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 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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