COMPANY

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, pharmacovigilance, data cleaning and analysis, and data reporting.
MCR has also internally developed an electronic CRF, compliant with FDA 21 CFR part 11 (named IDAS).
In addition, MCR has an internal Core-lab specialised in QCA analysis.

MISSION

  • MCR offers a comprehensive set of services to provide medical devices and pharmaceutical companies for product development and approval process.
  • MCR has a large experience in investigator-initiated trials and can offer logistical and operational support, scientific and regulatory expertise and training.
  • MCR works in conformity to Good Clinical Practice (GCP) and current regulations. In addition, MCR has developed a set of Standard Operating Procedures (SOPs) which are regularly updated to reflect regulatory environment.
  • Main therapeutic areas of expertise are: Cardiovascular, Neurology (Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s disease, Sleep disorders), Oncology and Psychiatry.
OUR STRENGTH IS ENTHUSIASM.

COMMITMENTS

YOU DISCOVER. WE PROVE IT.
  • MCR designs, develops and performs trials according to high quality standards, employing experienced personnel, with full committment to adhere to the agreed time schedule.
  • MCR has a large expertise in cardiovascular diseases, ensuring high quality clinical cardiology trials.
  • MCR has also expertise in Neurology, Oncology, Psychiatry.
  • MCR is able to develop the design of clinical research protocols and standard or electronic Case Report Forms (CRF).
  • Protocol finalization, project management and trial services are all undertaken according to MCR or Sponsor’s standard operating procedures.
  • Study monitoring and follow-up, from the initial set-up to final reporting, are all fulfilled according to current National and International requirements and by experienced monitors.