Dostoevskaia, Zvenigorodskaia, Vladimirskaia, Dostoevskogo, h. 40-44
Ladozhskaia, Zanevskii av., 65, corp. 5
Zvezdnaia, Moskovskaia, av. Yuiri.Gagarina h.65,
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Research and Development Department

Специалисты

Фарапонова Мария Валерьевна
преподаватель, заместитель управляющего по научной работе, врач-хирург
учебная часть, администрация, поликлиника "звёздная"
Лидирующие позиции по клиническим исследованиям в Северо-Западном регионе
56 постоянных <br>спонсоров
56 постоянных
спонсоров
ТОП-5 исследовательских центров в РФ, рейтинг Synergy 2016-2019
ТОП-5 исследовательских центров в РФ
ТОП-5 исследовательских центров в РФ
Работаем в строгом соответствии со стандартами GCP (Надлежащая Клиническая Практика)
Стандарты ICH GCP
Стандарты ICH GCP
Проводим амбулаторный прием по всем клиническим направлениям
24 клинических направления
24 клинических направления

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.
  • Hide the text
  • 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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