STATKING medical personnel work to ease the burden of medical monitoring for
your internal staff by providing the following drug safety reporting services:
-
AE and SAE evaluation
- SAE Narrative Writing
- Literature Reviews and Summaries
- Preparation of Med Watch 3500A/CIOMS forms
- Preparation of Periodic Safety Update Reports (PSURs)
- Preparation of Periodic Adverse Event Experience Reports (PADERs)
- Notification of potential expedited IND, alert and suspected unexpected serious adverse reactions
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