Heike Schoen is the Managing Director and Co-Founder of LUMIS International GmbH, headquartered in Germany. With her company she has specialized to support Biotech and Medical Device companies to implement clinical processes to cope with the regulatory requirements to perform effective oversight management of their clinical trials. The company also offers legal representation for non-European Sponsors. She has worked in leading positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post marketing activities as well as business development within contract research organizations (CROs) and the biotechnology industry. Her previous positions included operational and general management in clinical research. She holds a master’s degree in psychology and a master’s degree in business administration.
Transition from pre-clinical to clinical development, optimizing clinical research processes through effective vendor selection and oversight management of clinical trials