PEGUS has experience with the following services for Integrated Summaries of Safety (ISS):

 

• Analysis of large, public and private adverse event databases:

o FDA AERS and SRS

o WHO

o American Association of Poison Control Centers (AAPCC)

o Drug Abuse Warning Network (DAWN)

• Statistical programming, table and listing generation

• Identification of important safety topics for target medication

• Skilled clinical interpretation and medical writing (PEGUS in-house physician)

• Comprehensive literature review

• Creation and assembly of final report

 

We would be happy to discuss your Integrated Summary of Safety needs.  Please Contact Us for more information.

 

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