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KAI's full service medical affairs department offers post-marketing pharmacovigilance and clinical trial safety reporting support. KAI's medical monitors and drug safety associates:
- Receive, track, assess and follow-up spontaneous adverse event reports
- Conduct literature reviews for reports of adverse events
- Prepare individual case safety reports
- Prepare periodic safety reports
Completed individual case safety reports as well as periodic safety reports are submitted to sponsors and regulatory authorities both within and outside the U.S.
KAI supports pharmacovigilance activities for over 90 marketed drugs and is providing safety surveillance for dozens of ongoing clinical trials.
KAI's pharmacovigilance and safety reporting projects are supported by ARISg™ - a commercial Web based adverse event tracking and reporting system which meets both FDA and ICH requirements, allows for electronic submission of ICSRs in E2B format.
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