Every project assigned to FGK has the option of full drug safety support from our medical safety experts.
Medical Safety
What we do in the Medical Safety department
We design, set up and manage safety processes and safety documentation of a clinical trial
We conduct necessary safety trainings of a sponsor, project monitoring team and/or trial site staff
We offer services of a medical monitor, available to answer questions of study site staff, patients and/or a sponsor of a clinical trial
We receive and process serious adverse event (SAE) reports from a clinical trial
We medically assess and evaluate the reportability of SAEs, including writing of narratives
We conduct Analyses of Similar Events (AOSE)
We prepare and submit reportable events (SUSARs) on an expedited basis (CIOMS/MedWatch) to competent authorities, ethic committees/institutional review boards and investigators
We offer services of a Person Responsible for Eudravigilance with all related mandatory registrations tasks
We set up, populate and maintain clinical trial safety database
We standardize adverse event/medical history terms and study/concomitant medications by using Medical Dictionary for Regulatory Affairs (MedDRA) and WHO Drug Dictionary
We set up and manage the SAE query process
We perform reconciliation of safety and clinical databases
We develop and submit periodic safety reports (DSUR) to competent authorities and ethic committees/institutional review boards
We provide ongoing and periodical assessment of the risk benefit balance of an investigational product
We monitor and report urgent safety issues
We support Data Safety Monitoring Boards with safety information
We provide additional country specific safety reporting services