Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
Donawa Lifescience, Italy
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.
A Clinical Investigation Plan (CIP) is the foundation of the complex activities involved in managing a clinical study with a medical device. It is the same for a Clinical Performance Study Plan (CPSP) when IVD clinical performance studies need to be managed. This presentation will address important aspects of the regulatory requirements for CIPs, as specified in EN ISO 14155:2020, and CPSPs, in EN ISO 20916:2019. In addition, examples of recurring issues concerning CIPs and CPSPs, which can lead to delays in study approval or create unnecessary workload, will be presented. Also, recommendations will be made for transforming CIPs and CPSPs into useful tools for successful study implementation.