Project management

What makes a well-designed study?

For every study, an individual and practice-oriented concept, based on the product and its intended use, is indispensable.

A well-designed study reliably answers clinical questions with minimal effort. To achieve this, we define the study objectives and endpoints with you and develop a study design that allows efficient data collection. This facilitates analysis and avoids follow-up questions from authorities. Submitting the documents to the ethics committee(s) and, if necessary, the federal authority requires care and consistent follow-up to obtain the favorable opinion of the ethics committee(s) and, if applicable, the approval of the federal authority, so that the clinical study can start on time. The scope and duration of this process are often underestimated.

Getting ready for the first patient

We are at your side with advice and support to implement the regulatory requirements tailored to your project. As part of project management, we monitor the adherence to milestones and coordinate communication between all stakeholders from the beginning to the completion of the study. For us, it goes without saying that we comply with the requirements of the MDR, MDCG documents, ISO 14155, and GDPR (General Data Protection Regulation).

Development of the study design in close collaboration with you and the intended users
Submission of application documents to ethics committees and, if applicable, the federal authority
Communication with ethics committees and the federal authority
Creation and maintenance of the Trial Master File (TMF)
Preparation and dispatch of the Investigator Site File (ISF)
Review and adaptation of existing investigator agreements, drafting of new investigator agreements, support with contract negotiations and the signature process
Safety notifications