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The AX CT company provides all necessary services within the framework of organizing and conducting clinical trials. Services are provided both on a turnkey basis and for individual types of services.
We offer comprehensive, qualified support during clinical trials to achieve a single goal: ensuring that drugs are brought to market as quickly and cost-effectively as possible.
We interact with clinical centers that have successfully passed inspections by Roszdravnadzor and audits of international pharmaceutical companies, which allows us to conduct high-quality research and obtain objective results.
We offer full support from the moment of planning a study to obtaining a registration certificate for introducing a generic drug to the markets of Russia and the EAEU countries.
Our team has 10 years of experience in managing these projects from the moment of research planning and strategy selection to the formation of the final report and transition to the next phase. We interact with clinical centers that have successfully passed inspections and audits of Roszdravnadzor and international pharmaceutical companies.
Phase II studies are one of the main stages among pre-registration studies, as they allow one to prove one of the most important properties of any medical product - its effectiveness on target groups of patients.
We have all the necessary resources to conduct labor-intensive phase II studies and organize them from the stage of writing the protocol to the full assessment of the results obtained, followed by the formation of recommendations for preparation for further studies.
The company has extensive connections with clinical centers located throughout the Russian Federation, EAEU and CIS countries, and resources for organizing and conducting high-quality late-phase studies, including international ones, on all existing nosologies in a short time and with an optimal budget.
The presence of experienced project managers and monitors on staff, as well as the use of validated electronic data collection and processing systems, allows us to quickly and efficiently conduct research of any complexity in accordance with legal regulations.
Post-marketing (post-registration) studies play an important role in further studying the safety and effectiveness of medical products, allowing us to obtain significant information in order to optimize their use, as well as to prevent withdrawal or restriction of sales.
Assistance in organizing studies of this phase will be especially useful for manufacturers of drugs that have been on the market for a long time, to prove the rationality of their use, and therefore confirm the clinical validity of the use of drugs, which is the key to further successful circulation in the pharmaceutical market.
You can provide only the molecule name, and we will develop the entire strategy for bringing the drug to market: from designing, calculating the sample size, selecting a reference drug, its procurement (in the Russian Federation or import), to writing the final report on the conducted research and submitting it to regulatory authorities.
Fill out the feedback form and we will provide you with a set of documents, which includes: