The training manual «Clinical project management»

Abstract

The training manual «Clinical project management» describes a methodology for the effective management of a clinical project for finding, developing and marketing pharmaceuticals products, starting with the search for new chemical compounds, preclinical testing of candidate substances, clinical trials of candidate in drugs, pharmacovigilance, data management, analysis of the data, drafting the final study report, obtaining registration certificate, quality assurance of trials, publication the results, ending with the organization of post-authorization safety studies, conducting non-interventional and pharmacoepidemiological studies, audit and inspection of regulatory authorities, creating standard operating procedures and archiving research documents. The material is based on modern Russian Federation and Eurasian Economic Union regulations. The manual is addressed to those who are directly involved in the development of new drugs: clinical project managers, clinical research associates, specialist in pharmacovigilance, data management, statistical analysis, quality assurance and control, registration, representatives of regulatory and medical departments, medical writers, working in innovative pharmaceutical companies and contract research organizations. Presented materials will also be useful to investigators, employees in research institutes and organizations involved in the search of new molecular entities, preclinical and clinical trials, and to the health authorities, that regulate their conduct.

Keywords

• клинические исследования
• управление клиническими исследованиями
• клинический проектный менеджмент
• специалист по клиническим исследованиям
• клинический проектный менеджер
• учебное пособие
• clinical trials
• clinical project management
• conducting clinical trials
• clinical project manager
• clinical research associate
• training manual