One Platform. One Source of Truth. Automate the lifecycle from ingestion to regulatory submission with a secure, future-proofed system designed for regulated life sciences.
Manual data wrangling and disconnected systems jeopardize regulatory timelines and data integrity. In a regulated environment, you cannot afford uncertainty.
Inconsistent validation and manual errors increase the probability of regulatory queries and delays.
Disconnected clinical and nonclinical data prevents holistic analysis and slows down decision-making.
Transferring sensitive proprietary data to external tools exposes IP to unnecessary security risks.
Deployed securely within your corporate firewall, Xbiom Whisperer enables plain-English queries of your proprietary study data without ever exposing IP to external clouds.
A complete ecosystem designed for scale, compliance, and rigorous data governance.
Central MDR with smart transformers enforcing standards automatically.
Automated SDTM, ADaM, and TFLs generation with validation workflows.
Exchange-standard agnostic repositories optimized for reuse and traceability.
Single solution (eDV) for SDTM, ADaM, and SEND supporting IND, NDA, and BLA.
Integrated analytics and visualization across stratified cohorts.
R & Python support with optional SAS integration for advanced analysis.
Dynamic tables, listings, and figures for research review and publication.
SaaS hosted on AWS/Azure or deployed fully on-premises.
Reduce data programming time from weeks to days with automated ingestion and transformation pipelines.
Submit with confidence knowing every dataset is validated against 21 CFR Part 11 and FDA standards.
Maintain a single, immutable source of truth for all clinical and nonclinical assets.
Join the leading organizations using Xbiom to ensure data integrity, compliance, and speed to market.
