THE COMMUNITY ARCHIVE

PHUSE 2025 Papers ArchivePage 8

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

438 papers · Showing 281–320

PHUSE · 2025Paper PP11PHUSE US Connect 2025

Pivoting to AI: Turning Career Transition into Innovation

Rick Stephens

Source category: Poster Presentations

PHUSE · 2025Paper AS04PHUSE US Connect 2025

Planning Ahead: A Novel Approach to Creating Synthetic Immunogenicity Data

Surendra Yajamanam; Ruilan Wei

Source category: Analytics & Statistics

Author collections: Surendra Yajamanam

PHUSE · 2025Paper PP07PHUSE EU Connect 2025

Plunging into Pools: Dive into a Comparative Analysis of Pooled TLFs with R

Sophie Khan

Source category: Poster Presentations (PP)

PHUSE · 2025Paper TT12PHUSE EU Connect 2025

Pooling Studies Through Code Traceability

Hamdi Chouikha; Kornelius Neufeld

Source category: Trends & Technology (TT)

PHUSE · 2025Paper ML07PHUSE EU Connect 2025

Poseidon: Streamlined Regulatory Screening of HA Websites with AI/ML to Extract Updates and Reduce Manual Efforts

Maria Giovanna Zilli; Fabian Wahren

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

PHUSE · 2025Paper OS22PHUSE US Connect 2025

Posit Team: Metadata-Driven Risk Assessment and Surfacing Validated R Packages

Philip Bowsher; Michael Mayer

Source category: OS

Author collections: Philip Bowsher · Michael Mayer

PHUSE · 2025Paper ET20PHUSE US Connect 2025

Positron: Overview for Pharma

Philip Bowsher; Cole Arendt

Source category: Emerging Trends

Author collections: Philip Bowsher · Cole Arendt

PHUSE · 2025Paper TT03PHUSE EU Connect 2025

Powering Up Programming Milestones: From Chaos to Cohesion

Maciej Wysokiński; Hitesh Thacker

Source category: Trends & Technology (TT)

PHUSE · 2025Paper PP16PHUSE US Connect 2025

Practical Evaluation of AutoML Platforms for Clinical Data Science

Shubhranshu Dutta

Source category: Poster Presentations

Author collections: Shubhranshu Dutta

PHUSE · 2025Paper PP11PHUSE EU Connect 2025

Pragmatism Meets Precision

Andrea Parodi

Source category: Poster Presentations (PP)

Author collections: Andrea Parodi

PHUSE · 2025Paper AR06PHUSE US Connect 2025

Predictive Analytics for Adverse Event Underreporting

Steven Gilbert

Source category: Analytics Risk-based Monitoring

Author collections: Steven Gilbert

PHUSE · 2025Paper OS03PHUSE US Connect 2025

Python’s Future in Clinical Trials: Innovations and Collaborative Advancements

Shweta Shukla; Sohan Lal

Source category: OS

Author collections: Shweta Shukla · Sohan Lal

PHUSE · 2025Paper DS03PHUSE EU Connect 2025

Qualitative ADaM Datasets and Define-XML Without Using ADaM Specs

Pieter Coppens

Source category: Data Standards & Governance (DS)

Author collections: Pieter Coppens

PHUSE · 2025Paper LI06PHUSE EU Connect 2025

Quality as an Innovation Catalyst: Transforming Tech-QA Dynamics

Megan Lafferty; Christopher White

Source category: Leadership Through Innovation (LI)

Author collections: Christopher White

PHUSE · 2025Paper LI09PHUSE EU Connect 2025

R Adoption and Change Management A Large CRO Perspective

Martin Brown; Lynn Clipstone

Source category: Leadership Through Innovation (LI)

Author collections: Lynn Clipstone

PHUSE · 2025Paper PP17PHUSE US Connect 2025

R Consortium’s R-Based Test Submission Package for FDA Evaluation: A Milestone and a New Frontier in R-Based Regulatory Submissions

Joel Laxamana

Source category: Poster Presentations

PHUSE · 2025Paper OS05PHUSE US Connect 2025

R Package Risk Assessment: Balancing Programmatic and Human Input

Chelsea Dickens

Source category: OS

Author collections: Chelsea Dickens

PHUSE · 2025Paper LI08PHUSE EU Connect 2025

R-Burst: The User Support Approach Shaping GSKs Open-Source Strategy

Andy Nicholls; Shannon Haughton

Source category: Leadership Through Innovation (LI)

Author collections: Andy Nicholls · Shannon Haughton

PHUSE · 2025Paper RE05PHUSE US Connect 2025

Real-World Data – Analysis-Ready Datasets: A Standardised, Specialised and Innovative Data Solution for Efficient Real-World Data Analysis

Nayan Chaudhary; Navdeep Pal

Source category: Real-world Evidence

PHUSE · 2025Paper AR07PHUSE US Connect 2025

Real-World Examples of eCOA Compliance and Audit Trail Review Using Advanced Statistical Methodology

