High attrition rates (almost 90%) in Phase-1 trials due to safety issues raise questions about earlier nonclinical predictivity. The partition between nonclinical and clinical systems is a major barrier.
Xbiom is designed to hold all study data—whether animal studies, clinical trials, or biomarker assays—in a common UDM repository, enabling cross-species and intra-species analysis.
Neural networks analyze associations across compounds and pre-clinical studies to AE events in early human studies.
Computes dose-related and temporal trends to classify signals as weak pharmacological or strong toxic levels.
Toxic signals are reconciled against study report findings while weaker signals are accumulated for pattern analysis.
Analysis and visualization of study and cross-study analytics.
Maintain data with harmonized terminology and normalized units for easy repurposing.
Monitoring of interim data from ongoing studies.
Loading adaptors for disparate sources as well as SEND datasets.
Automated generation of SEND datasets from the repository.
Generate Figures, Tables, and Listings with annotations for any cohort.
