NLSDays 2023German Exhibitors FGK Clinical Research GmbH

FGK Clinical Research GmbH

Booth number: C24
www.fgk-cro.com

About us

FGK provides full service for clinical studies to biotechnology, medical device and pharmaceutical companies.
FGK has been managed by its founders since 2002 and conducts international multi-center studies with hundreds of patients as well as studies in individual countries with only a few patients.

With our 230 highly qualified medical, scientific and regulatory experts, we can provide services of the highest quality while guaranteeing a personalized and flexible approach to our clients.

We offer partial or full services for your clinical trials, including:

  • clinical trial management and clinical monitoring

  • regulatory submissions

  • biostatistics

  • data management

  • eSolutions

  • medical writing
  • medical safety

  • pharmacovigilance
  • consulting services

  • EU legal representative

Address

FGK Clinical Research GmbH
Heimeranstr. 35
80339 Munich
Germany

Phone:  +49 89 8931190

Contact person:

Martin Krauss
Managing Director
E-mail: martin.krauss@fgk-cro.com

Ursula Türcke
Senior Director Clinical Operations
E-mail: ursula.tuercke@fgk-cro.com

Products & Services

Services
Pharmaceuticals
Biotechnology

FGK provides full service for clinical studies to biotechnology, medical device and pharmaceutical companies. Owned and managed by its founders since 2002, FGK is conducting international multi-center studies with hundreds of patients as well as single country studies in Europe with only few patients.

With our 230 highly qualified medical, scientific and regulatory experts, we can offer highest quality services while guaranteeing a personal and flexible approach for our clients.

Full service or partial services for conduct of clinical trials including:

  • clinical trial management and clinical monitoring

  • regulatory submissions

  • biostatistics

  • data management

  • eSolutions

  • medical writing

  • medical safety

  • pharmacovigilance

  • consulting services

  • EU legal representative

CRO services for clinical studies

Full or partial services for conduct of clinical trials including:
* clinical trial management and clinical monitoring
* regulatory submissions
* biostatistics
* data management
* eSolutions
* medical writing
* medical safety
* quality assurance
* pharmacovigilance
* consulting services
We have experience in all phases and important medical indications, including oncology, cardiology, neurology, dermatology, and gastroenterology as well as in alternative therapies (ATMPs, Cell and Gene Therapy)
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Representative Services

Legal representation for non-European customers conducting clinical studies or seeking marketing authorisation within the EU/EEA.

• Clinical Trials with drugs
• Clinical Investigations with medical devices
• ORPHAN MEDICINAL PRODUCTS (DRUGS)
• Marketing Authorization
• SME Status
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Pharmacovigilance

Vigilance services in support to pharmaceutical, biotech, and medical device companies obligations in managing risk-benefit profile of their products. Our services can be added to existing vigilance system of a client on a modular basis or comprise a stand-alone center of product vigilance on national, international or global level.
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