FGK PROVIDES HIGH-QUALITY SAFETY SERVICES AND GLOBAL PHARMACOVIGILANCE SERVICES – GXP- COMPLIANT, SCALABLE AND AUDIT-READY.
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
FIND YOUR DRUG/MEDICAL SAFETY AND PHARMACOVIGILANCE SERVICE PROVIDER
Are you facing increasing operational and regulatory pressure? Rising case volumes, strict compliance requirements and limited internal resources make it difficult to manage pharmacovigilance efficiently in-house. FGK is your reliable partner who can take work off your plate without adding risk. Whether it’s case processing, literature screening, signal detection or QPPV and local safety officer services—we offer a solution that scales with your needs, ensures full compliance, and keeps your systems audit-ready at all times, so you can focus on your core priorities.
Are you looking for solutions to specific safety challenges within your
organization? Whether you’re in Pharma, Biotech or Medtech, the goal is
the same: to build or optimize a safety framework that is both efficient and fully compliant. FGK supports you in gaining clarity: We help understanding what’s possible, what fits your situation best and guide you with expertise, transparency and a deep understanding of your regulatory environment.
Why companies choose FGK:
Experienced team
Work experience spanning clinical development through post-marketing phases, strengthened by a very low staff turnover.
Part of FGK Group
Backed by a full-service Clinical Research Organisation, Data Management, Medical Writing, eSolutions and Regulatory group based in Germany.
Modular & scalable approach
Support that grows with your portfolio and organizational needs.
International perspective
Support on national, international and global levels.
Highly professional
We support companies worldwide in maintaining safe and compliant vigilance systems.
Independent & transparent
Clear processes and high-quality standards established during more than 20 years on the market as owner-driven company.
Zurab Koberidze, M.D., Ph.D., MPH
Director Pharmacovigilance, QPPV
Effective communication is vital for successful outsourcing relationships. We prioritize transparency and collaboration on eye-level, ensuring that you remain informed and engaged throughout the process.