accordance with Russian Federation legislation in most cases local set of
preclinical studies should be conducted on the territory of RF before commence
of clinical part of research.
NADIM CRO provides full cycle service in preclinical studies, also we are ready to organize separate steps of preclinical program, e.g.:
• selection of the laboratory for preclinical research;
• preparation of preclinical plan and protocol of preclinical study, consultation with leading experts in preclinical toxicology for development of testing program and appropriate experimental models, thus avoiding unnecessary financial costs and loss of time;
• organization of the experiment in acute, sub-acute and long-term toxicity, pharmacological activity of the drug and metabolites, kinetics of absorption, metabolism, distribution and elimination of a substance in rodent and non-rodent models were necessary, also we provide statistical analysis of data;
• arrange sponsors audit of the laboratory before start of preclinical testing .
It is very important to choose appropriate laboratory, but in order to be on the safe side we arrange consulting of the results at the regulatory bodies before submission.
NADIM CRO works closely with leading
research centers, has a great experience in preclinical testing of generic
medicines and biosimilars. We offer you an honest business, successful
execution of the work for the shortest time and the best prices.
- Pharmacoeconomic studies
- Development of medical documentation
- Medical statistics and translations