Societatea Civila Medicala Dr. ROSU is a private primary care clinic specialized as CLINICAL RESEARCH UNIT. It is legally authorized by the Romanian Ministry of Health to perform clinical research in the following specialties:
All clinical research activities are conducted under Quality Assurance rules according to SR EN ISO 9001:2008 international standards for Clinical Trials.
Independent Ethics Committee
If request by the Sponsor, an Independent Ethics Committee can be involved to evaluate a clinical protocol. It is organized as an independent body constituted of medical/scientific professional and non-medical /non-scientific personnel. It’s responsibilities are:
- To safeguard the rights, safety and well-being of all trial subjects.
- To obtain and review required documents, should assess Investigators’ qualifications to conduct clinical trials.
- To present its approval/favorable opinion or disapproval/negative opinion in order for the trial to be conducted
- To conduct continuing review of each ongoing trial