Over 25 years of clinical trial experience
Founded in 1999, Profil is a unique full-service CRO with an excellent record for professional conduct and scientific expertise in clinical research on diabetes and other metabolic diseases.
The Profil Institut für Stoffwechselforschung GmbH (in English Profil Institute for Metabolic Research), began life as a spin-off of the Department of Metabolic Diseases and Nutrition at the
University of Düsseldorf. Our founders wished to create a dedicated CRO that would address the challenges of diabetes and obesity research and treatment. The company’s achievements are a testament to that vision.
Over the years, we have implemented numerous sophisticated methods for
pharmacodynamic characterization of the effects of compounds in early phase trials, and we have been involved in the development of all the currently available major anti-diabetic compounds. Our key competence is the performance of
glucose clamp studies, often combined with isotope dilution techniques and muscle or fat biopsies.
Full-service support for clinical trials
Profil is a full-service CRO certified according to ISO 9001:2015 and ISO 13485:2016. We can boast a vast patient database, with over 30,000 people, a dedicated regulatory department, a fully GMP-certified pharmacy and an in-house clinic in Neuss. This clinic has 65 beds. Thus, we can reliably perform clinical studies within agreed timelines.
In addition to excellent facilities, we provide a unique combination of regulatory and scientific expertise to support clinical trial goals. Our team has over 330 members, including 20 physicians and 1 specialist with a master’s degree in drug regulatory affairs, and our scientific experts are internationally renowned for their contributions in the fields of diabetes, pharmacology, obesity, prediabetes, cardiology, nutrition, and medical technology. This team has to its name over 400 peer-reviewed publications and a significant presence at international diabetes-focused conferences.
Early phase trials in diabetes and obesity development
With a focus on early phase studies, we pride ourselves on aiding our clients to design the very best clinical trials: optimum participant groups and test environments, best-fit methods, and support for analyses and dissemination of results.
We have considerable experience in working with large pharmaceutical companies that are used to moving compounds through their pipelines as well as small and medium companies who may be working on their first clinical candidate. In our work, we adjust to the needs of the different types of clients. What stays the same is our unrivalled expertise in our core areas of specialization:
Pharmacodynamics and pharmacokinetics
We have experience with testing all classes of new and modified anti-diabetic drugs with regard to their pharmacodynamic and pharmacokinetic effects using methods such as glucose clamp, isotope dilution techniques, and muscle or fat biopsies.
Safety and tolerability studies
Safety and tolerability studies for novel compounds are a core expertise for Profil, making us an ideal partner for first-in-man studies and single or multiple ascending dose studies focused on diabetes or obesity treatment.
Bioequivalence trials
We’ve performed numerous bioequivalence trials with different insulin formulations and can advise on optimization of study design to ensure that regulatory requirements of the FDA and EMA are met.
Bridging studies
Data from clinical trials performed at Profil are used and accepted by the authorities for NDAs in Japan. Accelerate your approval process in Japan considerably (from an average of 56 to 32 months) by doing your bridging study with us. We have Japanese staff members to run these studies and our database has 300 Japanese volunteers and can easily be extended.
Technology studies
We’re experienced in all aspects of medical technology in the area of diabetes and obesity. We played a leading role in the development of the artificial pancreas and we have a dedicated team for medical device projects. Profil is ISO 13485 certified and has substantial regulatory experience in medical technology trials, including the recent MDR.
