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Medical Safety

Every project assigned to FGK has the option of full drug safety support from our medical safety experts.

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

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Contact
FGK Clinical Research GmbH
Heimeranstrasse 35
80339 Munich
Germany
T | +49 (0) 89 893 119-0
F | +49 (0) 89 893 119-20
www.fgk-cro.com
info@fgk-cro.com