Safety Data Analysis and Document Writing

• IND applications/ IMPD
• Clinical study reports
• Periodic Benefit-Risk Evaluation Report (PBRER)
• Periodic adverse drug experience report (PADER)
• IND annual and EU Annual Safety Reports
• Developmental safety update report (DSUR)
• Document preparation for data
• Monitoring committees (DMC) and event review/ adjudication committees
• Patient narrative writing
• NDA, BLA and MAA document writing
• Cumulative safety data analyses: integrated summary of safety (ISS), summary of clinical safety, and postmarketing datasets