Xbiom

Xbiom is a comprehensive study data automation platform designed to streamline the management of clinical and nonclinical study data. It incorporates Xbiom Whisperer, an AI capability that leverages Retrieval Augmented Generation (RAG) to facilitate intuitive access to data through a Large Language Model chat interface. This ensures that proprietary trial information remains secure within corporate firewalls, avoiding exposure to external systems.

The platform automates the lifecycle of study data, including ingestion, exchange among labs and CROs, curation, and preparation for future-proofed repository storage. It supports the generation of errata registers for EDCs and LIMS, and the creation of submission-ready SDTM, ADaM, and TFLs using R and Python, with optional SAS server integration.

Key Features:

• Meta Data Repository and Automated Smart Transformer for standardization and harmonization.
• Universal Data Model for exchange standard agnostic data storage.
• XBIOM IGO for immersive visualization of research data.
• Analytics and visualization tools for nonclinical studies, including SEND and eDV data validation.
• Support for IND, NDA, and BLA preparation with limitless validation capabilities.

Xbiom is available as a Software as a Service (SaaS) hosted on AWS or Azure, with on-premises installation options. This flexibility ensures that organizations can choose the deployment model that best suits their needs.