Site Management Organizations in Non-Clinical Studies
Опубликовано в Биоэкономика и экобиополитика №1 (1) декабрь 2015 г.
Дата публикации: 15.01.2016
Статья просмотрена: 2 раза
Рыбкина Е. П., Чистяков И. Н. Site Management Organizations in Non-Clinical Studies // Биоэкономика и экобиополитика. 2015. №1.
Biopharmaceuticals industry imperatives demands a systematic approach to preclinical research that starts with predefined objectives and emphasizes processes, systems, and process control based on quality risk management. Centralized management of business and operational functions intended to control the quality and performance of work from the very beginning of the planning phase, usage entire quality metrics relating to preclinical research safety, risk, and conduct standards, generalized for the group of Investigational Sites allows to maintain required level of quality of study results, reduces data bias, monitoring and management burdens while facilitating trial supply and documentation. The survey is aimed to provide a summary of the modern market situation, SMO definitions and Preclinical Study Centre roles and responsibilities within the Pushchino Scientific Center and the biotechnological regional innovation cluster network.