Clinical Trials and Evidence-Based Medicine

 
Address of the department:
2 Akkuratova street,
20th floor, room 1.20.26
Phone/fax number +7 812 702 37 42
Е-mail: cr@almazovcentre.ru

The Department for Clinical Trials and Evidence-Based Medicine was established at the Almazov Centre in 2006 to organize, coordinate, guide and oversee the conduct of clinical trials. The tasks of the Department include developing the regulatory framework for the conduct of trials at the Centre, organizing the GCP trainings for the clinical trial staff, cooperating with regulatory authorities, sponsors, and Ethics Committee as well as developing the system for preclinical and clinical trials at the Centre in general.

In 2010, the Clinical Trials Department was transformed into a research unit because the organization of drug trials is only a part, albeit an important one, of the work carried out by the department.

Main activities of the department:

  • Providing organizational support for clinical trials (drugs, medical products and devices)
  • Cooperating with regulatory authorities and sponsors
  • Negotiating and executing agreements and other relevant study-related documents
  • Coordinating the activities of different departments on the matters related to the international multicenter clinical trials
  • Coordinating and providing technical support to the departments carrying out local trials
  • Compiling and analyzing the information related to the conduct of clinical trials
  • Organizing, preparing and delivering the advanced training course The Basics of Clinical Trials (together with the postgraduate training department)
  • Arranging the record-keeping of clinical trials
  • Providing informational support for the trials

Given the expanding range of services and opening of the new unit for early-phase clinical trials, the clinical research association, the Clinical Trials Center, was established in 2014. In addition to the conduct of clinical and preclinical trials, bioequivalence studies, we provide a full range of services for scientific support of projects, from study design to clinical study report, as well as expert review and medical translations.