The Xbiom MDR (Metadata Repository) from PointCross Life Sciences is a solution to simplify the management of global standards, therapeutic area-specific needs, and indication-specific rules for data Collection, Exchange, Analysis, and Reporting.
Xbiom™ MDR is configured with:
Foundational Metadata and Ontology platform functions, including:
- Role-Based User Management, authentication, authorization, security, permissioning, user access and workflow delegations of authority
- Ontology, taxonomy, and standards management for CDISC SDTM, ADaM, CDASH, Protocol, Define.XML, SAP, SEND etc. (de-jure standards) and de-facto standards from Sponsor or CRO, Specialty Labs, other standards and Controlled Terminologies.
- Interfaces and APIs for internal enterprise and external systems integration and inter-operation, including EDC systems, Data Collection Systems / Instruments, and Clinical Data Repositories for seamless and traceable metadata management and organizational workflows
- Configurable dashboards for object, variable, value-level metadata
- Built-in validation rules to ensure data compliance with CDISC standards and specific study requirements in real time
Why Customers Choose Xbiom™ MDR:
1. Comprehensive Standards Integration
- CDASH: Ensures uniformity and accuracy in data collection across clinical trials, integrating CDASH standards directly into your processes for seamless downstream analysis.
- SDTM: Simplifies compliance with SDTM standards, enabling efficient preparation and submission of data that meets global regulatory requirements (e.g., FDA, PMDA).
- ADaM: Supports the creation of standardized analysis datasets, ensuring accurate metadata for reports and enhancing statistical analysis efficiency.
- Controlled Terminology (CT): Manages CDISC-controlled terminologies to maintain consistency in language and data values across trials and regions.
- Reference Data Management: Facilitates the management of reference data (e.g., MedDRA, WHODrug) to ensure alignment of biomarker mapping with the global terminology and the latest regulatory conformance standards.
2. Therapeutic Area and Indications
- Therapeutic Area-Specific Standards: Supports tailored data standards for various therapeutic areas (e.g., oncology, cardiology) to ensure compliance with industry guidelines.
- Indication-Specific Customization: Allows for the definition of unique data collection standards, providing full flexibility to meet the specific needs of each study.
3. Automated Workflows for Enhanced Efficiency
- Automated Data Transformation: Streamlines the conversion of raw data into SDTM or ADaM formats, expediting the data submission process.
- Standardized Validation: Provides built-in validation rules to ensure data compliance with CDISC standards and specific study requirements in real time.
4. Robust Metadata Validation
- Real-Time Compliance Checks: Ensures that data adheres to industry standards as it is processed, minimizing errors and improving data quality. Data quality dashboards support data management, standards management, and biometrics programming teams with harmonized access
- Custom Validation Options: Allows for the creation of tailored validation rules to meet unique study or sponsor requirements
- Thousands of studies validated and successfully submitted using Xbiom™ validation workflows
Business Benefits of Xbiom MDR
- Accelerated Time-to-Market: Centralizing and standardizing clinical trial data streamlines processes, reducing manual effort and expediting regulatory submissions.
- Enhanced Data Quality and Compliance: Built-in support for CDISC standards and automated validation reduces the risk of costly rework and submission delays.
- Seamless EDC Integration: Direct integration with leading Electronic Data Capture (EDC) vendors ensures smooth metadata exchange, enhancing operational efficiency.
- Improved Collaboration: Centralized metadata repository fosters collaboration across global teams, while customizable workflows and automation tools enhance productivity.
- Future-Proof Data Management: The Unified Data Model (UDM) normalizes data for easy adaptation to evolving standards, safeguarding your investment.
- Cost Reduction Through Automation: Automation of metadata management and regulatory reporting lowers operational costs while maintaining high data accuracy.
- Streamlined Regulatory Submissions: Simplifies the preparation of submission packages, facilitating faster approval processes.
- Scalability for Global Operations: Supports the complexities of global trials, accommodating multiple therapeutic areas, indications, and regional regulations.
Ensure your data traceability, simplify your data management workflows, and manage your data transformations and metadata as they evolve over time with a one-truth, one-source approach.
To explore Xbiom™ MDR or schedule a demo, contact us at hello@pointcross.com and a member of our team will be in touch with you.