CDISC Builder™ - Managing Special Purpose CDISC Domains

CDISC Builder is a suite of tools which optimize the creation of your CDISC submission datasets. Some of the features include:

- Analysis of data and variables with CDISC data models for compliance.
- Evaluate naming conventions and data structures for compliance with CDISC data model guidelines.
- Generate data transformation for Supplemental Qualifiers, Relating Records and Comments data domains for SDTM data model.
- Code generator for specified transformations for validation and batch processing. This also includes code to reverse the transforming data back to source to support existing legacy programs.
- Find relationship between your data and CDISC domains to assist in performing mapping.
- Evaluate similarities between source data and CDISC data models for potential matches to assist in performing transformation to SDTM.
- Creating a metadata database storing transformed data with update and search capabilities for managing standards.
- Generate summary report of all formats used with variables in specified data sets.
- Generate transport files in preparation for DEFINE.PDF and DEFINE.XML .

Suite of Tools
CDISC Builder is part of a suite of tools which can be implemented to provide data for your submission that is compliance to regulatory requirements. This automate the process and delivers data with greater accuracy and integrity

Category:

Travel & Events

Tags:

• CDISC Builder
• CDISC Checker
• Comment Domain
• Findings Domain
• PROC CDISC
• RELREC
• SUPPQUAL
• Relational Records
• Supplemental Qualifier
• Special Purpose Domain
• CDISC Software
• CDISC Tools