Clinical trial center
The clinical trial center (CTC) is an institutional organization of the Ospedale San Raffaele to guide investigators, stakeholders and sponsors in performing clinical research under the highest professional standards.
The CTC coordinates the different aspects related to clinical research and clinical trials activities, providing support at each step of the conduction of the clinical trials, following the Good Clinical Pactices (methodological and statistical guidance, regulatory affairs and executive support, budgeting). The CTC works in compliance to applicable laws, regulations, institutional policies and procedures, and protocols.
The CTC cooperates with the national and international agencies involved in the clinical research process.
Among its core activities:
- Evaluation of the trial design and methodological support for the submission steps
- Budgeting and evaluation of the costs
- Feasibility assessment
- Regulatory issues
- Contracts agreement
- Monitoring and auditing activities
- Data management
- Outcome analysis and final results