Standardization and Compliance to the FDA eSubmission Requirement

• Customized patient profiles
• Annotate the CRF for SDTM 
• Create CDISC SDTM and ADaM datasets
• Pinnacle 21 Check and compliant
• Preparation of Reviewer’s Guide SDRG, Analysis Data Reviewer’s guide (ADRG)
• Create define.xml for SDTM datasets and ADaM datasets
• Create Tables, Figures and Listings (TFLs) with .RTF, .PDF, .sas7bdat format via SAS Programmings using the FDA recommended linear process 
• Development of Bioresearch Monitoring Program (BIMO) Listings

Preparation of the Statistics Package in the FDA eSubmission-ready format

• Check datasets for compliance to the FDA eSubmission requirements
• Create metadata and outsource data in SAS Xport format for all studies
• Create the folder structure per eSubmission requirement
• Copy SAS datasets, aCRFs, SDRG /ADRG, define.xml, and sas programs (ie, .txt file) into the respective folders