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Clinical monitoring

A service's uniqueness depends on a combination of two essential factors. We believe that our services are unique because, firstly, our clinical monitoring team consists of university-educated doctors specializing in several branches of medicine and secondly, the advanced educational program and training courses offered by the Company to its employees ensure professional adequacy required for clinical studies and the highest quality of services, which include, but are not limited to:

  • provisional feasibility assessment of study sites which are planned to form part of study in order to provide the client with objective information on the possibilities for enrolling patients in consistency with the project's goals and objectives;
  • visiting the study sites for qualifying purposes, involving assessment of human and technical resources in terms of their consistency with protocol requirements;
  • preparation of document packages which need to be submitted to local and international regulatory authorities;
  • preparation of study document packages for ethical expert examination;
  • training study site personnel involved in the project;
  • site initiation visit performance;
  • regular monitoring visits in order to ensure strict compliance of all trial procedures with protocol requirements, ICH GCP, as well as the requirements of international and local regulatory authorities;
  • control over the process of handling investigational product and study materials;
  • timely and regular updating of the investigator's file;
  • quality supervision of the process of source documentation maintenance and correct filling-in of patient's case report forms;
  • control over timely reporting on serious adverse events in accordance with the protocol requirements;
  • detailed reporting on the work performed;
  • resolution of current problems arising in the course of project implementation;
  • control over the quality and terms adhered to by the investigators in dealing with the questions that the data management group may have in the course of data processing (query resolution);
  • site closure visits performance and archiving of study documents.

The clinical monitoring team can meet the highest requirements of our clients due to its in-depth knowledge of medicine, advanced theoretical and practical background, interest in the efficient performance of clients' assignments, and thorough understanding of the nature of the clinical trial process.

Project management

Regulatory Affairs

Quality Assurance and Quality Control