Fixtest Prüfmittelbau GmbH

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Collaborations FGK Clinical Research GmbH

Heimeranstr. 35 80339 Munich Bavaria 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-rs.com www.fgk-pv.com 190 2002

Full service CRO (contract research organisation) offering a complete range of clinical development and consulting services all over Europe and the US: | 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.

BVMA - Federal Association of Contract Research Organisations

Company overview

FGK Clinical Research is a Europe-based CRO of an ideal size for cooperation with smaller and mid-sized medical device, biotech, or pharmaceutical companies. FGK was founded in 2002 and currently has 190+ employees – most of them located in our headquarters in Munich and our branch office in Berlin, Germany. Covering all phases and areas of clinical development, we have experience in every important medical indication, including in particular 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.

We directly supervise international projects and operate Europe-wide; 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, as maintaining a good relationship forms the basis for long-term cooperation. Our operational team works hand in hand with all other departments involved. 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

Regulatory Affairs › Consulting on regulatory topics › Review of study documents (e.g. protocol, informed consent form, labels) › CTA with submission to authorities and ECs

Clinical Operations › Project management, primary liaison for sponsor communication, status reports, etc. › Feasibility, contract negotiations, site management, monitoring, etc.

Medical Safety/Pharmacovigilance › Adverse Event Management and assessment/reporting › Drug safety, medical monitoring and coding of medical terms › Pharmacovigilance – also visit www.fgk-pv.com

Medical Writing › Investigator’s brochures, study protocols, ICF and subject information › Clinical expert reports, clinical publications, IMP and submission dossiers

Data Management › CRF design and review, clinical trial databases › Data validation, processing and cleaning, external data handling, CDISC SDTM

Biostatistics and Programming › Study design, sample size calculations › Statistical consultancy, analysis plan, programming and reporting › CDISC ADaM

Quality Assurance › Audits of investigator site, database and system audits, internal audits › SOP composition and implementation

eSolutions › eCRF › IWRS/Drug supply › eTMF › CTMS

Visit our website www.fgk-cro.com to learn details about our complete portfolio.