In a world where clinical trials are becoming more complex, managing clinical data effectively is crucial. PointCross Life Sciences offers a comprehensive solution with our Xbiom Platform. The Xbiom Platform is designed with a modular, “Lego block” approach, making it seamlessly integrable with both your upstream and downstream systems. It comes fully equipped with powerful modules like Smart Transformation, MDR (Metadata Repository), and eDV (eDataValidator). Additionally, the platform includes the out-of-the-box UDM (Unified Data Model), engineered to transform the way you manage, structure, and leverage your clinical data for optimized efficiency and compliance.
Xbiom Smart Transformation: Revolutionizing Data Workflows
Xbiom Smart Transformation ensures that clinical data from multiple sources, such as EDC, eCOA, and laboratory data, is harmonized, standardized, and ready for immediate analysis or regulatory submission. Here’s how we enable seamless clinical data transformation:
- Automated Data Ingestion: Xbiom automates the ingestion of structured and unstructured data from various sources, including real-time data from wearables and legacy systems. This eliminates manual data entry and reduces the risk of errors, enhancing the quality and timeliness of your datasets.
- Data Standardization: With built-in support for global data standards such as CDISC (SDTM, ADaM, SEND), Xbiom ensures that your data is automatically standardized, enabling faster and more efficient regulatory submissions. The data is normalized through the Unified Data Model (UDM), which ensures consistency across studies and future-proofing for updates to new versions of SDTM IG (Implementation Guides).
- Real-Time Validation: Xbiom’s eDV (eData Validator) validation engine checks for errors, missing data, and inconsistencies in real time. This allows for timely corrections, reducing data processing delays and ensuring data integrity throughout your clinical trials.
- Interoperable Data for Analytics: Through metadata-driven workflows, your data is not only structured but also enriched with metadata that supports indexing, searchability, and traceability, simplifying downstream analysis and decision-making.
MDR: Metadata Repository for Enhanced Data Governance
The Metadata Repository (MDR) is the cornerstone of effective data management in Xbiom. It provides an indexed, searchable, and highly organized repository of your clinical data, enabling traceability, audit readiness, and governance across all stages of a clinical trial.
Key features include:
- Centralized Data Hub: The MDR acts as a unified repository for all trial data. It creates a comprehensive and accessible record of all metadata, making it easy to retrieve, compare, and trace data from any trial, across sites and phases. It streamlines your data governance by ensuring that all metadata is centrally stored and managed.
- Data Lineage and Traceability: The MDR maintains a complete lineage of data—from ingestion to transformation—ensuring complete traceability. Each modification, update, and process within your data pipeline is tracked and recorded, providing an audit-ready trail that satisfies regulatory scrutiny.
- Searchable Metadata Index: With a fully indexed and searchable structure, MDR allows users to query and retrieve data based on specific metadata attributes. This facilitates fast data retrieval, efficient data pooling, and rapid responses to regulatory or internal queries.
- Version Control for Data Standards: MDR ensures that your clinical data is always aligned with the latest data standards. It supports multiple versions of SDTM, allowing your organization to easily up-version to new regulatory standards without disrupting your existing data workflows.
UDM: Unified Data Model for Future-Proof Data Management
The Unified Data Model (UDM) is at the heart of Xbiom’s capability to standardize and normalize clinical data across multiple trials. Designed to handle evolving regulatory standards, UDM ensures that your data is always ready for future needs and can easily adapt to changes in CDISC standards, including new SDTM IG versions.
- Data Normalization: UDM enables the standardization of data across studies by applying a consistent model that organizes data from diverse sources into a unified format. This standardization ensures that all data conforms to the required specifications, enabling seamless integration, analysis, and reporting.
- Future-Proof Flexibility: UDM is built with the future in mind. It is fully scalable and adaptable to new industry standards, making it easy to up-version your data as new SDTM Implementation Guides (IGs) are released. You no longer need to rework old datasets or worry about incompatibility with emerging regulations.
- Indexed and Searchable Repository: UDM’s data repository is indexed for searchability, enabling quick access to trial-specific data, metadata, and insights. Researchers, clinical teams, and regulatory bodies can effortlessly search, retrieve, and use data, speeding up processes like regulatory submissions.
- Efficient Generation of ISS & ISE: UDM simplifies the generation of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. By normalizing and indexing the data across multiple trials, UDM enables you to compile these critical summaries with ease and accuracy, meeting regulatory submission requirements in a fraction of the time.
Why PointCross Life Sciences?
At PointCross Life Sciences, we understand the challenges involved in managing large, diverse, and evolving clinical data. Our innovative solutions—Xbiom Smart Transformation, MDR, eDV and UDM—not only streamline the data management process but also ensure that your data is future-proof, secure, and fully compliant with global regulatory standards.
- Comprehensive and Scalable: Whether you’re handling small-scale trials or global multi-site studies, Xbiom’s solutions scale to meet your needs. Our platform supports both local and global studies, ensuring consistent data quality and governance.
- Regulatory Confidence: With built-in support for CDISC standards and seamless up-versioning capabilities, our platform ensures your data is always ready for submission, keeping you ahead of regulatory changes.
- Automation and Innovation: We automate the most complex data workflows, reducing manual errors and ensuring faster timelines. Our advanced automation features free up your team to focus on higher-value activities like data analysis and decision-making.
- Expert Support: Our team of clinical data experts provides hands-on support throughout the data transformation journey. From initial setup to ongoing assistance, we ensure your organization gets the most out of our solutions.
Ready to Transform Your Clinical Data Management?
PointCross Life Sciences is here to help you streamline, standardize, and future-proof your clinical data operations. Our Xbiom Smart Transformation, MDR, and UDM modules are designed to ensure that your data is always accurate, compliant, and ready for regulatory submission.
Contact us today to schedule a personalized demo or learn more about how our solutions can revolutionize your clinical data management.