FGK Clinical Research
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. The company was founded in 2002 and has since delivered many great results to its business partners. It is our philosophy not to only closely interact with our clients throughout the project but long beyond it and thus keep the relationship alive for possible future cooperation.
FGK is currently employing close to 100 employees – all very experienced in their respective fields and trained according to the latest standards in clinical research. We take pride in strictly adhering to GCP principles and keeping up with ever-changing national legislations and requirements.
FGK covers all phases and areas of clinical development with special focus on phase II and phase III trials and the disciplines of cardiology, oncology, neurology, dermatology and GIT pathologies. We also provide regulatory support and monitoring/project management for medical devices with or without a CE mark.
FGK’s headquarters are located in Munich but through our subsidiaries in the Czech Republic, Hungary, Poland and UK we directly supervise trials in these geographic areas as well. Monitoring in other European countries and USA/Canada is handled by our long-time partners and local monitors.
Combination of centralized project management operating from Munich and local monitoring as well as local expertise in regulatory submissions ensure timely approvals and efficient trouble-shooting while having a single contact point for Sponsor and receiving whole range of services from a single service provider.
FGK provides a whole range of services – we design your project according to your needs and local practice, help you identify potential investigators, take care of regulatory submissions and contract negotiation and set up effective project management and monitoring of sites, we also perform data management including data collection, data validation, query management and overall biostatistical analysis by means of the latest technological tools and offer medical writing services. Through cooperation with an online solutions provider we offer top-notch electronic management tools and eCRFs. We also provide IT support.
FGK operates according to a regularly reviewed and updated set of SOPs and its quality system is audited on regular basis. Our Quality Assurance department regularly performs audits on behalf of sponsor and assist during inspections from regulatory bodies around Europe.
|FGK Representative Service Ltd., c/o EMW LLP,
Seebeck House, 1 Seebeck Place, Knowlhill, Milton
Keynes, Buckinghamshire, MK5 8FR, United Kingdom
Tel. +44 203 7690905
FGK Representative Service was founded in order to enable sponsor companies with no subsidiary within the European Union to run clinical research projects in the region.
Having a legal representative fulfills the obligation of the sponsor to be established or represented in the European Union. According to European legislation, in order to obtain orphan drug designations and submit applications for drug authorizations the sponsor/applicant must reside in the European Union.
FGK Representative Service can fulfill these duties on your behalf in all member states of the European Union for your drug and medical device trials and facilitate submission of your regulatory applications to the European authorities and ethics committees.
In addition, we can represent you for all your applications for drug authorizations and orphan drug designations. We offer support for you and your local CRO subcontractors who might not be capable or willing to provide the required representation services.
A group of highly experienced regulatory experts at FGK Representative Service will be happy to offer competent, quick and cost-efficient representation services.
Similarly to the European Union requirements, the Swiss clinical trials legislation demands that a sponsor not established in Switzerland assigns a representative based in Switzerland. This requirement applies to clinical trials with both drugs and medical devices.
The official explanatory document of the Swiss clinical trials legislation asks the representative of the sponsor to fulfill the duties of the sponsor. An aid to interpretation from the Swiss Health Agency requires that the sponsor is able to provide any trial-related information when authorities request it. We do offer this service via FGK Representative Service AG, Kreuzäcker 6B, CH-5637 Beinwil (Freiamt), Switzerland, Tel. +41 43 550 71 36.