CDISC Standardization Services

Data Standards are great enablers in improving the quality, efficiency and the cost-effectiveness of clinical research processes. They enrich the portability and accountability of data and its associated programs. Life Sciences organizations are dependent in adopting a sustainable data standardization strategy, at a time where FDA’s guidelines to conforming to CDISC standards are increasingly becoming relevant and important.

 

Element’s CDISC services provide your team with the expertise on the latest CDISC Submission Data Model. This allows you to submit your data in proper standards and be fully compliant with the regulatory norms. We are a CDISC member and our team of senior CDISC consultants possess a thorough understanding and ensure accurate interpretation of ODM, LAB, SDTM and ADaM standards.

 

Business Value
 

  • Accurate interpretation of industry data standards
  • Data accountability at each stage
  • A sustainable data standardization strategy

 
Our Service Offerings:

 

  • CDISC Strategy, Gap Analysis and Business Case preparation including
    • CDISC compliant tool selection
    • Customized CDISC training
  • SDTM, CDASH and ODM compliant database design services
  • Data Integration and Data Mapping services for SDTM compliance
  • Customized ODM Gateway services for external data integration
  • Legacy CDM conversion to achieve SDTM compliance
  • SDTM and ADaM compliant dataset preparation
  • CRT DDS and Define.xml (eCTD) preparation

 

With Element, you can-

 

  • 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
CLIENT EXPERIENCES

 

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