Exposure in clinical domain:
• Good understanding the PROTOCOLS, CDISC Process, SOP's and SAP'S.
• Good Comprehension of FDA and CDISC guidelines, Good Clinical Practice (GCP), International Conference
of Harmonization (ICH)
• Knowledge of CDISC modules like SDTM, ODM implementation and Mapping.
• Knowledge in Maintaining Clinical data in SDTM and AaDM Format.
• The reports were generated and the reports include the following tables as Baseline history and status, followup
visit, time table of patients, laboratory parameters and drug safety reports as per protocols.
Generated Statistical tables using with safety data by the Statistical applications in SAS.