XBIOM VDR

XBIOM VDR (Virtual Data Room) by PointCross Life Sciences is a secure, cloud-based data exchange and curation platform designed for sponsors, CROs, FSPs, and laboratories involved in clinical and nonclinical research. It enables easy, encrypted transfer of study data among all contributing and consuming parties by establishing Virtual Data Rooms within a DMZ (Demilitarized Zone) — a dedicated subnetwork that securely exposes external-facing data exchange services.

The platform is purpose-built for biopharma R&D organizations managing complex, multi-party clinical data flows, including those working with EDC systems, bioanalytical CROs, biomarker assay providers, and statistical computing environments. XBIOM VDR supports the full lifecycle of clinical data maturation, from initial data inflow through curation, standardization, and regulatory submission readiness.

Data Ingestion and Exchange Capabilities

• Virtual Data Rooms are set up in a DMZ to provide secure, encrypted data exchange between sponsors, CROs, FSPs, and labs.
• Automatically scheduled crawlers pick up data submitted to VDRs or pull data from disparate sources via authorized API access.
• Supports multiple simultaneous inflows to accommodate complex sponsor data flow arrangements involving multiple FSPs and CROs.
• Ingests a wide variety of source data types, including EDC patient data from clinical sites, bioanalytical data from CROs, and biomarker assay data such as immuno-assays, cell phenotyping, gene, protein, and transcriptomics assays.
• Handles partial or completed standardized SDTM data domains from various CROs and FSPs.
• Facilitates exchange of SDTM and ADaM datasets between contracting facilities during TFL and CSR preparation.
• Supports data exchange between the Clinical Data Repository (CDR) and Statistical Computing Environments (SCE) running SAS, R, and Python, as well as metadata exchange between the MDR and CDR.

Data Curation and Quality Tools

• Ingested data is automatically moved into a structured curation process upon receipt.
• Dashboards and visualization tools help identify data gaps, misidentified data, and issues with visits or cycles.
• An integrated eDataValidator checks ingested data for format and structure compliance against expected standard models.
• Errors identified during curation can be annotated directly within the platform, supporting thorough data quality management.

Data Traceability and Compliance

• Automated tracking of all data changes is maintained and logged to support audits and regulatory reporting.
• Annotation of errors and curation activities satisfies 21 CFR Part 11 record-keeping requirements.
• An errata report is generated as a result of the curation process, providing a full traceability record linking SDTM-generated data back to its original source data.
• The errata report serves as a powerful tool for biometrics and data management teams working with clinical operations to correct GCP data systems, including the EDC.

XBIOM VDR is part of the broader XBIOM Solutions Platform from PointCross Life Sciences, which also encompasses metadata repository management, regulatory submission tools, and clinical and nonclinical insights capabilities. The platform is designed to integrate seamlessly into existing sponsor infrastructure, including SCE environments and CDR systems, making it suitable for organizations with established statistical computing workflows.