IST is a team of more than 30 physicians, biologists, other academics and paramedics with many years of experience in Clinical Research.
Johan van der Does
Johan joined IST in 2011. He graduated in Pharmaceutical Medicine from the University of Essen and is experienced in Monitoring, Project Management, Proposal Management and Business Administration.
Steffen joined IST in 1992 after 4 years in R&D at a major pharmaceutical company. In addition to knowledge of Medical Writing, Monitoring and Project Management, he acquired expertise in the fields of Pharmacovigilance and Data Management. Since the beginning of his involvement with IST, he has been responsible for the development and maintenance of the quality management system. Since 2009, he has been overseeing quality risk management and has developed a database-driven Quality Risk Management System.
Steffen is president of the German Quality Management Association e. V. (GQMA) and a member of the DGPharMed.
Dr. Kai Mehltretter
Head of Pharmacovigilance
Kai joined IST in 2008 after 4 years in clinical research at a CRO and 5 years of freelance work for the Clinical Pharmacology Department of a major pharmaceutical company. He is author of scientific medical software solutions and experienced in drug safety consulting, review of periodic safety reports, regulatory compliance analyses, reconciliation of safety databases, evaluation and reporting of adverse events from clinical trials, spontaneous reports and published case reports. In addition, he has specific expertise in pharmacovigilance systems and safety data mining. His main therapeutic areas of expertise are Virology and Oncology.
Kai is member of the DGPharMed.
Dr. Bernd Ullrich
Head of International Project Management
Bernd joined IST in 1997 after working as Head of Field Service at a leading provider of biological products. In his role as Project Manager, his responsibilities encompass the management of large trans-national trials (interventional and non-interventional) and involvement in studies on medical devices with coordination of activities across countries, trial logistics and information flow, vendor selection and interactions, monitoring of milestones, budgets and timelines as well as quality control across centers and countries by study guidelines and training of affiliates and investigators. His main therapeutic areas of expertise are Virology and Cardiovascular Diseases.
Bernd is member of the DGPharMed.
Dr. Andreas Kinzig
Head of Study Monitoring
Andreas joined IST in 1999 after employment in Scientific Field Service in Biotechnology and scientific work in oncology (DKFZ, Heidelberg). He has many years of experience in planning, coordination and conduct of all activities with clinical and medical device studies. For over ten years, he has been leading the Study Monitoring Department. His main therapeutic areas of expertise are Cardiovascular Diseases, Virology and Oncology.
Andreas is member of the German Quality Management Association e. V. (GQMA).