Jamie O'Neill

Source category: Analytics Risk-based Monitoring

Author collections: Jamie O'Neill

PHUSE · 2025Paper CT11PHUSE EU Connect 2025

RECISTance Is Useless, A Novel Visualisation Of RECIST Data Using Bubbles, On A Time-line

Daniel Lindenbaum

Source category: Coding Tips & Tricks (CT)

Author collections: Daniel Lindenbaum

PHUSE · 2025Paper ET04PHUSE US Connect 2025

Redefining FDA Submissions: The Future of Interactive R Shiny Dashboards

André Veríssimo; Vedha Viyash

Source category: Emerging Trends

Author collections: André Veríssimo · Vedha Viyash

PHUSE · 2025Paper PP05PHUSE EU Connect 2025

Redefining the Role of the Statistical Programmer in an AI-Driven World

Chris Wood; James Shipley–burgess

Source category: Poster Presentations (PP)

Author collections: Chris Wood

PHUSE · 2025Paper SA07PHUSE US Connect 2025

Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission

Shashikant Kumar; Mrityunjay Kumar

Source category: Submissions & Agencies

Author collections: Shashikant Kumar · Mrityunjay Kumar

PHUSE · 2025Paper SA10PHUSE US Connect 2025

Regulatory Submissions – Exciting, Challenging, or Both?

Ganesh Gupta; Randi McFarland

Source category: Submissions & Agencies

Author collections: Randi McFarland

PHUSE · 2025Paper SD04PHUSE EU Connect 2025

Reinventing the Deliverable Tracker from Excel to Dashboard

Megan Harries

Source category: Software Demonstrations (SD)

Author collections: Megan Harries

PHUSE · 2025Paper PP33PHUSE EU Connect 2025

Reproducibility, Lineage and Control: Building a Traceability Framework for the Modern Clinical Trial

Bill Qubeck; Shilpa Sood

Source category: Poster Presentations (PP)

Author collections: Bill Qubeck · Shilpa Sood

PHUSE · 2025Paper DV01PHUSE EU Connect 2025

ResponDex Response Data Exploration Dashboard

Sevak Kamalyan; Alexander Mkrtchyan

Source category: Data Visualisation (DV)

Author collections: Sevak Kamalyan · Alexander Mkrtchyan

PHUSE · 2025Paper ML13PHUSE EU Connect 2025

Rethinking Automation in the AI Era

James Zee; Liz Cole

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

Author collections: Liz Cole

PHUSE · 2025Paper AS10PHUSE US Connect 2025

Revolutionising Cancer Trials with Adaptive Designs and Bayesian Analysis

Navneet Jha

Source category: Analytics & Statistics

PHUSE · 2025Paper SD01PHUSE EU Connect 2025

Revolutionising Clinical Trial Monitoring and Data Analysis with AR- and VR-Driven Immersive Analytics

Tej Narayan Yadav; Saurabh Das

Source category: Software Demonstrations (SD)

Author collections: Saurabh Das

PHUSE · 2025Paper ML08PHUSE US Connect 2025

Revolutionising Clinical Trials with Intelligent Protocol Automation

Pankaj Attri; Sundaresh Sankaran

Source category: Machine Learning, AI and Large Language Models

Author collections: Pankaj Attri · Sundaresh Sankaran

PHUSE · 2025Paper ML03PHUSE US Connect 2025

Revolutionising Clinical Trials: Gen AI-Powered Biometrics Breakthroughs

Kevin Lee

Source category: Machine Learning, AI and Large Language Models

Author collections: Kevin Lee

PHUSE · 2025Paper ML19PHUSE US Connect 2025

Revolutionising Drug Development with Optimised Large Language Models (LLMs)

Chris McSpiritt

Source category: Machine Learning, AI and Large Language Models

Author collections: Chris McSpiritt

PHUSE · 2025Paper AR03PHUSE US Connect 2025

Risk Based Quality Management (RBQM) in Clinical Data Management

Marcin Kot; Anna Górecka

Source category: Analytics Risk-based Monitoring

PHUSE · 2025Paper AR01PHUSE US Connect 2025

Risk-Informed Data Strategies to Streamline Trial Complexity

Tiina Erb

Source category: Analytics Risk-based Monitoring

PHUSE · 2025Paper OS17PHUSE US Connect 2025

Risk.assessr: A Tool for Assessing and Mitigating Risks with Open-Source R Packages in Clinical Trials

Andre Couturier; Edward Gillian

Source category: OS

Author collections: Andre Couturier · Edward Gillian

PHUSE · 2025Paper CT10PHUSE EU Connect 2025

Risk.assessr: Extracting OOP Function Details

Edward Gillian; Hugo Bottois

Source category: Coding Tips & Tricks (CT)

Author collections: Edward Gillian · Hugo Bottois

PHUSE · 2025Paper PP15PHUSE EU Connect 2025

Roadmap to an ODAC: The Journey to and Through an FDA Oncologic Drug Advisory Committee as a Study Lead Programmer

Charles Wright

Source category: Poster Presentations (PP)

PHUSE · 2025Paper PP27PHUSE EU Connect 2025

Robust Programming Strategies for Exposure to ADaM Datasets

Susann Grill

Source category: Poster Presentations (PP)