Services
Metadata Services
At VAICS, our Metadata services is designed to streamline and enhance the efficiency of clinical data standards implementation. Metadata management is crucial for ensuring compliance with CDISC standards, including SDTM, ADaM, and Define-XML, and plays a pivotal role in the successful submission of clinical trial data to regulatory authorities. Our comprehensive approach ensures that your metadata is meticulously organized, managed, and maintained, providing a solid foundation for consistent data interpretation and efficient regulatory submissions.
Our key services
Comprehensive meta data services designed to streamline and enhance the efficiency of clinical data standards implementation.
Centralized metadata repository
Comprehensive metadata organization
VAICS establishes and maintains a centralized metadata repository that serves as a single source of truth for all clinical data standards. This repository includes metadata related to datasets, variables, controlled terminologies, and value-level metadata, ensuring consistency and ease of access across all clinical trials.
Efficient metadata updates
We ensure that your metadata repository is continually updated with the latest CDISC standards and any study-specific requirements. Our process involves regular reviews and updates to minimize discrepancies and ensure alignment with current regulatory expectations.
Metadata standards implementation
TFL, SDTM, and ADaM repositories
Metadata governance
Standardized processes and procedures
Our metadata governance framework establishes standardized processes for metadata management, ensuring consistency, accuracy, and traceability across all study data. This framework includes clear guidelines for metadata creation, modification, and approval, reducing the risk of errors and ensuring compliance.
Quality control and validation
VAICS implements rigorous quality control and validation procedures to ensure that all metadata is accurate, consistent, and compliant with CDISC standards. This includes automated checks and manual reviews to verify metadata accuracy and completeness before it is used in study documentation or submissions.
Define-XML generation and review
Automated define-XML creation
VAICS uses advanced tools and methodologies to generate Define-XML files that accurately represent your study’s metadata. Our automated processes ensure that Define-XML files are generated efficiently, reducing the risk of errors and ensuring timely submissions.
Comprehensive define-XML review
Before submission, our team conducts a thorough review of the Define-XML files to ensure accuracy and compliance with CDISC standards. This review process includes cross-checking metadata against the study protocol, CRF annotations, and other documentation to ensure consistency and completeness.
Metadata lifecycle management
End-to-end metadata support
VAICS provides comprehensive support throughout the entire metadata lifecycle, from initial creation and implementation to ongoing maintenance and updates. Our approach ensures that your metadata remains accurate and up-to-date throughout the course of your clinical trials.
Historical metadata management
We also manage historical metadata, ensuring that legacy studies are aligned with current CDISC standards where necessary. This service helps maintain consistency across studies and ensures all metadata is readily accessible for regulatory submissions or audits
Training and support deployment (CI/CD)
Why choose VAICS for Metadata Services?
VAICS’s expertise in Metadata services and the development of global standard macros using SAS and R packages ensures that your clinical data management and analysis processes are efficient, consistent, and compliant with industry standards. By leveraging our advanced solutions and comprehensive support, you can achieve reliable, high-quality results and streamline your regulatory submissions.