Risk Management in Preclinical Trials as Part of an Overall Integrated Quality Management System

The implementation of a complex risk-oriented approach at all stages of drug development, including the preclinical research stage, is essential for ensuring drug safety, quality and effi cacy. The aim of the study was to justify the benefits of introducing risk management into the integrated quality management system at the preclinical trial stage. The optimal approach to implementing risk management system at the preclinical stage is an overall process approach based on the international standard ISO 31000:2009 Risk management—Principles and guidelines. This approach as applied to a preclinical research centre includes a three-tier risk management system at the level of operational process subsystems, the level of the testing centre’s departments, and the level of an individual preclinical study. The common components of the subsystems may include concepts, organisational structure, information exchange system, documentation structure, etc. The process of risk management as applied to the subsystems includes risk identification, analysis, assessment, and response to the risk. The response to the risk is an iterative process that includes selection of response options, response planning, and implementation of response activities from control procedures to corrective and preventive actions. The integration of the preclinical risk management system into the organisation’s overall management system, which includes the occupational health and safety management system and the quality management system, will enhance the capabilities of the individual systems to achieve a high quality level of research, preserve the staff ’s professional health, make informed management decisions within the organisation, increase preparedness for external audits, and gain competitive advantages.

preclinical trials, good laboratory practice, risk management, quality management system, safety management system, regulatory documentation

1. Azembaev AA, Yussufi SD, Uteev RA. Analysis of GMP, GLP, GCR, ISO. Zdravookhranenie Tadzhikistana = Health Care of Tajikistan. 2016;(1):85–9 (In Russ.)

2. Zueva OV, Zhirnova EA. Risk management as part of an integrated management system in accordance with GOST ISO 31000-2010. Aktual’nye problemy aviatsii i kosmonavtiki = Actual Problems of Aviation and Astronautics. 2014;1(10):264–5 (In Russ.)

3. Solod VS, Shabalin GA, Novikov VV, Shabalina SG, Sklemenov GZh. Analysis of requirements for implementation of the process approach in the systems of safety management. Sovremennye naukoemkie tekhnologii = Modern High Technologies. 2017;(6):88–92 (In Russ.)

4. Atapina NV, Kononov VN. Comparative analysis of risk assessment methods and approaches to risk management organization. Molodoy uchenyy = Young Scientist. 2013;2(5):235–42 (In Russ.)

5. Manuilov DM. Implementation of efficient quality management systems in organizations engaged in preclinical and clinical trials and pharmacovigilance. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):126–32 (In Russ.)

6. Okolnishnikova IYu, Katochkov EV. The conceptual foundations of formation and development of the system of company risk-management. Vestnik Yuzhno-Ural’skogo gosudarstvennogo universiteta. Seriya: Ekonomika i menedzhment = Bulletin of the South Ural State University. Series: Economics and Management. 2013;7(2):131–6 (In Russ.)

7. Zaytseva MA, Ivanov MB, Pikalova LV, Kashina TV. Quality purposes and policy at preclinical testing conducting. Fundamental’nye issledovaniya = Fundamental Research. 2013;(9):239–42 (In Russ.)

8. Serebryakova TYu. Enterprise risk management: a methodological aspect. Bukhgalterskiy uchet v byudzhetnykh i nekommercheskikh organizatsiyakh = Accounting in Budgetary and Non-Profit Organizations. 2017;(22):17–30 (In Russ.)

9. Burova ED, Khodko SV, Gushchin a SV, Makarova MN, Makarov VG. Risk management for quality assurance of preclinical research. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(1):25–32 (In Russ.)

10.