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Clinical Trials Center

The CTC supports Clinical Researchers in managing many aspects of investigational clinical studies, such as study design and statistical validation, submission to the Ethics Committee and regulatory authorities (AIFA for Phase I studies), budget and contract related issues, as well as data management and statistical analysis, thanks to data managers, medical statisticians, and an administrative and specialist. The CTC also provides pharmacovigilance through “ad hoc” trained pharmacist, employs qualified Research Nurses to improve patient care in the various steps of the study (scheduling of treatments, blood sampling, exams, controls, etc.), and laboratory biologists to handle tissue and blood samples for pharmacokinetics and molecular studies. The CTC works through validated and updated SOP and electronic CRF customized for each study; personnel education and training is coordinated by the Scientific Directorate.

The CTC is also improving the organization of sponsored clinical trials, speeding up administrative processes, budget definition, patient recruitment and data management, organizing a centralized record of all radio-diagnostic exams, and assisting Clinical Monitors in their visits. 
 

 
 
 

Ultimo aggiornamento: 15-09-2017 10:03:55

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