DateNovember 16-19, 2025 LocationHamburg, Germany

We hope to see you at the upcoming PHUSE EU Connect. Schedule a meeting with our team using the form to the right.

Check Yourself: Edit Checks and Queries Made Easy with Shiny

Author: Kirsty Lauderdale

Effective data management is critical in clinical trials to ensure clean, accurate, and compliant datasets. Shiny allows us to build applications tailored for clinical data management and enables CDMs to move beyond static listings and spreadsheets. By integrating edit check logic, discrepancies and flags can be raised in real time with minimal manual effort. Automated queries generated based on predefined rules/dynamic thresholds support consistent and efficient data cleaning. Customizable filters, drill-down views, and responsive visualizations make it easier for CDMs/DMs to explore key issues across subject-level and study-wide datasets. Strategies such as modular design, reactive programming, and server-side processing ensure smooth performance with large clinical datasets. Features such as audit logging and built-in metrics enhance traceability and oversight. See Shiny go beyond visualizations—serving as a practical, efficient platform for improving the speed, accuracy, and transparency of clinical data review.

May the Code be with You: Entering the pharmaverse Galaxy

Author: Kirsty Lauderdale

The pharmaverse offers a practical, open-source alternative for clinical trial programming. This collection of R packages supports the full spectrum of clinical trial workflows—from building CDISC datasets and analysis outputs to preparing regulatory deliverables. This presentation walks through the clinical trial lifecycle, highlighting key pharmaverse tools, their usage, and how to get started. Attendees will see how pharmaverse makes clinical programming more consistent, transparent, and efficient.

Developing a Compliant and Scalable Statistical Computing Environment Based on PHUSE SCE Guidelines

Author: Mark Sellors

This session introduces Ageirein, Atorus’ modular deployment framework based on the PHUSE SCE White Paper. Ageirein is designed for GxP-compliant, scalable statistical computing, embedding validation, traceability, and audit readiness from the start. It supports both exploratory and production workflows, enabling organizations to modernize their data science environments while meeting compliance requirements.

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