Fördergesellschaft IZB

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FGK Clinical Research GmbH

Heimeranstr. 35 80339 Munich Germany Martin Krauss, Dr Edgar Fenzl +49-89-893-119-0 martin.krauss@fgk-cro.com edgar.fenzl@fgk-cro.com www.fgk-cro.com www.fgk-pv.com www.fgk-rs.com 190 2002

Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services: | Regulatory Affairs | Project Management and Monitoring | Medical Safety | Data Management / Biostatistics | Medical Writing | eSolutions for Clinical Trials | Quality Assurance

FGK Clinical Research has two daughter companies: “FGK Pharmacovigilance” and “FGK Representative Service”, enabling us to offer our clients pharmacovigilance services including services of QPPV and PMSF management as well as legal representation for non-European customers conducting clinical studies or seeking marketing authorisation within the EU/EEA.

European Biotechnology

Company overview

FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and mid-sized biotech, pharmaceutical, or medical device companies. FGK was founded in 2002 and currently has 190 employees – most of them located in our headquarters in Munich, Germany. Covering all phases and areas of clinical development, our focus is on phase II and III trials. We have experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology. Broad knowledge in alternative therapies completes our expertise. Besides our services for drug development, we also help to guide all kinds of innovative medical devices through the increasingly demanding framework of clinical investigations.

Locations

We directly supervise international projects and operate Europe-wide, with staff located in our headquarters in Munich, in our branch office in Berlin, and in our subsidiaries in the Czech Republic, Hungary, and Poland. Our in-house CRAs monitor many European study sites themselves. For additional countries and sites in the US/Canada, we have suitable long-term partners.

Our approach to a project

The main philosophy for FGK is to prepare and conduct studies in close cooperation with the sponsor. Thus, we not only closely interact with our clients throughout the project but long beyond it, as maintaining a good relationship forms the basis for long-term cooperation. FGK is a full-service CRO and can conduct a study from the planning to the final report and beyond. Our operational team works hand in hand with all other departments involved. Distances for internal information flows are very short since most staff is in-house and located in the Munich HQ. This also applies for the project manager, who is the central contact person delivering all required information to the sponsor. Timely approvals and efficient trouble-shooting are achieved through a combination of centralised project management and local monitoring, as well as local expertise in regulatory submissions within the country of study conduct.

Services

Consulting › Advice for drug and device development › Biostatistical support

Regulatory Affairs › Submission › All communication with competent authorities and ethics committees

Project Management and Monitoring › Development of study documents › Study set-up and feasibility › Investigator meetings › Site management & monitoring › TMF handling

Medical Safety › Adverse Event Management and assessment/reporting › Drug Safety, medical monitoring and adverse event coding

Data Management / Biostatistics › CRF design › Data collection, review, and analysis

Medical Writing › Generation and review of entire spectrum of regulatory documents

eSolutions for Clinical Trials › eCRF with integrated IWRS, eTMF, CTMS

Quality Assurance › Regularly reviewed and updated set of SOPs › Quality system audited on a regular basis › Audits on behalf of sponsors › Assistance during inspections

Since 2017, we have been participating in an independent “GCP Qualification Programme”, offering our clients the possibility to obtain an all-encompassing audit report from a third party. Visit our website www.fgk-cro.com to learn details about our complete portfolio.