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CDISC Services
 
  

CDISC Data Standards Implementation

  • Transform Existing Data to CDISC SDTM Data Models.
  • Verify and Validate Data for Compliance to Data Standards.
  • Manage Metadata of All Standards for Future Implementations.
  • Generate Data Definition Documentation in DEFINE.XML and DEFINE.PDF.
  • Generate Annotated CRF with New CDISC Variables.

CDISC Services

Data standards can make data and its associated programs more portable. Team members working with these standards work more collaboratively and become more efficient. This makes the development and validation of SAS? programs within a regulated environment much more efficient. Meta-Xceed's CDISC service provides your team with expertise on the latest CDISC Submission Data Model. This allows you to submit your data in the proper standards and be fully compliant.

CDISC Compliance and Data Integrity Service 

  • Analyze existing data with CDISC standards
  • Establish and apply data transformation to CDISC standards
  • Evaluate data integrity before and after CDISC models
  • Maintain standards among existing data structures
  • Reconcile interpretations of CDISC standards
  • Generate validated code to perform transformation to CDISC

Prepare Electronic Submission Documentation

  • Capture all metadata for submission data
  • Generate domain documentation (define.pdf) in both PDF and XML formats
  • Maintain updates to documentation as data changes with change control

Data Standards and CDISC Tools Suite
MXI offers comprehensive set of tools for Data Standardization which works effectively with your clinical data analysis/reporting and submission processes. The tools provide you with efficient methods to become compliant with regulatory requirements. This automates the process and delivers data with greater accuracy and integrity.

             
             
  • Sy/Validate - User friendly tools for performing validation and change control of SAS programs.
  • Transdata  - Transdata can be used to efficiently transform your SAS data into standards.
  • CDISC Builder - CDISC Builder is a suite of tools which optimize the creation of your CDISC submission datasets.
  • Definedoc  - Definedoc contains macros and interactive tools which automate the process of documenting your electronic submission datasets.
  • CDISC Reports  - Generate validated code from a library of standard safety summary and listing upon CDISC SDTM and ADaM datasets.

 

 

For more information, please contact MXI .

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Meta-Xceed, Inc. - SAS Consulting, SAS Alliance Partner, Clinical Analytic Software Solutions, SAS Biotech Pharmaceutical Consulting, CDISC Services, CDISC Compliance and Data Integrity Service, Electronic Submission Documentation, SAS System Validation

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