Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements

Daniela Karrer is VP, Operations and Clinical Affairs at Donawa Lifescience Consulting (DLC), where she has managed the company’s Clinical Research Organization (CRO) services since 2008 for medical device and IVD studies conducted in Europe and North America. With 20 years’ experience in the life science field, Ms. Karrer worked first within the Italian health service and then for seven years with the Serono Group as a research scientist. She then worked with Covance, one of the world’s largest drug development service companies, initially as a clinical research associate; then as Director, Project Management, responsible for delivery and financial performance of international oncology trials; and, then as Head of the Covance Italian Office and Contract Manager for partners in Greece, Turkey and South Africa. Her last role with Covance was as Director of Clinical Operations for Southern Europe, including Italy, Spain, Portugal, France, Switzerland and Israel. In this role, she was responsible for project resourcing and utilization, target achievement and supervision of the local Clinical Operations Managers, and over 100 staff. Ms. Karrer has a degree in biological sciences from Rome University in Italy.