback: A Managers Guide to Constructive Action
Source category: People Leadership & Management (PM)
Author collections: Lynn Clipstone
Navigating Experimental Arms in Subtype Studies: Strategies for Precision and Clarity
Source category: Analytics & Statistics (AS)
Author collections: Narek Torosyan
Navigating the Complexities of AESI: A Centralised Approach to Molecule-Level Management
Source category: Data Standards & Governance
Navigating the Transition to a New Statistical Computing Environment: Streamlining Compliance and Operational Excellence
Source category: Poster Presentations
Author collections: Shilpa Sood · Kala Shivalingaiah
Neither Magic Wand Nor Terminator: Finding the Sweet Spot in AI-Assisted Coding
Source category: Machine Learning, AI & Large Language Models (ML)
Author collections: Josua Böser
Neurodiverse Teams: Fostering Innovation and Inclusion
Source category: Professional Development
Author collections: Laura Needleman
Neurodriven Mentorship: Recognising and Teaching Different Kinds of Thinkers
Source category: People Leadership & Management (PM)
Author collections: Arman Melkonyan
New Multiple Imputation Approaches with SAS
Source category: Analytics & Statistics (AS)
Author collections: Andrea Parodi
Next-Generation Deliverable Tracker
Source category: Software Demonstrations
Author collections: Michael Byrne · Stuart Malcolm
No Patients? No Problem Define Your Study Data with Python at the CORE
Source category: Application Development (AD)
Author collections: John McDade
ODS Management of Regulatory Referenced Deliverables Workshop
Source category: Regulatory Environment
Author collections: Christine Rossin · Randi McFarland
Oh Dear, Another Crisis? A Programmers Guide to Surviving and Thriving Through the FDA ODAC
Source category: Submissions & Agencies (SA)
Author collections: Zach Dorman
One-Sample Log-Rank Test for One Sample Survival Studies: SAS Code vs R Code
Source category: Coding Tips & Tricks (CT)
Author collections: Simona Scartoni
Open-Source Practicalities and the Legal Side
Source category: Open Source Technologies (OS)
OpenRBQM Extended: Endpoint Monitoring, Root Cause Analysis and Workflows
Source category: Analytics Risk-based Monitoring
Author collections: Spencer Childress · Jeremy Wildfire
Optimising AI Software for Automated Protection of Personal and Commercially Sensitive Data
Source category: Poster Presentations
Author collections: Honz Slipka
Optimising Collaboration and Quality Control in Outsourced Statistical Programming
Source category: Professional Development
Author collections: Nileshkumar Patel
Optimising Leadership Strategies for Global Teams Through Time Zone-Based Task Assignment
Source category: Professional Development
Author collections: Tigran Alikhanyan
Optimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI
Source category: Submissions & Agencies
Author collections: Kishore Pothuri
Optimising SDTM and ADaM: Remediation Techniques for Data Accuracy
Source category: Data Standards & Governance
Author collections: Kishore Pothuri
Optimising the Development and Regulatory Submission of an eSUB Package for Exposure-Response and PK/PD Analysis
Source category: Submissions & Agencies
Author collections: Saumil Tripathi
Our Journey in Integrating External Control Arms (ECAs) and Real-World Data (RWD) for Rare Disease Trials
Source category: Poster Presentations (PP)
Author collections: Gautham Selvaraj
Overcoming Challenges in Collaborative Spreadsheet Editing with Shiny, SpreadJS and JSON-Patch
Source category: Application Development (AD)
Author collections: Sebastià Barceló
Oversight of Vendor Deliverables: A Layered Approach to Enable Consistent and Automated Oversight and Minimise the Risk of Overlooking Critical Issues
Source category: Poster Presentations (PP)
Author collections: Pramod Chittam
Pharmacokinetics Is Simple... Sometimes
Source category: Data Handling & Data Engineering (DH)
PHUSE in Japan: Past, Present and Future
Source category: Poster Presentations
PHUSE Working Groups 2024 Highlights
Source category: Poster Presentations
Author collections: Chris Price
PHUSE Working Groups Highlights
Source category: Poster Presentations (PP)
Author collections: Chris Price