Xbiom provides for easy, secure exchange of data among CROs, Labs, and Sponsors with its Virtual Data Rooms set up in a DMZ. Xbiom has automatically scheduled crawlers that:
- Pickup data that has been submitted to these VDRs, or
- Pull down data from disparate sources through authorized API access. The source data includes, but are not limited to, EDC patient data from the clinic, Bio analytics data from CROs; Biomarker Assays such as Immuno-Assays, Cell Phenotyping, gene, protein and transcriptomics assays; and various partial or completed standardized SDTM data domains from various CROs and FSPs.
Depending on how a sponsor elects to manage their clinical data flow and maturation, there may be multiple inflows as FSPs and CROs perform their functions. During the preparation of TFLs for CSR generation, sponsors may also exchange SDTM and ADaM sets from their contracting facilities. The sponsors may use existing SCE running SAS servers that need further exchange of data between the CDR and SCE, and metadata between the MDR and CDR.
The data is automatically moved into a curation process where dashboards and visualization tools help identify data gaps, misidentified data, visits or cycles, with an eDataValidator that checks the ingested data for format and structure against expected standard models.
Data Traceability is maintained with automated tracking of changes and logged for audits or reporting. Errors found during curation may be annotated and these serve the needs of 21 CFR Part 11 record keeping. 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 for correcting the GCP data systems including the EDC.
Definitions:
- CDR – Clinical Data Repository and Processing Layer
- CRO – Contract Research Organization
- CSR – Clinical Study Report
- DMZ – Demilitarized zone, a physical or logical subnetwork that contains and exposes an organization’s external-facing service such as VDR
- EDC – Electronic Data Capture for patient data at the clinic
- FSP – Functional Service Provider, a specialized service provider
- SAS – Statistical programming and analysis software and server
- SCE – Statistical Computing Environment for statistical SAS, R and Python programmers to work with data to generate SDTM, ADaM, TFLs
- TFL – Tabulations, Figures and Listings of analysis ready data
- VDR – Virtual Data Room located in a DMZ for exchanging data securely, encrypted and hold the data for each contributor or consumer in the exchange