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Phase II, III and IV clinical trials
Phase II, III and IV clinical trials
- - Clinical research, clinical data and statistical analyses using SAS
- - Medical writing including clinical study reports (CSR), common technical document (CTD) and manuscripts
- - Data validation including edit check
- - Study Design and clinical trial protocol development
- - Preparation of statistical analysis plans (SAP)
- - Generation and validation of SAS datasets and tables/listings/figures
- - CRF review
- - Support FDA submission including NDA, sBLA, ISS, ISE, and IND Updates.
- - Define.pdf to support FDA submission
