Development of medical documentation

Specialists of AX CT LLC, who have experience in scientific, medical fields and in the field of biostatistics, develop medical documentation and prepare a complete package of documents for clinical trials.

Documents prepared by us comply with all applicable principles of Good Clinical Practice (GCP) adopted at the International Conference on Harmonization (ICH), as well as regulatory requirements of government authorities.

Medical writers of AX CT LLC have extensive experience in designing studies for various types of medicinal products for medical use, including generics and biosimilars.

"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