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. MCR is well structured and fully staffed to manage projects in full compliance with GCP and applicable regulations. MCR can supports Sponsors and researches in all stages: protocol preparation, logistic organization, regulatory processes, clinical monitoring, data cleaning and analysis, and data reporting. MCR has internally developed an electronic CRF, compliant with FDA 21 CFR part 11.
Staff members
PI
Maria Cristina Jori, MD, MCR Medical Director. She has a degree in Medicine a specialty in Geriatrics and over thirty years of experience in Clinical Research. Prior to joining MCR she acted as global Clinical Project Leader for the clinical development of cabergoline (Parkinson’s Disease) and nicergoline (cognitive impairment) (Farmitalia); later she was also involved in the clinical development of pramipexole in Parkinson’s disease as European Clinical Coordinator (Upjohn). In the field of Dementia she managed clinical trials with new potential pharmacological agents (sanofi).
Member
Bruno Mario Cesana, MD, MCR Head of Statistics & Data management. Prof. Cesana has a degree in Medicine and specialties in Clinical and Laboratory Hematology , Cardioloy and Medical Statistics. From March 2005, Associate Professor of Medical Statistics, University of Brescia. Prof. Cesana has over thirty years of experience in Statistical Methodology for the biomedical research and is the author of several papers and full texts on statistical methodology in clinical trials.
Member
Fabrizio D’Ambrosi, PhD, senior Data Manager. He has 15 years of experience in data management and excellent skills with SAS. His role will be to develop the e-CRF for the project and to supervise data management activities. He will also develop the SAS datasets for the data analysis.
Member
PhD, Clinical Operations Manager. She has a degree in Biological Sciences, with specific focus on Neuromuscular degenerative diseases. Since 2011 she moved to clinical research and was deeply involved in the validation studies of the Italian versions of two rating scales for Parkinson’s disease under the sponsorship of the Movement Disorders Society. Her role will be to design the e-CRF from the protocol, to define risk indicators and to coordinate data management and centralized monitoring activities.
