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