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.
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Archiving of outdated SOPs;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