THE COMMUNITY ARCHIVE

PHUSE 2025 Papers ArchivePage 4

Browse indexed publications from PHUSE in 2025. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.

438 papers · Showing 121–160

PHUSE · 2025Paper DH03PHUSE US Connect 2025

Enhancing Clinical Trial Data Queries with LLMs and Neo4j: A Flexible Framework for ADaM Dataset Management

Changhong Shi; Jaime Yan

Source category: Data Handling & Engineering

Author collections: Changhong Shi · Jaime Yan

PHUSE · 2025Paper AD07PHUSE EU Connect 2025

Enhancing Clinical Trial Management with Automated Data Integration and Real-Time Analytics

Emmy Pahmer; Katrijn Op De Beeck

Source category: Application Development (AD)

Author collections: Emmy Pahmer

PHUSE · 2025Paper DH07PHUSE US Connect 2025

Enhancing Data Accuracy and Collaboration Through Efficient Data Reconciliation Using SAS in Clinical Trials

Piyush Makkapati; Swathi Nattam

Source category: Data Handling & Engineering

Author collections: Piyush Makkapati · Swathi Nattam

PHUSE · 2025Paper SD10PHUSE US Connect 2025

Enhancing Data Science with Multilingual Capabilities: A Comprehensive GxP-Compliant Solution

Eli Miller; Casey Higgins

Source category: Software Demonstrations

Author collections: Eli Miller · Casey Higgins

PHUSE · 2025Paper PP01PHUSE EU Connect 2025

Enhancing Healthcare Intelligence: Advancing Clinical Information Extraction through Knowledge Graph Construction​

Maria Puri; George Panagiotakis

Source category: Poster Presentations (PP)

Author collections: Maria Puri · George Panagiotakis

PHUSE · 2025Paper ML05PHUSE US Connect 2025

Enhancing Pharmaceutical Quality Assurance Through Large Language Models: A Novel Approach to Intelligent Regulatory Monitoring

Jake Gagnon; Hangyu (Cedric) Liu

Source category: Machine Learning, AI and Large Language Models

PHUSE · 2025Paper CT08PHUSE EU Connect 2025

Enhancing Stats Programming Efficiency in Pharma: Harnessing Large Language Models (LLMs) such as ChatGPT for Accelerated Development and Validation

Andy Ratcliffe

Source category: Coding Tips & Tricks (CT)

Author collections: Andy Ratcliffe

PHUSE · 2025Paper ET06PHUSE US Connect 2025

Enhancing the (ASAP) Aggregate Safety Assessment Planning Framework with an Interactive R Markdown Application: Seeing is Believing!

Debopriya Ghosh; Robert Gordon

Source category: Emerging Trends

Author collections: Debopriya Ghosh

PHUSE · 2025Paper RE04PHUSE EU Connect 2025

Enhancing the Validation and Simulation of Real-World Multi-Site Data with R

Nikolay Trankov; Elena Chaparova

Source category: Real-world Evidence (RE)

PHUSE · 2025Paper DH12PHUSE US Connect 2025

Ensuring Data Integrity: A Three-Step Approach to Clinical Dashboard Validation

River Meckstroth; Kris Wenzel

Source category: Data Handling & Engineering

Author collections: Kris Wenzel

PHUSE · 2025Paper ET23PHUSE US Connect 2025

eProtocol and the Promise of Automation

Bill Qubeck; Suhas Giriraj

Source category: Emerging Trends

Author collections: Bill Qubeck · Suhas Giriraj

PHUSE · 2025Paper PM06PHUSE EU Connect 2025

Essential Conflict Management Tools for Emerging Leaders: From Tension to Transformation

Satish Shetty; Nalin Gupta

Source category: People Leadership & Management (PM)

Author collections: Satish Shetty · Nalin Gupta

PHUSE · 2025Paper PP03PHUSE EU Connect 2025

Evaluating the Use of Real-World Data (RWD) as a Synthetic Control Group: A Statistical Approach

Vasiliki Economou; Dimitrios Kounelis

Source category: Poster Presentations (PP)

PHUSE · 2025Paper PP15PHUSE US Connect 2025

Evaluation of Open-Source Technologies in Clinical Trial Reporting

Jaimin Patel

Source category: Poster Presentations

Author collections: Jaimin Patel

PHUSE · 2025Paper ML15PHUSE EU Connect 2025

Everyday AI for Statistical Programmers: Global Implementation of a Clinical Analysis Assistant

Mathieu Cayssol; Christoph Centner

Source category: Machine Learning, AI & Large Language Models (ML)

Author collections: Mathieu Cayssol

PHUSE · 2025Paper DS11PHUSE US Connect 2025

Evolution of Genomic Data Mapping from PF to GF in SDTM v3.4: Concepts, Challenges and Controlled Terminology with Genetic Variation Examples

Rama Kudaravalli

Source category: Data Standards & Governance

Author collections: Rama Kudaravalli

PHUSE · 2025Paper PP21PHUSE US Connect 2025

Expediting the Regulatory Submission Process Through Automated Tools

Manish Deole; Gautham Selvaraj

Source category: Poster Presentations

Author collections: Manish Deole · Gautham Selvaraj

PHUSE · 2025Paper AS08PHUSE US Connect 2025

FAIR Data, Clear Insights: Enhanced PRO Analysis

Peiqing Yu; Fangming Liao

Source category: Analytics & Statistics

PHUSE · 2025Paper DH06PHUSE EU Connect 2025

FAIRchive Cloud-Based and GxP-Compliant Long-Term Archiving for Clinical Trial Data

Frank Stoinski; Alexander Lüders

Source category: Data Handling & Data Engineering (DH)

