--- title: Profil’s clinical development consulting services description: Profil consulting services are a service to support the professional design and conduct of any diabetes clinical trial. --- [![profil-logo-wortbild-with claim-4c-offset_1000px](https://www.profil.com/hs-fs/hubfs/profil-logo-wortbild-with%20claim-4c-offset_1000px.png?width=250&name=profil-logo-wortbild-with%20claim-4c-offset_1000px.png "profil-logo-wortbild-with claim-4c-offset_1000px")](https://www.profil.com?hsLang=en-us) [![Contact](https://no-cache.hubspot.com/cta/default/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da) [Patient information](https://www.profil.de) # [![Clinical development consulting](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x260px_FurtherServices.jpg?width=1077&height=260&name=Header_1077x260px_FurtherServices.jpg) Clinical Development Consulting Learn about the Profil clinical development consulting services.](https://www.profil.com/services/clinical-development-consulting#) ## The Profil consulting services team supports every step of designing and conducting your trial The success story of Profil is largely based on our unique combination of regulatory knowledge and scientific expertise. Profil was founded in 1999 by medical and scientific experts in the fields of diabetes and metabolic disease, and the team of experts at Profil has been growing ever since. Currently a team of more than 15 consulting experts support our clients in all stages of the development of a new compound. Their area of expertise range from clinical pharmacology (in particular pharmacology of glucose lowering drugs including insulin) over in-depth methodological knowledge (e.g. in stable isotope techniques or cardiovascular assessments) to the fields of nutrition and medical technology. The collaboration of clients with experts at Profil often starts long before the inclusion of the first patient as our experts have drafted numerous clinical development plans and have defended and discussed these plans in meetings with authorities such as FDA or EMA. In addition, our experts usually prepare the essential documents for the submission of a study at ethics and competent authorities, they help the clinical team with the performance of all important study procedures, assist the sponsor with the interpretation of study results and, if desired, present the clinical trial data at international meetings and publish them in scientific journals. We enjoy the scientific discussions with our clients as well as the constant active exchange of scientific topics and ideas with top experts from academia, as indicated by joint publications with key opinion leaders e.g. from the Ruhr-Universität Bochum, the Medizinische Hochschule Hannover and the Medical University of Graz, to name only a few. The ideas developed in these discussions often lead to the next study projects and help our clients to take all the aspects into account that are relevant for a successful development and marketing of their compounds. ![Icon_References](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png) ### Free  Consultation Are you planning a study? Make sure to request your free project consultation now. [![Request now](https://no-cache.hubspot.com/cta/default/481167/3e4e3d1f-5461-4cd2-84e5-24cfae3c671e.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/3e4e3d1f-5461-4cd2-84e5-24cfae3c671e) ![Tim_Hexagon_154x176](https://www.profil.com/hs-fs/hubfs/Mitarbeiter/Tim_Hexagon_154x176.png?width=154&height=175&name=Tim_Hexagon_154x176.png) ### Our expert **Dr. Tim Heise** Lead Scientist [![Contact](https://no-cache.hubspot.com/cta/default/481167/96e42971-e647-4df5-9207-76510d17c7d1.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/96e42971-e647-4df5-9207-76510d17c7d1) ![Icon_NewWebinar](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_NewWebinar.png?width=62&height=70&name=Icon_NewWebinar.png) ### Online Seminar On-Demand Online Seminar: **"First in Human trials - scientific considerations"** [![Watch now](https://no-cache.hubspot.com/cta/default/481167/f2189b6b-0016-4ddf-aa36-e4fb8700130a.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/f2189b6b-0016-4ddf-aa36-e4fb8700130a) ![hans](https://www.profil.com/hs-fs/hubfs/hans.png?width=154&height=176&name=hans.png) ### Our expert **Dr. Hans de Vries** Lead Scientist [![Contact](https://no-cache.hubspot.com/cta/default/481167/3f6ddaea-35ee-4616-bdaf-2db6f28da082.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/3f6ddaea-35ee-4616-bdaf-2db6f28da082) ![Pikto_Testimonials](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Pikto_Testimonials.png?width=81&height=90&name=Pikto_Testimonials.png) ### "What makes Profil special is their extensive experience on the developing of trial protocols, such as the selection of subjects' inclusion and exclusion criteria, the calculation of subject sample size, and the design of evaluation endpoints." **Dr. Chun Shen, CEO, Genova** ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png) #### References We have published with the following sponsors: ![Referenzen](https://www.profil.com/hubfs/BLUE_MOON/content-bilder/Referenzen.gif "Referenzen") [View more](https://www.profil.com/knowledge-center/references?hsLang=en-us) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Certificates.png?width=44&height=49&name=Icon_Certificates.png) #### Certificates | ![13485_Zertifikatssiegel_black_A3](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_134852016_certificate_blue.png) ISO 13485:2016 ![27001_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_27001_certificate_.png) ISO 27001 | ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_9001-2015_certificate.png) ISO 9001:2015 ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/BVMA_Logo_Certificate_size.png) BVMA Member | | --- | --- | ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png) #### Publications Heise, T. et al. 2020. Ultrarapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study. Diabetes Obes Metab. 2020 Oct;22(10):1789-1798. [View all](https://www.profil.com/knowledge-center/publications?hsLang=en-us)   ###### Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9 · 41460 - Neuss, Germany Telefon +49-2131-4018-345 · marketing@profil.com [Imprint](https://www.profil.com/imprint?hsLang=en-us) | [Privacy Policy](https://www.profil.com/privacy?hsLang=en-us)