Xbiom™ Insights – Clinical Biomarker is a semantically integrated repository for data from clinical trials, molecular biomarkers, bio-sample availability and bioinformatics registries. The platform provides secure access to users and other applications to search for highly stratified cohorts, retrospectively or prospectively, using simple query masks and easy Boolean logic across all datasets collected during the drug development lifecycle.
Xbiom™ Insights – Nonclinical allows discovery of toxicology signals and patterns across studies and species within nonclinical studies. This module permits easy cross-study search through the use of a nonclinical data repository which contains normalized data through semantic integration.
Xbiom™ Regulatory – Clinical allows sponsors to streamline study workflows with their CROs by defining the data models, folders and terminology prior to study start. Sponsors can receive data for interim analysis until the study is completed. This module enables the planning and packaging of studies for submission in eCTDs, while in tandem allowing for statistical analysis of the data available in the clinical trial repository and the Xbiom™ Insights – Clinical Biomarker module.
Xbiom™ Regulatory – Nonclinical gives users an end-to-end suite for the specification, collection, analysis and final packaging of nonclinical study data to the SEND format. This new standardized data format, CDISC SEND, is now mandated by the FDA. The solution allows sponsors to set a study protocol for their labs and CROs to specify which domains, controlled terminologies and data formats each will collect for a study even before the study initiation. Outputs from these sources are directly uploaded to the module for analysis and after successful QA, are easily packaged into a submission-ready SEND package.