Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
Donawa Lifescience, Italy
Matteo Mosso is Senior Clinical Project Manager at Donawa Lifescience where he has managed and monitored international medical device and IVD clinical studies since 2013. He holds a degree in chemistry from University of Rome ‘La Sapienza’ and has over 20 years’ experience in the conduct and management of clinical studies. Mr. Mosso began his career in the pharmaceutical industry at Merck Sharp & Dohme (MSD), first as a Clinical Research Associate and then as Project Manager, gaining wide experience in several therapeutic areas, including Cardiovascular, Endocrinology, Oncology, Neurology and Psychiatry. Over the nine years he worked with MSD, he managed Phase I to Phase IV drug study projects, including the management and coordination of study teams from start-up to close-out, together with site pre-study inspections, on-site audits, and site follow-up activities. Mr. Mosso subsequently worked at Covance, where he became Clinical Operations / Compliance Oversight Lead on assignment with Pfizer. In this new role he was responsible for in-country project management, oversight, and coordination of international CROs, oversight responsibilities for Phase I to III study monitoring, workload prioritization, study issue resolution, and coordination with corporate, medical, and clinical research staff and key opinion leaders.
Selecting the right site is a key factor in the successful completion of a clinical study and can lead to both short and long term benefits, including early study start, better compliance with the study protocol, high quality data, and lower study costs. This presentation provides a review of the recommended steps for selection of high performing sites, based on actual experience with medical device and IVD clinical studies. The critical relationship between site selection and patient enrollment will also be discussed with the help of case studies. In addition, processes that can be used for selecting sites and improving patient enrollment during the COVID-19 pandemic will also be presented.