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Project management

The success of any project depends on the management's ability to maintain a certain balance between the implementation and quality of work performance, as well as on its ability to observe terms set forth by the client for implementation of the project. Our project management team is effective in addressing all these complex tasks. Each member has at least 5 years' experience in the clinical trial business. Project Management consists of the following stages:

Planning and preparative stage of a project

  • planning resources required for high-quality and timely realization of the project, and setting up a team;
  • planning the optimal number of study sites with due regard to the client's requirements as to the number of patients and promptness of their enrollment;
  • planning and developing budget estimates for the project;
  • preparing contracts with study centres;
  • preparing and conducting training for the project team in order to inform the latter on all the procedures and documents related to the study;
  • developing a monitoring plan;
  • obtaining approvals from permitting authorities for conducting trials on the territory of the Russian Federation, Ukraine and Baltic countries, making arrangements for the entry of the investigational product and study materials (study supplies), as well as for the exit of biological samples inside and outside of the customs territory;
  • organizing the investigator's meeting;

Control over the course of the project implementation

  • supervision over compliance with the terms and volumes of works on all project stages according to the client's requirements;
  • control over, and effective management of the study budget;
  • grant negotiation and administration;
  • quality control through co-monitoring inspection visits;
  • supervision over timely ethical expert examination of the study documents;
  • resolution of problematic situations arising in the course of the project;
  • ongoing communication with the client's representatives;
  • holding conference calls with the participation of project team members and client's representatives;
  • holding progress meetings in the course of the project;
  • preparing study status reports reflecting the course of the project;

Study completion

  • planning site closure visits;
  • coordination of interaction between the project team and the data management group;
  • coordination of processes providing for destruction of the investigational product;
  • planning of, and control over archiving of study materials.

The ability to see the wider picture, forecast and assess risks, and tackle problems that may arise in the course of project implementation are the main advantages of the Congenix's project management team.

Clinical monitoring

Regulatory Affairs

Quality Assurance and Quality Control