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Quality Assurance and Quality Control

"Quality is Reputation" - such is the fundamental principle underlying all the activities of our Company. Our quality control unit promises our clients that all services are provided in accordance with international requirements and standards applicable to clinical investigations. The employees of Congenix make wide use in their work of the standard operating procedures, or SOPs, developed together with foreign consulting companies specializing in the quality management of clinical tials. SOPs are a manual of practical guidelines, containing answers to any questions which might arise in the course of daily professional work. Our employees are subject to obligatory training in SOPs both of our own Company and those of the client, if any are provided. Quality assurance and quality control activities consist in:

  • development of a quality assurance plan to be used as a framework for practical measures designated to ensure step-by-step control over the quality of work under each project;
  • identification of the person-in-charge under whose responsibility the project will be implemented;
  • preliminary review of the protocol and other study documents in terms of mutual consistency in order to exclude any possible discrepancies and itemize all procedures to the maximum extent possible, which will considerably lessen the risk of inaccurate data being received by the client;
  • review of additions/amendments to the study files from the point of view of particularities of each project;
  • control and audit of the process of identification and selection of study sites;
  • control and audit of the monitoring plan;
  • control and audit of the study documentation;
  • control over regular study specific training sessions for the Company personnel involved into the project;
  • control over training sessions for the investigators involved into the project;
  • control and audit of the project reports;
  • control and audit of the computer systems, used in each particular project;
  • audit of the sites through which the study is carried out;
  • organization and holding of training sessions for Company personnel.

Clinical trials, as a part of the drug development process, form a dynamically developing sector. For this reason, the basic principle adhered to in the course of preparing training programs is not so much to provide training for the whole duration of activities but to develop a training program to be implemented throughout the whole course of activities, i.e. in progress. Training sessions may be devoted to the fundamental principles of clinical trials or provide the latest information on clinical investigations. Training programs are designed to develop corporate and attractive staff, and to enhance employees' motivation to perform their work with the highest degree of responsibility and quality.

Clinical monitoring

Project management

Regulatory Affairs