Mediolanum Cardio Research (MCR)

Mediolanum Cardio Research (MCR) 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 authorisations, project management, monitoring, data management and statistics for sponsored and no-profit clinical trials both pharmacological as well as with Medical Devices. Today main therapeutic areas of MCR expertise are: Cardiovascular, Neurology (Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s disease, Sleep disorders), Oncology and Psychiatry, Infection Disease, Metabolism and Gastrointestinal. MCR has also internally developed an electronic CRF (named IDAS), compliant with FDA 21 CFR part 11, GDPR and EMA  guidelines on computerized systems. 

The Mission of MCR is to offer a comprehensive set of services of logistical and operational support, scientific and regulatory expertise and training to provide medical devices and pharmaceutical companies for product development and approval process.

The role

MCR will support the sites in the start-up phase for preparing the submission package for regulatory and ethics approvals before starting the two clinical studies, the prospective clinical validation trial (WP3) and the randomized clinical trial (WP5). MCR will supervise the RCT protocol and will collaborate with CHINO to guarantee GDPR compliance in the data collection (e.g. Informed Consent Form). MCR will develop the eCRF of both trials, will perform centralized and remote monitoring activity and will take care of the necessary on-site monitoring visits in order to oversee the progress of the study, completion and quality of collected data of the clinical trials. Moreover MCR will provide general support in carrying out the all project planned activities.