Research and Development Department

R&D Department is created to plan, maintain and coordinate the R&D Center activity, to enhance and implement new methods of activity management, including works based on the current-day information technologies.

ACTIVITIES

• Regulatory, informational and consulting support and support for R&D works and scientific activity of R&D Center divisions.
• Surveying the needs and identifying of priorities for researches and editorial and publishing activity, implementation of such activity planning.
• Development of promising projects and research schedules.
• Management of activities aimed at implementing scientific research results into practice, generalization and analysis of the efficiency factor for scientific development application within the R&D Center activity where they are intended to be applied.
• Development and management of scientific researches, events and conferences.
• Providing support to business units and certain specialists regarding the management and research methodology when planning and holding researches and scientific events.
• Rendering assistance to the business unit personnel to prepare publication materials, including those to be published in peer-reviewed journals.
• Publication library management for the personnel and the Company business segment.
• Review of clinical trial databases for medicinal drugs.
• Participation in SOP development/updating.
• Quality Control DEPARTMENT for clinical trial of medicinal products
• QC Department is created to manage, control and improve the quality of the medicinal drug clinical studies at the R&D Center.
• Management and control of standard operating procedures (SOP) communication at the R&D Center
• SOP updating and revision procedure management;
• Provision of guidance to R&D Center personnel on SOP development;
• Verification of new and updated SOPs;
• Management of SOP introduction procedure to R&D Center personnel;
• Control of compliance of R&D Center personnel with the requirements set forth in the SOP;
• Arrangement of SOP hard copy storage;
• Archiving of outdated SOPs;
• Arrangement and participation in internal trainings for the R&D Center personnel;
• Consulting on new and updated SOPs;
• Training for the research team members as part of the applicable protocol, holding briefings;
• Training for the research team members relating to problems identified during the internal audit;
• Arrangement and participation in the scheduled training on Good Clinical Practice for the R&D Center personnel;
• Training material development and preparation;
• Quality control of medical records relating to medicinal drug clinical trials
• Participation in audits by sponsors and monitors of contractual research organizations;
• Actions to eliminate the discrepancies found on the audits, monitoring visits;
• Scheduled control of records management as part of the medicinal drug clinical trials;
• Ensuring well-timed medical record completion during the medicinal drug clinical trials;
• Internal audit as part of monitoring visit arrangements;
• Filing of references when arranging to monitoring visits based on the internal audit results;
• Holding consulting sessions on defect elimination identified during the internal audit related to primary documentation management;
• Development of reports by the internal audit findings;
• internal audit program development.
•  Participation in the research work planning and execution;
• Participation in report development on clinical trial results for medicinal drugs;
• Review of databases on the medicinal drug clinical trials, data analysis;
• Writing articles, publication management in the field of medicinal drug clinical trials;
• Monitoring of scientific papers associated with medicinal drug clinical trials and quality of procedure thereof.
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• UNIT for R&D Program Institutional Support and Guidance
• The UNIT for R&D Program Institutional Support and Guidance is created to deliver organizational and methodological support to the diagnostic and treatment process, research activity and clinical studies of medicinal drugs at the R&D Center premises

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