Maria Anschütz, a pharmacist by training, joined SocraTec R&D in 2002. Together with her team – the project managers and the project management assistants – she is responsible for trial protocol development, project management and reporting. With her penchant for perfection, she is a guarantor for inspection-safe study performance and documentation. Very early in her career she scientifically specialised in the field of drug absorption from the GI tract and thus is responsible for all questions related to Magnetic Marker Monitoring.
Henning Blume, founder and owner of SocraTec and Professor of Pharmacy at the University of Frankfurt, is a highly established expert in the broad field of biopharmaceutics. At SocraTec R&D he is a highly valuable sparring partner for all colleagues when tricky and demanding solutions are needed. But he also supports our clients with highly -sophisticated consultancy activities in SocraTec C&S.
Maren Bruder, pharmacist by training, wrote her PhD thesis in oncology. She joined SocraTec R&D in 2010 and started her professional career as a project manager. She recently took over the responsibility of the project management of all non-interventional trials at SocraTec, bringing her GCP experience in to guarantee adequate standards also in this field. The current European trend, in particular, of realising more and more pharmacovigilance-driven NIS requires such expertise also for phase-IV.
Frank Donath is a pharmacologist and toxicologist as well as a clinical pharmacologist with a university background. During his time in pharmaceutical industry he extended his pharmacological knowledge by comprehensive experience in drug development of the later development stages including phase II and III studies. He joined SocraTec R&D in 2005. Dr. Donath forms the pharmacological and clinical counterpart to the pharmacists in charge of the scientific standard of SocraTec R&D in the Board of Directors. His broad clinical knowledge and his carefully maintained network of medical specialists help finding solutions also for complicated and sometimes even exotic medical questions. Especially for patient studies of early phases his background is of utmost importance. With his pharmacological experience he furthermore contributes to setting standards for clinical trials in early development within scientific organisations in continuous exchange with regulatory authorities.
Cornelius Koch is a trained and experienced specialist for anaesthesia with in-depth experience in critical care and patient care in the perioperative setting. Dr. Koch has comprehensive practical experience as anaesthesiologist gained in different types of hospital care including university clinics. He joined SocraTec R&D in 2013 in order to improve his pharmacological knowledge and to achieve the qualification as clinical pharmacologist. Therefore, he is also involved in pharmacological research at the University of Jena. Dr. Koch is in charge of the Clinical Pharmacology Unit of SocraTec R&D. Together with his team of physicians, nurses and technicians, he is responsible for the practical phase-I -activities of SocraTec R&D.
Barbara Schug, founder and owner of SocraTec and since the beginning managing director of the company, is a pharmacist by training but from the beginning focused on pharmacology to build the bridge between both faculties at SocraTec. Her background very early resulted in including patients in early -phase trials at the SocraTec R&D Clinical Pharmacology Unit and in pushing the development into later stages of clinical trials. She is today actively involved in all study design developments at SocraTec and brings in her broad view and her enthusiasm for methodologically perfect approaches.
André Warnke, a pharmacist by training, joined SocraTec in 2002 as a project manager. Very early it became obvious that his open-mindedness and decision-making courage predestined him for new business fields. Accordingly, he set-up the Brazilian activities of SocraTec R&D and built the path to later phases of clinical trials by establishing a monitoring group at SocraTec. In 2012 he became a management board member and managing director of SocraTec R&D.
Ralph-Steven Wedemeyer, a pharmacist by training, specialised in pharmaceutical technology during his PhD thesis and joined the SocraTec family in 2009. His biopharmaceutical know-how nowadays contributes significantly to the consultancy activities of SocraTec C&S, and consequently resulted in very early high level of interest in pharmacokinetics. Together with Ramon Villalobos-Hernandez and the team at SocraMetrics, he today is responsible for all pharmacokinetic analysis at SocraTec R&D and furthermore heads the company´s department of pharmaceutical technology including the clean-room area at the Clinical Pharmacology Unit in Erfurt.
Melanie Zillig, a pharmacist by training, joined SocraTec right at the beginning. She already worked with Barbara Schug and Henning Blume at the Zentrallaboratorium Deutscher Apotheker and decided to develop the SocraTec R&D and SocraMetrics QA system from the first steps of the company activities. She is highly experienced in GCP and GLP and extended her knowledge to GMP issues related to Annex -13. Together with her team she is responsible for the entire QA- system, all audit activities, the SOP -system and for accompanying all types of inspections by authorities.
For expertise in Data Management, Statistics, IT and EDC see SocraMetrics.