Profil Institut für Stoffwechselforschung GmbH
PROFIL is a full-service CRO for early clinical trials focused on diabetes, obesity and cardiometabolic disease. PROFIL provides clients with the scientific and regulatory expertise and all of the services needed to successfully complete clinical investigations into diabetes and its treatment. In addition PROFIL is the develper, manufacturer and distributor of ClampArt®, a European Union approved (CE-marked) medical device using the glucose clamp technology in a closed-loop setting in order to assess the glucodynamic profiles of insulin preparations, the insulin sensitivity as well as the insulin secretion capacity in the setting of clinical investigations.
Role within MELISSA
Work package 4 (Clinical validation)
- Providing expertise & experience in the development and clinical evaluation of diabetes technologies including algorithms informing insulin administration, insulin pharmacology and regulatory affairs.
- Support in the scientific and operational design of the clinical trial.
- Regulatory affairs advice.
Work package 5 (Value proposition, economic analysis, IP, exploitation)
- Competitive landscape analysis.
- Contribution to market penetration strategy.
- Support of needs assessment and value proposition.
Work package 6 (Project communication and dissemination)
- Thematic open source publications related to MELISSA.
- Networking with other EU initiatives including the EIT Health public-private partnership.
- Support of scientific presentations and publications.
