Experience
Service Scope
  • Create SDTM/ADaM package following eCTD module 5 structure (and non-clinical in Module 4)
  • CDISC compliant SDTM/ADaM datasets(adhering to global/regional regulatoryguidance)
  • Generate define with or without ARMs in xml or pdf format 
  • Develop Reviewer’s Guides and resolve/address SDTM/ADaM compliance issues by utilizing Pinnacle 21 Enterprise
  • Compile and submit plain codes (SAS  program codes) to FDA
  • Global submission supports to comply with TRC (Technical Rejection Criteria)