Dr. Lücker - Rechtsanwalt - MP Recht

Clinical research

Clinical data represents the key element in the clinical evaluation without which no medical device may be brought onto the market. But are clinical investigations needed to generate the data required or will observations in use or preclinical data be sufficient? The approval procedure for clinical investigations may also be extremely complex; experience with and understanding of the authorities and ethics committees involved may be decisive. We have supported manufacturers and sponsors for more than 15 years in the planning, approval and implementation of clinical trials and therefore not only have excellent contacts with well-known CRO’s and other clinical advisors but also continuously represent our clients towards German local authorities and BfArM (the German Institute for Drugs and Medical Devices) as well as other European competent authorities. Our reputation as a competent, solution-oriented partner is unique.