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)
