Consulting and regulatory support

Specialists of AX CT LLC provide a wide range of consulting services in the organization and support of preclinical and clinical trials, pharmacovigilance and safety in research, drug registration, biostatistics and data management, development and preparation of medical documentation. Also, AX CT LLC provides regulatory support – this is a complex process that ensures that the parameters of the clinical development of the product comply with its main goal – obtaining a registration certificate.

Our experts can assist in design development, selection of randomization methods, selection of study endpoints, determination of the required number of patients/volunteers to obtain a statistically significant conclusion, directly during the analysis of the results obtained, the formation of a conclusion and the preparation of the final report on the results of clinical trials.

"Turnkey" Project

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.

Optimal speed and quality of services

Full compliance with international norms and standards

Logistical availability

Risk reduction and rapid response