Quality not quantity – obtaining your own clinical data both before and after market launch not only serves to meet regulatory requirements, but also to ensure the success of your company and, above all, serves your users and patients. An individual and practical concept based on the device and its design is indispensable for every study. What makes a well planned study? A good study must provide reliable answers to important clinical questions with as little effort as possible. We therefore clarify the study objectives and endpoints with you and develop a study design that allows data to be collected efficiently. This makes evaluation easier and avoids queries from the authorities. In order to obtain the approval of the authorities and/or the ethics committee(s), the required documents must be submitted and consistently followed up. The effort necessary before a clincal trial can be started is often underestimated, both in scope and duration.
Getting ready for the first patient: We support you with help and advice to meet regulatory requirements. As part of project management, we monitor the adherance to milestones and coordinate communication between all stakeholders of your study – from start to finish. It goes without saying that we comply with the requirements of ISO 14155 and DSGVO.
- Development of the study design in close cooperation with you and doctors/users
- Preparation of study documents such as synopsis, study plan, investigator brochure, patient information and informed consent
- Submission of application documents to authorities and/or ethics committees
- Communication with authorities and/or ethics committees
- Creation and maintenance of the Trial Master File (TMF)
- Development of various reports during the study, e.g. interim evaluations, safety reports, final report, support in publishing
We provide tailored support to meet your needs, whether it is a clinical study for a declaration of conformity of a medical device or a PMCF measure in as a part of post-market surveillance (PMS).
Phone: +49 7071 98979 - 139