The Clinical Trial Office (CTO) was established at Centro Cardiologico Monzino (CCM) in 2015 with the mission to provide services to:
- Researchers with assistance on start-up and administration of clinical trials;
- Sponsors with help in identifying CCM investigators suitable for participation in clinical trials.
Main objectives of the CTO are the improvement of the management of the clinical trials conducted at Centro Cardiologico Monzino and the promotion of clinical research, according to Good Clinical Practices.
The CTO offers support to investigators and sponsors with assistance services (project management, statistics etc), personnel and facilities to conduct and facilitate clinical research studies. It provides a centralized point of contact for study budgets, contracts, regulatory affairs and helps to coordinate clinical research studies.
Our clinicians and researchers have extensive clinical and research experience and expertise, that ensure the successful implementation, management and conclusion of cardiovascular clinical trials.
The Project Management (PM) team has years of clinical practice experience.
From the sponsor to the site, our PM is engaged in proactive and regular communication, meetings and conference calls. PM works with all project team members to assure problem identification, resolution and adherence to study timelines.
All this brings a value in clinical practice management and provides essential input into the trial design and valuable suggestions into the feasibility of clinical trials.
Our research contract team develops, negotiates, finalizes research contracts and interfaces with the finance department. The team performs administrative accounting functions for the clinical trials.
Project management’s main activities are:
- Protocol review and feasibility evaluation
- Preparation and submission of regulatory documentation
- Cost evaluation and budgeting
- Monitoring and auditing activities
- Contacts with trial sponsors
The statistics team provides assistance and support to the investigators, reviewing protocols and calculating the most profitable sample size.
The team, in cooperation with the project members, manages the quality control of database, the data coding, reviews the input on Case Report Forms and provides statistical analysis of clinical data. It offers services such as independent validation of results and support for manuscript publications.