Clinical studies for e.g. dialyzers
We conduct clinical studies for medical devices such as hemodialyzers from designing the clinical study protocol to writing the final publication. We are specialized in generating clinical data for medical devices without CE mark according to the EU Council Directive 93/42, the MPG (“medical product act”) and the MPKPV (“ordinance on clinical studies of medical devices”) in Germany. Our services include:- Designing of the clinical study protocol
- Applying for approval at the IRB (ethical committee)
- Consulting service for the documentation of the basic requirements
- Act as authorized person according to MPG
- Communication with BfArM and the local government (the competent authorities) in Germany
- Organization of the clinical study
- Providing sample tubes and other materials to the clinic
- Plasma sample collection from the patient
- Analyzing samples in our laboratory
- Statistical data analysis
- Writing a study report
- Preparation of a presentation or a manuscript for publication in „peer-reviewed journals“
Beside the close co-operation with a modern, local dialysis center, eXcorLab provides the opportunity to co-operate with opinion leaders in several university clinics throughout Europe.