Document Writing and Data Analysis

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IND applications/ IMPD
Clinical study reports
Periodic safety update report (PSUR)
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