ZEG Berlin is proud to announce the launch of its Real-World Evidence (RWE) and Safety Data Analytics division. Areas of focus will include Epidemiology, Health Economics and Outcomes Research (HEOR), and Safety, as well as a range of therapy areas. This expansion bridges ZEG Berlin’s classical primary research division with the exciting future of RWE and Real-World Data (RWD).
Dr. Marc Pignot and Dr. Michael Schultze have been appointed to lead the new RWE and Secondary Data division. Dr. Marc Pignot brings more than 20 years of experience in the pharmaceutical and CRO business. He will lead the implementation and development of RWE & Safety Data Analytics. As Chief Strategy Officer, Dr. Pignot will establish a strong secondary data stream to complement and combine with ZEG Berlin’s long-established primary data business. Dr. Michael Schultze is leading the new RWE team focusing on secondary data-driven non-interventional studies. He also leads the development of medical algorithms and the interpreting of big medical data sets. Dr. Schultze’s interdisciplinary experience combines the three essential areas of expertise for secondary data-related studies: medical expertise, advanced project management skills, and a profound understanding of working with RWD.
“By combining decades of expertise and cutting-edge methodology, ZEG Berlin can enrich well-established research approaches with state-of-the-art Real-World Evidence methods. This makes ZEG Berlin a unique bridge-builder between the classical world and the promising future of clinical research,” said Dr. Marc Pignot.
Founded in 1990, ZEG Berlin specializes in the early detection and quantification of safety risks associated with the use of therapeutic, preventative, or diagnostic drugs. ZEG Berlin, part of the Cerner Enviza ecosystem, leverages its many global research associations while continuing to be deeply rooted in the German health sector. ZEG Berlin is best known for the development of the INAS/EURAS direct-to-patient study methodology in the late 1990s that was critical in resolving safety concerns regarding combined oral contraceptives.
“We have assembled a team of scientists and medical specialists at ZEG Berlin who are recognized for their proven achievements in advanced scientific studies and high-level RWE research,” said Dr. Michael Schultze. “The RWE team serves as a trusted advisor to clients, combining scientific research on an academic level with a solid understanding of pharmaceutical business needs.”
ZEG Berlin will build on its long-standing success in classical research methods to combine primary and secondary data in hybrid approaches, offering full services from protocol development to final publication. The design and implementation of innovative RWE tools and services deliver unique access to data and identify new data sources. The integrity of ZEG Berlin’s long history in developing and implementing post-authorization safety studies using primary data remains. However, the addition of sophisticated RWE research and analytics services provides new access to RWD and methodologies essential to meeting the constantly changing requirements, both internally and of regulatory authorities. By this means, ZEG Berlin is very well prepared for the promising future of clinical research and RWE.