Pharmacovigilance

Your specialists in minimizing risks

Pharmacovigilance or safety monitoring means collecting every single clinical adverse event that occurs during your study. That mass of data, while obviously needing to be reported verbatim, also needs to be understood. Only then can hazard reduction and appropriate product labeling be designed.

We can use any of the internationally-agreed coding systems that you may prefer, and we know how to analyze this type of data. We are fully compliant with regulatory reporting according to adverse event seriousness, investigational product attributability, appropriate defaulting to the most conservative assessment, and the timelines that govern those processes.

Regular safety reports are submitted to applicable authorities and safety notifications distributed to all involved parties. Our physicians also serve as advisors to investigators, who can reach them seven days a week and discuss any questions or issues.

Should you like to profit from our focused knowledge of authorities on both sides of the Atlantic, time-proven safety experience and a steady hand, please visit www.fgk-pv.com for more information.

What we do in the Pharmacovigilance department

We monitor studies with regard to safety of medicinal products
We code adverse events and concomitant medication according to MedDRA and WHO drug database
We assess and understand observed adverse events
We report applicable events to regulatory authorities and ethics committees and compile safety reports (DSURs)
We communicate with Drug Safety Monitoring Committees and investigators