CONTEXT
A client conducting a multi-centre vaccine trial required real-time monitoring of adverse events (AEs) across participating sites. Relying on static listings and manual reports caused delays in detecting and responding to potential safety signals, creating risk in trial oversight.

RESOLUTION
Our team designed and implemented a custom Shiny dashboard that pulled daily data from the electronic data capture (EDC) system. It featured interactive filters by site, age group, and treatment arm, enabling granular safety review. Statistical process control (SPC) logic flagged unusual AE spikes, while automated R Markdown reports provided dynamic visualizations and timely updates for trial stakeholders.

RESULT
The solution enabled near real-time monitoring of safety data, allowing the client to quickly detect and escalate serious adverse events (SAEs). It significantly improved visibility across sites, enhanced stakeholder communication, and strengthened pharmacovigilance workflows during the trial.