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.