Akkuratova str., 2, outpatient department, room 327
Phone/fax number +7 812 702 37 42
Clinical trials Department was founded at Almazov Federal Heart, Blood and Endocrinology Centre (today Federal Almazov North-West Medical Research Centre) in 2006. It was aimed at organization, coordination and general guidance of clinical trials. Tasks of the Department also included development of regulatory framework for the clinical trials in Federal Almazov North-West Medical Research Centre, GCP training of the personnel, cooperation with regulatory authorities, sponsors, CROs and Ethic Committee. One of the main tasks was the development of the general systems approach to preclinical and clinical trials in the Centre. In 2010 Clinical trials Department was transformed into research subdivision — Research Department of Clinical trials and Evidence-based Medicine. It was caused by the fact that the organization of clinical trials is only a part, albeit very signifycant, of the work of the Department.
Main activities of the Department include:
- Organizational support of clinical trial (drugs and medical technologies);
- Cooperation with regulatory authorities and clients;
- Reconciliation and issuance of documents;
- Coordination of activity of different departments and subdivisions of the Centre in the course of clinical trial;
- Coordination and support of the departments performing local trials;
- Accumulation and analysis of the information concerning clinical trials;
- Organization of CME course “Clinical Trials: the ABC” (in cooperation with CME Department);
- Organization of the clinical trials archive;
- Information support of the clinical trials.