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We conduct clinical trials according to the directions of EU regulation (EU) 2017/745 MDR, (EU) 2017/746 IVDR and the Medical Device Law Implementation Act (MPDG). We pay attention to fulfill all additional applicable national and international laws and guidelines as well as ISO standards like the DIN EN ISO 14155:2020 in the area of medical devices and the ISO 20916:2019-05 in the area of in-vitro diagnostics.
We adhere to the principles of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), GCP as well as to the recommendation of the world medical association regarding the ethical principles for medical research including medical subjects (declaration of Helsinki).
Both the preparation (including conception, and submission to authorities and ethic committees) as well as the conduction and evaluation of clinical trials (both in- and outpatient) with medical devices and in-vitro diagnostics are our core competences. Our team of qualified and experienced project managers and study physicians has been supporting our customers for more than 20 years in all study-related activities, starting from the planning, preparation and conduction of clinical studies up to analysis of the results, reporting and subsequent publication in international journals.
The development of the project design, the flexible configuration and possible changes are all done in close collaboration with our customers.
Our broad subject database, our linkage to medical practices and hospitals specialized in diabetes enable us to perform clinical studies efficiently. We are always aware of our responsibility for our study participants and will never lose sight of their well-being.
We conduct clinical studies regarding different questions in the area of diabetes mellitus, diabetes therapy and diabetes technology:
CGM systems are medical devices to continuously measure tissue glucose in people with diabetes mellitus. The manufactures have to provide results from clinical studies that prove that their devices meet the performance requirements for their intended use. In addition they must not pose any risks or dangers to users, meaning the essential safety and performance requirements (according to appendix I, MDR) must be met and evidenced.
We have been conducting clinical studies for the evaluation of CGM systems for many years. Depending on the study objective, we produce data that can be used by the manufactures for prove of effectiveness and safety of the system to be tested or for advancement / optimization of its algorithm. The study design is always dependent on the aim of the study, up to now there is no standard for test procedures available. We offer different reference methods to evaluate the accuracy of the systems. In addition, we have established reliable procedures which enable us to cover a wide range of glucose values. Due to our long-standing expertise with CGM systems and their testing, we belong to the world’s experts in this field and stand for scientific valid, efficient and high-quality study conduction.
We are accredited by the Deutsche Akkreditierungsstelle GmbH (DAkkS / ILAC) and recognized as a test laboratory by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) according to DIN EN ISO/IEC 17025 and the guideline 98/79/EG for examinations according to DIN EN ISO 15197.
We can also provide blood glucose meter tests beyond ISO 15197. Feel free to contact us.
Non-invasive systems for glucose measurement, which can be used without skin damage, are a possible alternative for blood glucose meters or CGM systems. The manufactures must prove in clinical studies that their devices fulfil the requirements and purposes which they are intended for. In addition they must not pose any risks or dangers to users, meaning the essential safety and performance requirements (according to appendix I, MDR) must be met and evidenced. The clinical evaluations can be performed similar to the studies for CGM systems. Again, the design of the study is dependent on the aim of the study.
Besides blood glucose meters, we also test further in-vitro diagnostics surrounding the field of diabetes mellitus, for example systems to measure HbA1c.
Digital health applications (DiGA) are medical devices whose main function is based on digital technologies, for example apps. In Germany, DiGA which are listed in the directory of the Federal Institute for Drugs and Medical Devices (BfArM) can be prescribed by physicians and accordingly be reimbursed by health insurances. In order to be listed in the DiGA-directory, the devices need to have at least one proven benefit in addition to the necessary CE mark.
For this, a clinical study is necessary which can either show the medical benefit or an improvement of a patient associated structure or process. Design of the study is dependent on the patient group and the indication of the DiGA and the study must be performed explicitly in Germany. We support our customers in planning and performing their DiGA studies, and are happy to do so also in combination with a clinical evaluation.
Insulin pumps are a technical device for continuous infusion of insulin. Unlike insulin syringes or pens, they are permanently worn on the body. We can test in clinical studies variable aspects such as the safety and the tolerability of insulin pumps on human beings.
Besides our main focus on diabetes mellitus, we conduct studies with additional medical devices, for example:
To improve the reader-friendliness of our website, we use the generic masculine. In the context of equal treatment, we would like to point out that the content of our website is aimed at all genders and does not contain any valuation.