 | Emergency notification system (24 hours a day, 7 days a week)
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| Management and follow-up of serious adverse events (SAEs)
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| Prompt SAE notification to clients
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| Creation of CIOMS lists (in line with the guidelines of the Council for International Organizations of Medical Sciences)
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| Notification of Suspected Unexpected Serious Adverse Reactions (SUSARs) to authorities and Ethics Committees
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| Coding (using e.g. the Medical Dictionary for Regulatory Activities, MedDRA)
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| SAE database including full audit trail
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| Interim safety analyses
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| Integrated Summaries of Safety (ISS) |
