The partner FGK Clinical Research GmbH is a contract research organization which will be responsible for the clinical development and regulatory input for phase I-II studies. The company and its management have a high competence in the clinical development of therapeutic proteins and other drugs.

FGK (www.fgk-cro.de) is part of a Europe-based full service Contract Research Organization with offices in Poland, Germany, UK, Czech Republic and Hungary. It offers the complete range of clinical development and consulting services to biotechnology and medical device companies. FGK has more than 70 highly-skilled and experienced employees working on local and global projects, covering clinical studies Phases I to IV and post-marketing studies. It is active in all major therapeutic areas allowing it to effectively design, manage, and analyze development programs and clinical trials all around Europe.

FGK has handled a lot of different clinical projects over the past years that included a variety of indications and healthy volunteer studies. FGK responsibilities typically include e.g. clinical trial management and monitoring, regulatory submissions, biostatistics, data management, medical writing of protocol, final report etc., quality assurance, pharmacovigilance and consulting services. Some examples of performed studies:

  • A double-blind, placebo controlled, randomized, cross-over Phase I study to evaluate the effect of study medication on ozone induced sputum neutrophilia in 18 healthy volunteers.
  • A blinded, two-part crossover phase I study in 42 healthy volunteers to evaluate the bioavailability and pharmacokinetics of oral liquid and tablet formulations of study medication
  • A phase Ib Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of IMP in Patients 42 patients with Solid Tumours
  • Phase I dose finding trial in 18 patients with advanced head and neck carcinoma

Fore more information, please contact:
Ina Ott
FGK Clinical Research GmbH
Director Business Development
Phone: +49-89-893 119-44
Mobile: +49-172-824 26 94
Email: ina.ott "at" fgk-cro.de