Exchange study data securely. Curate with confidence.
XBIOM™ Virtual Data Rooms, set up in a DMZ, give CROs, Labs, and Sponsors an easy, secure way to exchange data. Automated crawlers ingest, validate, and move data into curation with full traceability.
From exchange to curated, traceable data
The VDR moves data through an automated pipeline, from secure intake to a fully traceable curation record.
Secure Exchange
CROs, Labs, and Sponsors submit data to Virtual Data Rooms set up in a DMZ, encrypted and held per contributor.
Automated Ingestion
Scheduled crawlers pick up submitted data or pull from disparate sources through authorized API access.
Curation & Validation
Dashboards and visualization tools identify gaps and anomalies while eDataValidator checks format and structure.
Traceability & Errata
Every change is tracked and logged for audits, with an errata report linking SDTM back to source data.
One inbox for every data source
XBIOM has automatically scheduled crawlers that pick up data submitted to the VDRs, or pull data down from disparate sources through authorized API access. Depending on how a sponsor manages their clinical data flow and maturation, there may be multiple inflows as FSPs and CROs perform their functions.
- ✓ EDC patient data from the clinic and bioanalytics data from CROs
- ✓ Biomarker assays including immunoassays, cell phenotyping, gene, protein and transcriptomics
- ✓ SDTM & ADaM sets exchanged with contracting facilities for TFL and CSR generation
- ✓ Data exchange between the CDR and SCE, and metadata between the MDR and CDR
Dashboards & visualization
Data moves automatically into a curation process where dashboards and visualization tools help identify data gaps, misidentified data, visits or cycles.
Built-in eDataValidator
An eDataValidator checks the ingested data for format and structure against expected standard models.
21 CFR Part 11 record keeping
Errors found during curation may be annotated, and these annotations serve the needs of 21 CFR Part 11 record keeping.
Every change tracked, logged, and traceable
Data traceability is maintained with automated tracking of changes, logged for audits or reporting. An errata report generated as a result of curation is maintained and provides the traceability record for the data used to generate SDTM back to the source data.
The errata report is also a powerful tool for the biometrics and data management teams working with clinical operations to correct the GCP data systems, including the EDC.
Key terms & acronyms
The vocabulary used across XBIOM data exchange and curation workflows.
Clinical Data Repository and Processing Layer
Contract Research Organization
Clinical Study Report
Demilitarized zone; a physical or logical subnetwork that contains and exposes an organization’s external-facing service such as a VDR
Electronic Data Capture for patient data at the clinic
Functional Service Provider, a specialized service provider
Statistical programming and analysis software and server
Statistical Computing Environment for SAS, R and Python programmers to work with data to generate SDTM, ADaM, TFLs
Tabulations, Figures and Listings of analysis-ready data
Virtual Data Room located in a DMZ for exchanging data securely and encrypted, holding data for each contributor or consumer in the exchange
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