We offer you the organization and support of preclinical studies for the registration of generics and innovative drugs (study of general and special toxicity of drugs, immunogenicity, special activity, carcinogenicity and other characteristics of drugs) on the basis of a vivarium that meets all modern standards and requirements for maintenance and operation with laboratory animals.
Animal studies are carried out by highly qualified personnel with extensive experience in accordance with approved SOPs and standards.
It is possible to conduct research according to the customer's specifications and develop a study design with modeling of pathological conditions of animals.
Organization and support of clinical trials is a process that includes planning, conducting, monitoring and analyzing the results of clinical trials of new medical products, procedures and technologies.
The organization of clinical trials includes definition of study objectives, development of the study protocol, selection and randomization of patients, organization of training and monitoring of the study, and preparation of documents for regulatory authorities.
Support for clinical trials includes monitoring compliance with the trial protocol, monitoring the safety and efficacy of medical products, processing and analyzing the data obtained, preparing reports and publications.
The organization and support of clinical trials are carried out in accordance with international standards and recommendations, such as the Helsinki Declaration, the International Council for the Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use, and others.
Organizations engaged in the organization and maintenance of clinical trials must have the appropriate license and certification, as well as experience and qualifications in this area.
To conduct clinical trials on the territory of the EAEU countries, it is necessary to obtain permission to conduct a study from the relevant state bodies. At the same time, the study should be conducted in accordance with international standards and principles, as well as considering national rules and regulatory requirements.
Companies wishing to conduct clinical trials in the territory of the EAEU countries must submit relevant documents, including the study protocol, monitoring plan, patient consent, etc. After obtaining permission to conduct a study, the company must comply with the principles and rules established in the permit.
In general, clinical trials in the EAEU countries are conducted in accordance with international standards and principles, which makes it possible to guarantee the safety and efficacy of medical products.