Profil Institut für Stoffwechselforschung GmbH is a private research institute specialising in high-quality and GCP-compliant clinical-experimental studies in diabetes, obesity and cardio-metabolic disorders.

We offer:

• Scientific consultation - Profil staff, headed by Dr Tim Heise and Dr Bernd Kuglin, has decades of experience in scientific (contract and independent) research in our core competence areas. We have published > 160 peer-reviewed manuscripts and reviews (cumulated impact factor > 350), participate in scientific advisory boards and are involved in discussions with authorities such as the FDA and the EMEA.
  
  
• Timely performance of clinical studies through fast recruitment - We screened approximately 1,000 patients with type 1 or type 2 diabetes in 2008. Our database covers > 2,000 people with type 1 and > 7,000 people with type 2 diabetes and also contains a panel of Japanese subjects for bridging studies.
  
  
• Vast experience even in sophisticated methods such as the glucose clamp - We have done more than 15,000 glucose clamps in the last 10 years and can do up to 12 glucose clamp experiments in parallel. In addition, we have performed numerous GCP-studies in our 35-bed PK-unit with prolonged inhouse-stays of up to 3 weeks using a wide methodological spectrum including, but not limited to isotope dilution technique, adipose/muscle biopsies, calorimetry, body composition, (micro-) vascular structure/function, food intake and metabolic balance studies.
  
  
• Full-service high quality (ISO certified) contract research and a fully licensed, GMP approved pharmacy - We have been ISO9001 certified since 2004 and have successfully passed several inspections, e.g. by the FDA. Our pharmacy can manufacture sterile medication as well as oral solutions and handle bulk in full compliance with GMP. We offer data management, statistics and medical writing at very competitive timelines and have sound knowledge in all relevant data formats, e.g. CDISC.
  
  

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jsechserpack@profil-research.de

lmueller@profil-research.de