14May Data Integration & Migration No commentsPosted by

  • Planning the analysis for the integrated summaries of safety and efficacy (ISS/ISE)
  • Data integration plan
  • Integration of data sets in any format and from any source
  • Create integrated safety and efficacy datasets
  • Integrated analysis and reporting of safety and efficacy data
  • Case report tabulation data definition document – Define.xml
  • Create and maintain safety databases
  • Data conversion plan
  • Map sponsor defined raw data to SDTM and ADaM domain datasets as well as trial design datasets
  • Case report tabulation data definition documentation – Define.xml
  • Establish a structured workflow and streamlining the creation of SDTM and ADaM deliverables
  • Protocol-defined assessments are mapped with SDTM and ADaM domains to minimize conversion requirements
  • Creation of SDTM and ADaM conformance reports to validate the mapping

Written by

Comments are closed.