Profil is the world’s leading diabetes and obesity CRO.
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.
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.
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.
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.