Secure Exchange

XBIOM™ Virtual Data Room
Data Exchange & Curation

A unified Virtual Data Room for ingesting, curating, and exchanging study data between Sponsors, CROs, and Labs. Secure, automated, and fully traceable.

Secure DMZ for Global Collaboration

Xbiom provides for easy, secure exchange of data among CROs, Labs, and Sponsors with its Virtual Data Rooms set up in a DMZ (Demilitarized Zone). Unlike traditional FTP or email, Xbiom ensures data integrity and security while automating the intake process.

  • 🛡️ Automated crawlers pickup submitted data instantly
  • 🛡️ Pull down data via authorized APIs from EDC and Labs
  • 🛡️ Support for Clinical, Bio-analytics, and Biomarker assays
  • 🛡️ Ingest partial or complete SDTM/ADaM datasets

Data Sources Supported

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EDC Systems
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Biomarker Assays
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CRO Portals
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FSP Data
SDTM/ADaM
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Ongoing Monitoring

Automated Curation & Traceability

Data is automatically moved into a curation process where dashboards help identify gaps and errors before they become compliance risks.

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Continuous Ingestion

Depending on how a sponsor manages clinical data flow, multiple inflows from FSPs and CROs are supported, including exchanges between CDR and SCE.

21 CFR Part 11 Traceability

Automated tracking of changes with full audit logs. Errors found during curation are annotated, serving the needs of record keeping and biometrics teams.

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Errata Reporting

Generate errata reports that provide the traceability record for data used to generate SDTM back to the source data, aiding Clinical Operations.