YOUR CRO

FLEXIBLE EXPERTS &
RELIABLE SOLUTIONS

In clinical research, smallest details matter. Our commitment is to highest standards in quality, service and client confidentiality.

Pharmacovigilance

Minimizing Risks for maximum Benefits.

Keeping a watchful eye on the safety of your products, we collect and report your safety data. Because safety comes first.

Representative Services

Your Premium European Legal Representative.

Operating in all of the European Union and Switzerland, we are your link to successful business throughout Europe.

About FGK

We are a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies.

Meet us

FGK is attending DBT in Wiesbaden, Germany.

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News

One year after its launch, the CTIS portal suffers from serious deficiencies, severely impairing the application procedure for clinical studies in all of Europe.

Since end of January and after a one year transition period, approval for new clinical trials of medicinal products in Europe can only be…

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Our experience spans multiple fields of medical indications.

Expertise

  • Medical Devices

    The medical device sector presents with an extremely broad spectrum of continuous innovation, including hundreds of different technologies and a whole universe of types of products in the fields of prevention, diagnosis, therapy, after-care, rehabilitation and nursing care. At the same time, regulatory requirements for placing medical devices on the market, and thereby the need for clinical data, will become substantially more demanding.

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  • Advanced Therapy Medicinal Product

    Our experienced team of specialists has broad knowledge in clinical studies with advanced therapy medicinal products.

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  • Oncology

    In the constantly evolving field of developing oncological therapies we support our clients with our well trained and experienced team that has completed numerous clinical trials spanning a broad variety of indications with an excellent site relationship and knowledge of successful strategies even in most novel therapy fields.

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  • Neurology / Psychiatry

    Neurological disorders are diseases of the central and peripheral nervous system. In other words, the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscles. Mental disorders, on the other hand, are "psychiatric illnesses" or diseases which appear primarily as abnormalities of thought, feeling or behavior, producing either distress or impairment of function. Interventions for neurological disorders include preventative measures, lifestyle changes, physiotherapy or other therapy, neuro-rehabilitation, pain management, medication, or operations performed by neurosurgeons.

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  • Dentistry

    Today’s clinical trials in the area of dental research have broader ranges than only implant and material studies. New challenges came up, such as bone healing and tissue regeneration studies. In addition, GCP knowledge is not profound and widespread among dentists. This can be overcome by an experienced CRO partner who knows that special training and intensive site support is essential in this clinical development area.

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  • Cardiovascular

    Our specialist team is experienced in the different methodologies related to the management of cardiac and vascular disorders. This includes interventional cardiology, cardiothoracic surgery and cardiac rhythm management etc. and developing products like (drug coated) stents, (drug coated) balloons and ablation systems. Also gene and polymer based therapy in this field is part of our competence including the management of regulatory hurdles, dealing successfully with the complex on site training of physicians and providing close monitoring of the study sites.

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  • Infections

    Infections can have various sources and affect most of the human organs. FGK has a diversified range of experience in the development of anti-infectives including anti-bacterials, anti-virals and anti-fungals. Also vaccine and other preventive approaches are part of our portfolio.

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  • Ophthalmology

    We design and execute clinical studies, and innovate development programs in a broad variety of ophthalmic indications.

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  • Pneumology

    The high quantity and diversity of trials in the area of pneumology, especially in COPD and asthma, result in more and more professionalized study sites. FGK has established a good network with such investigational sites to assure fast recruitment and adequate special measurements as spirometry, ozone challenge or sputum and biomarker analyses.

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  • Gastroenterology

    Based on many years of comprehensive experience in the design and conduct of clinical trials in various gastroenterological indications we can provide sound advice and service in every stage of your clinical development. Our experience in gastroenterology embraces the following conditions:

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  • Gynecology / Urology

    In addition to gender specific oncological indications our team is experienced in conducting studies also in the field of classical indications of gynecology and urology.

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  • Endocrine / Metabolic Disorders

    Our experienced team of specialists allows us to effectively design, manage and analyze your development programs and clinical trials in the highly diversified field of endocrine and metabolic diseases.

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  • Dermatology

    Modern imaging techniques are one of the key tools in evaluating efficacy endpoints in dermatological studies. FGK has established cooperation with technical service providers and dermatological experts in various indications, to ensure straight forward image processing and evaluation.

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  • Rare Diseases

    Not only due to a limited number of patients and qualified study sites, orphan disorders require unique approaches in study conduct. Knowing the exceptional challenges, we handle these projects with profound understanding of Orphan Drug Development.

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Contact Us

FGK Clinical Research Kft.

Tölgyfa u 14
1027 Budapest · Hungary

T: +36 1 209 2668
F: +36 1 273 0277

info@fgk-cro.hu