Creation of essential study documents
On the basis of the study plan, we prepare further essential study documents (e.g. statistical analysis plan including case number estimation, data protection concept, patient information and consent form, processing list) for submission to the competent authority (e.g. BfArM) and ethics committee.
Cooperation partners and opinion leaders
The right cooperation partners are essential for the success of your study. Thanks to our many years of experience in various indications, we can draw on an extensive partner network of suitable study centers and opinion leaders to recruit the right patients for your study in good time. We are happy to support you in selecting and approaching suitable cooperation partners and take over the complex administration of the contracting process.
To respond to the increasing shortage of resources in clinical study centers, we can bring in additional medical study staff to provide on-site relief.
Study preparation with authorities and ethics committees
We will be happy to support you in preparing talks for consultations with the responsible authorities or take over further communication in the study implementation. We support you in the application process, consultations with competent authorities and the registration procedures for your study.