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