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Adverse event management for clinical trials and in-market products |
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Receipt, processing and narrative generation of serious adverse experiences, pregnancies and endpoints |
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Assessment and evaluation of reportability and submission of reportable events to appropriate regulatory authorities |
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Coding (MedDRA) of adverse event information |
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Preparation and submission of safety reports (CIOMS/MedWatch, DSURs, PSURs, etc.) to regulatory authorities |
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Medical monitoring |
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Notifications to investigators (Dear Doctor letters) |
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Drug Safety Monitoring Board functions |
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Legacy safety data entry |
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Support of Drug Safety Monitoring Commitees (DSMB) |
