3 papers
cs.CL2025
Automated Generation of Custom MedDRA Queries Using SafeTerm Medical Map
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
In pre-market drug safety review, grouping related adverse event terms into standardised MedDRA queries or the FDA Office of New Drugs Custom Medical Queries (OCMQs) is critical fo…
cs.CL2025
Performance of the SafeTerm AI-Based MedDRA Query System Against Standardised MedDRA Queries
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
In pre-market drug safety review, grouping related adverse event terms into SMQs or OCMQs is critical for signal detection. We assess the performance of SafeTerm Automated Medical…
cs.CL2025
Knowledge-based Graphical Method for Safety Signal Detection in Clinical Trials
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
We present a graphical, knowledge-based method for reviewing treatment-emergent adverse events (AEs) in clinical trials. The approach enhances MedDRA by adding a hidden medical kno…