Thinki aggregate reporting team has expertise in reviewing and writing aggregate reports as per the relevant regulations in a cost efficient and timely manner. Some of the reports we write are:
Periodic Safety Update Reports (PSURs)
Periodic Benefit Risk Evaluation Reports (PBRERs)
Addendum Reports, Annual Safety Reports (ASRs) and Summary Bridging Reports, where needed
Periodic Adverse Drug Experience Reports (PADERs)
SUSAR Reports
Development Safety Update Reports (DSURs)
