OpenRBQM Extended: Endpoint Monitoring, Root Cause Analysis and Workflows
Source category: Analytics Risk-based Monitoring
Author collections: Spencer Childress · Jeremy Wildfire
THE COMMUNITY ARCHIVE
PHUSE Papers ArchivePage 19
Browse indexed publications from PHUSE. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.
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3,716 papers · Showing 721–760
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
Pivoting to AI: Turning Career Transition into Innovation
Source category: Poster Presentations
Planning Ahead: A Novel Approach to Creating Synthetic Immunogenicity Data
Source category: Analytics & Statistics
Author collections: Surendra Yajamanam
Plunging into Pools: Dive into a Comparative Analysis of Pooled TLFs with R
Source category: Poster Presentations (PP)
Pooling Studies Through Code Traceability
Source category: Trends & Technology (TT)
Poseidon: Streamlined Regulatory Screening of HA Websites with AI/ML to Extract Updates and Reduce Manual Efforts
Source category: Machine Learning, AI & Large Language Models (ML)
Posit Team: Metadata-Driven Risk Assessment and Surfacing Validated R Packages
Source category: OS
Author collections: Philip Bowsher · Michael Mayer
Positron: Overview for Pharma
Source category: Emerging Trends
Author collections: Philip Bowsher · Cole Arendt
Powering Up Programming Milestones: From Chaos to Cohesion
Source category: Trends & Technology (TT)
Practical Evaluation of AutoML Platforms for Clinical Data Science
Source category: Poster Presentations
Author collections: Shubhranshu Dutta
Pragmatism Meets Precision
Source category: Poster Presentations (PP)
Author collections: Andrea Parodi
Predictive Analytics for Adverse Event Underreporting
Source category: Analytics Risk-based Monitoring
Author collections: Steven Gilbert
Python’s Future in Clinical Trials: Innovations and Collaborative Advancements
Source category: OS
Author collections: Shweta Shukla · Sohan Lal
Qualitative ADaM Datasets and Define-XML Without Using ADaM Specs
Source category: Data Standards & Governance (DS)
Author collections: Pieter Coppens
Quality as an Innovation Catalyst: Transforming Tech-QA Dynamics
Source category: Leadership Through Innovation (LI)
Author collections: Christopher White
R Adoption and Change Management A Large CRO Perspective
Source category: Leadership Through Innovation (LI)
Author collections: Lynn Clipstone
R Consortium’s R-Based Test Submission Package for FDA Evaluation: A Milestone and a New Frontier in R-Based Regulatory Submissions
Source category: Poster Presentations
R Package Risk Assessment: Balancing Programmatic and Human Input
Source category: OS
Author collections: Chelsea Dickens
R-Burst: The User Support Approach Shaping GSKs Open-Source Strategy
Source category: Leadership Through Innovation (LI)
Author collections: Andy Nicholls · Shannon Haughton
Real-World Data – Analysis-Ready Datasets: A Standardised, Specialised and Innovative Data Solution for Efficient Real-World Data Analysis
Source category: Real-world Evidence
Real-World Examples of eCOA Compliance and Audit Trail Review Using Advanced Statistical Methodology
Source category: Analytics Risk-based Monitoring
Author collections: Jamie O'Neill
RECISTance Is Useless, A Novel Visualisation Of RECIST Data Using Bubbles, On A Time-line
Source category: Coding Tips & Tricks (CT)
Author collections: Daniel Lindenbaum
Redefining FDA Submissions: The Future of Interactive R Shiny Dashboards
Source category: Emerging Trends
Author collections: André Veríssimo · Vedha Viyash
Redefining the Role of the Statistical Programmer in an AI-Driven World
Source category: Poster Presentations (PP)
Author collections: Chris Wood
Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission
Source category: Submissions & Agencies
Author collections: Shashikant Kumar · Mrityunjay Kumar
Regulatory Submissions – Exciting, Challenging, or Both?
Source category: Submissions & Agencies
Author collections: Randi McFarland
Reinventing the Deliverable Tracker from Excel to Dashboard
Source category: Software Demonstrations (SD)
Author collections: Megan Harries