Author collections: Alexander Lüders

PHUSE · 2025Paper RE02PHUSE EU Connect 2025

FHIR for RWD Submissions: Why a US Regulation Signals a Global Shift And What You Need To Do Now

Sanyogeeta Andhale; Nachiket Thakkar

Source category: Real-world Evidence (RE)

Author collections: Sanyogeeta Andhale

PHUSE · 2025Paper PP06PHUSE US Connect 2025

Fit for Purpose: How to Prepare a Package for Efficient Data Monitoring Committee (DMC) Data Review

Ke Xiao; Hong Wang

Source category: Poster Presentations

Author collections: Ke Xiao · Hong Wang

PHUSE · 2025Paper AS01PHUSE EU Connect 2025

Fit-For-Purpose Approach of RBQM in Small Clinical Trials

Alicja Mark; Agnes Verhoeven

Source category: Analytics & Statistics (AS)

Author collections: Agnes Verhoeven

PHUSE · 2025Paper CT05PHUSE EU Connect 2025

Floating Points Are as Easy as 01, 10, 11!

Chloe Floodgate

Source category: Coding Tips & Tricks (CT)

PHUSE · 2025Paper DH04PHUSE EU Connect 2025

Framework for Integrating Omics Data with Other Clinical and NonClinical Data Sources

Mehdi Harek; Jonathon Keeney

Source category: Data Handling & Data Engineering (DH)

PHUSE · 2025Paper SA05PHUSE US Connect 2025

From Application to Approval: Exploring the FDA’s Review Process

Kiran Bonda

Source category: Submissions & Agencies

PHUSE · 2025Paper ML12PHUSE EU Connect 2025

From Breaking Bad to Breaking Data: Unlocking TFL PDFs

Andras Kasa; Darius Tetsa

Source category: Machine Learning, AI & Large Language Models (ML)

Author collections: Andras Kasa

PHUSE · 2025Paper PD07PHUSE US Connect 2025

From Data Manager to Data Scientist: Navigating the Future of Data Management in Clinical Trials

Debra Anderson

Source category: Professional Development

PHUSE · 2025Paper PD04PHUSE US Connect 2025

From Fragmentation to Fusion: A Journey Through Mergers and Acquisition Data Integration Challenges

Wenjian Xu; Xiao Huang

Source category: Professional Development

Author collections: Xiao Huang

PHUSE · 2025Paper OS12PHUSE US Connect 2025

From Frozen to Fluid: How the {slushy} R Package Meets the Unique Needs of Study Teams

Becca Krouse

Source category: OS

Author collections: Becca Krouse

PHUSE · 2025Paper ET16PHUSE US Connect 2025

From Manual to Machine: Leveraging Best-of-Breed Approaches in Clinical Data Management

Christina Dinger; Joe Lebers

Source category: Emerging Trends

Author collections: Christina Dinger · Joe Lebers

PHUSE · 2025Paper TT07PHUSE EU Connect 2025

From Mock to Output: Using Generative AI to Write SAS Code for Standards-Based TFLs

Kala Shivali; Bhuvana Venkatappa

Source category: Trends & Technology (TT)

Author collections: Kala Shivali

PHUSE · 2025Paper SA04PHUSE EU Connect 2025

From Outsourced to Open Source: Denalis R-Driven Transformation in Biometrics

Michael Thorpe; Thomas Neitmann

Source category: Submissions & Agencies (SA)

Author collections: Thomas Neitmann

PHUSE · 2025Paper PD06PHUSE EU Connect 2025

From Overload to Insight: Personal Knowledge Management for Clinical Data Scientists in the Age of Generative AI

Sascha Ahrweiler

Source category: Professional Development (PD)

Author collections: Sascha Ahrweiler

PHUSE · 2025Paper ML11PHUSE US Connect 2025

From RAGS to Riches: Creating a CDISC Standard Customer Service Agent Using R and Generative AI

Daniel Woodie

Source category: Machine Learning, AI and Large Language Models

Author collections: Daniel Woodie

PHUSE · 2025Paper RE09PHUSE US Connect 2025

From Roadblocks to Roadmaps: Overcoming Challenges in Registry Data Reporting

Sivasankar Konda; Neha Srivastava

Source category: Real-world Evidence

Author collections: Sivasankar Konda · Neha Srivastava

PHUSE · 2025Paper ML08PHUSE EU Connect 2025

From Schedules of Activities (SoAs) to USDM: Automating Protocol Extraction Using Large Language Models

Kerstin Forsberg; Johannes Ulander

Source category: Machine Learning, AI & Large Language Models (ML)

Author collections: Kerstin Forsberg · Johannes Ulander

PHUSE · 2025Paper TT06PHUSE EU Connect 2025

From SDTM to a Graph-Based, Multi-Purpose Interface for Data

Eva Kelty; Catharina Dahlbo

Source category: Trends & Technology (TT)

Author collections: Eva Kelty · Catharina Dahlbo

PHUSE · 2025Paper ET19PHUSE US Connect 2025

From Specification to CSRs – Towards a Unified Analysis and Review Platform

Steve Ross; Achinoam Ravet-Parel

Source category: Emerging Trends

Author collections: Steve Ross · Achinoam Ravet-Parel

PHUSE · 2025Paper SI02PHUSE EU Connect 2025

From Standards to Strategy: Customising CDISC Open Rules for the TMF Reference Model

Irina Sargsyan; Sabine Jonas

Source category: Standards Implementation (SI)

Author collections: Irina Sargsyan

PHUSE · 2025Paper TT10PHUSE EU Connect 2025

From Static Archives to Analysis Results Standards Maximising the Utility of Statistical Analyses

Ilan Carmeli; Achinoam Ravet Perel

Source category: Trends & Technology (TT)

Author collections: Ilan Carmeli