PHUSE Papers Archive

‘Growth Grows’ Too – in the Professional World! Are We Prepared for the Change?

Charan Kumar Kuyyamudira Janardhana; Anu Sivanesan

Source category: Professional Development

Author collections: Charan Kumar Kuyyamudira Janardhana · Anu Sivanesan

{gsm} Operations – Implementing an Open Central Monitoring Framework

Jenn Krohn

Source category: Risk-Based Quality Monitoring

{tflmetaR}: An R Package to Manage Metadata of Statistical Outputs

Gary Cao

Source category: Open Source Technologies

A Case Study: Biomarker Analysis Using Composite Measure (CM)

Pooja Puniya; Venkata Harish Challa

Source category: Poster Presentations

A Practical Approach to Causal Inference

Sherrine Eid; Laura Watson

Source category: Analytics & Statistics

Author collections: Sherrine Eid · Laura Watson

A Proc Compare Enhancement Macro

Chris Weiner

Source category: Scripts, Macros & Automation

A Skeptics Guide to Using AI for Programming

Frank Menius

Source category: Professional Development

Author collections: Frank Menius

Accelerating Clinical Study Startup: Automated eCRF Generation from Clinical Protocol Documents

Saiteja Nalla; Kedar Deshpande

Source category: Machine Learning, AI & Large Language Models, Data Handling & Data Engineering

Author collections: Kedar Deshpande

Accelerating Iteration in R with Parallel Processing

Sarita Singh

Source category: Coding Tips & Tricks

Accelerating Pharma Innovation: The Role of SAS Synthetic Data

Vivek Salunkhe; Anand Phand

Source category: Emerging Trends & Open Source Technologies

Author collections: Vivek Salunkhe · Anand Phand

Accelerating Productivity: Understand How SAS Viya Copilot Helps Users Work More Effectively Across the Analytics Life Cycle

Ajay Tomar

Source category: Application Development & Software Demonstrations

Accelerating Regulatory Submissions with R: A Scalable and Compliant Approach

Priyanka Sawant

Source category: Emerging Trends & Open Source Technologies

Author collections: Priyanka Sawant

Accelerating Study Build Using AI Enabled CRF Design

Jeremy Zhang; Aimee Basile

Source category: Artificial Intelligence, Machine Learning and Large Language Models

Author collections: Aimee Basile

Accelerating Study Insights: Agile Data Visualisation Using R-Shiny

Lin Yuan; Heather Howell

Source category: Data Visualisations

Acquiring a Compound with Multiple Clinical Trials? Let’s Get Ready for a Type C Meeting! Key Considerations for Preparing Its Regulatory Submission

Mathura Ramanathan; Kajal Tahiliani

Source category: Submissions & Agencies

Author collections: Mathura Ramanathan · Kajal Tahiliani

Across the Multiverse…Statistically Speaking

Trevano Dean; Cralen Davis

Source category: Analytics & Statistics

Author collections: Trevano Dean · Cralen Davis

Adopting gtsummary at Scale: How Roche Built a Companion to gtsummary to Standardise and Simplify ARD-Based Reporting

Daniel Sjoberg

Source category: Open Source Technologies

Author collections: Daniel Sjoberg

Advancing Clinical Programming Through Centres of Excellence

Surendra Yajamanam

Source category: Professional Development

Author collections: Surendra Yajamanam

Advancing Clinical Trial Analysis with Trimmed Means: Estimands, Intercurrent Events and Regulatory Alignment

Prasanth Palanisamy

Source category: Analytics & Statistics & Analytical Risk-Based Monitoring

Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies

Ummul Vara Qurratul Ain

Source category: Analytics & Statistics

Advancing Transparency‑by‑Design in Clinical Trial Disclosure: Real‑World Applications for Regulatory Submissions

Obaraboye Olude; Chantal Din-Bell

Source category: Pavilion

Advancing Transparency, Patient-centricity, and Trustworthiness in Pharma: Metrics and Trends from the Good Pharma Scorecard

Jennifer Miller

Source category: Pavilion

AI + Metadata : An Agentic Approach to Standards-Based Automation

Kevin Burges

Source category: Emerging Trends & Innovation

Author collections: Kevin Burges

AI as Copilot: Empowering, Not Replacing, Statistical Programmers

Bhavesh Patkar; Brian Thornton

Source category: Emerging Trends & Innovation

Author collections: Bhavesh Patkar · Brian Thornton

AI Code Generator: Automating TFL Programming with ARS Metadata

Bhavin Busa; Navin Dedhia

Source category: Software Demonstrations

Author collections: Bhavin Busa · Navin Dedhia

AI for Adverse Event Signal Detection: Moving Beyond Traditional Disproportionality Metrics

Monika Monika

Source category: Machine Learning, AI & Large Language Models, Data Handling & Data Engineering

AI is coming for you: New Biometric Leadership in the era of Agentic AI

Kevin Lee

Source category: Leadership

Author collections: Kevin Lee

AI Reading and Understanding the SAP to Generate the TFL TOC

Siqi (Amber) Wang; Toshio Kimura

Source category: Emerging Trends & Innovation

Author collections: Toshio Kimura

AI Won’t Replace Leaders—But It Will Redefine Them

Chris Decker

Source category: Leadership

Author collections: Chris Decker

AI-Assisted Metadata Programming: A Transparent Framework for PCS in Lab Data Analysis

Donghua Zeng

Source category: Scripts, Macros & Automation

AI-Augmented Bayesian Methods for Late-Onset Toxicity in Early-Phase Trials

Rachana Lele; Arfan Afzal

Source category: Analytics & Statistics

AI-Driven Automation of Statistical Analysis Plans: Leveraging LLMs to Transform Protocol Interpretation

Qingyuan Zhang

Source category: Artificial Intelligence, Machine Learning and Large Language Models

AI-Driven Metadata Integration in Modern TLF Development

Chuck Gelb

Source category: Artificial Intelligence, Machine Learning and Large Language Models

AI-Driven Protocol Review: Accelerating and Simplifying Review

Aditya Moogi

Source category: Poster Presentations

AI-Driven Quality Risk Management for Contract Manufacturing Oversight: An ML Approach

Kiran Kumar Gande

Source category: Risk-Based Quality Monitoring

AI-Driven RBQM: Bridging Operational Excellence and Global Regulatory Demands

Sailesh Bajpai; Hyoback Lee

Source category: Analytics & Statistics & Analytical Risk-Based Monitoring

AI-Optimised AESI Flagging: Streamlined SAS Hash Table Logic with Dynamic CALL EXECUTE and Metadata-Driven Specifications

Hang Zhong; Rashad Rasul

Source category: Scripts, Macros & Automation

Author collections: Rashad Rasul

AI-Powered Approach for Faster, More Efficient Authoring of Clinical and Regulatory Documents

Abhijeet Arora; Inderjeet Arora

Source category: Emerging Trends & Innovation

Author collections: Abhijeet Arora · Inderjeet Arora

AI-Powered Multiple-Agent Pipeline for Automating ADaM Dataset Generation

Bo Ci

Source category: Artificial Intelligence, Machine Learning and Large Language Models

Author collections: Bo Ci

AI-Powered Precision: Transforming Limb Salvage Decisions in Diabetic Foot Syndrome

Kumar Sambhav

Source category: Real-world Evidence & Data Visualisation