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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.
The FDA inspected KAI's pharmacovigilance department in April, 2005 to assure our
compliance with 21CFR 314.80. The outcome of the audit was positive and no FDA 483
was issued.
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.
Fact Sheet
Pharmacovigilance and Clinical Safety
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