Data Standardization

SDTM

  • Legacy data to SDTM conversion including ISS/ISE integration
  • Define and SDRG
  • SDTM data validation including conformance and content check
  • Clinical Data Repository (CDR) provisioning

REPORTING

  • Table, Listing, Figure (TLF) Development
  • TLF Validation
  • Patient Profile Creation
  • Data Visualization
  • Ad-hoc Reporting
  • Medical Writing

ADaM

  • Mapping specification for ADaM per SAP
  • ADaM Generation
  • Define and SDRG
  • ADaM data validation
  • Analytical Data Mart (ADM) Provisioning

SUBMISSION

  • Submission document preparation
  • eCTD
  • Submission readiness review