16 - “The role of a CRO in the management of a clinical trial: what we do today and what we could do tomorrow in an evolving scientific world“
Host: Maria Cristina Jori
Medical Director, Mediolanum Cardio Research
Medicine & Surgery PhD at University of Milan
The roles and the rules that a Contract Research Organisation (CRO) has to adhere to in the context of clinical trials are clearly defined in the Regulation in force and by several guidelines. What will be the role of a CRO in the context of in-silico clinical trials is speculative and there is a need to adapt the current regulatory framework to accommodate future scenarios.
Maria Cristina Jori will present MCR's current experience in “real” clinical trials and will share their view of the future”.
Maria Cristina Jori has a degree in Medicine a specialty in Geriatrics and over thirty years of experience in Clinical Research.
She coordinates the MCR team in supporting the validation studies of the Italian versions of two PD rating scales; prior to joining MCR she acted as global Clinical Project Leader for the clinical development of cabergoline (Farmitalia); later she was also involved in the clinical development of pramipexole as European Clinical Coordinator (Upjohn).
Mediolanum Cardio Research (MCR) Srl is an independent Contract Research Organisation (CRO) established in Milano (Italy). MCR was founded in 2002 with the aim of supporting no-profit research projects developed by a group of interventional cardiologists. Since then MCR have gained extensive experience as Clinical Research Organization providing services for regulatory authorizations, project management, monitoring, data management and statistics for sponsored and no-profit clinical trials both pharmacological as well as with Medical Devices.
