Clinical Data Standardization

Developing and bringing a New Product to the Market

Symbiance’s pool of Clinical Data Standardization SME’s help companies leverage CDISC, SDTM and ADaM standard for their internal practices/processes and regulatory submission. We help companies successfully apply CDISC standards , from data collection to eSubmission. Our goal is to bring a unique value-added combination of technology and data standards together in an efficient way from both a time and cost perspective.

Symbiance CDISC Services are

  • CDISC implementation using Alps-ai
  • CDISC SDTM mapping and conversion
  • CDISC ADaM programming and documentation
  • Legacy and ongoing data conversion to SDTM and ADaM
  • The following are achieved using the platform Alps-ai
    • Compliance evaluation
    • Annotation of CRF/eCRF to CDISC -SDTM variables
  • Define.xml, Study Data Reviewers Guide (SDRG) and Analysis Data Reviewers Guide (ADRG) for SDTM and ADaM
  • SDTM Mapping & conversion

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