FGK Clinical Research
FGK approaches each project, whether large or small, with dedicated, highly motivated, small teams and a full commitment to achieving and even exceeding your objectives.
FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and middle-size biotech, pharmaceutical or medical device companies. We are currently employing close to 100 employees – all very experienced in their own fields and trained according to the latest standards in clinical research.
|FGK Clinical Research|
|Type||Public / Private|
|Headquarters||35 Heimeranstraße München, Bavaria 80339 German|
FGK Clinical Research GmbH was founded
Foundation (75 %) of FGK Representative Service GmbH
Co-foundation (50 %) of a Czech-CRO Avemedica (Prague), covering Czech Republic + Slovak Republic
Opening of an affiliate in London, UK (FGK Clinical Research Limited)
FGK became major shareholder of the Czech CRO Avemedica s.r.o. which now operates as FGK Clinical Research s.r.o.
Foundation of FGK Clinical Research Kft. in Budapest by takeover of an existing Hungarian CRO
Set up of FGK Pharmacovigilance GmbH
Opening of an affiliate in London, UK: FGK Representative Service Ltd.
- Regulatory Affairs
- Project Management/Monitoring
- Data Management/ Statistics
- Medical Writing
- Quality Assurance
- Medical Safety
Professional advice for efficient product development
Product development without any unnecessary delays is the dream of every biotech or pharmaceutical company. FGK is well aware of that and considers this central factor with utmost importance. We spend long enough time on pre-planning stages; only then will your project run on time and on budget.
Many of our personnel have worked in large pharmaceutical, small biotech companies, and everything in between. We speak your language and are very eager to help you with any clinical, regulatory, or biostatistical issue that may arise in the course of product development.
We know the local peculiarities of almost all European regions and are able to avoid misunderstandings by providing tips and suggestions that might not have occurred to you. This is why our professional advice is sought by clients worldwide, many of whom we helped co-develop new medical devices, compounds, drugs and biotech products.
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