Clinical expertise

Favorable conditions have been formed in Russia for clinical trials conduct. Large population, developed and well-structured medical system, highly qualified staff and increasing number of research centers with accreditation – all components that enable quick patient recruitment.

Introduction of GCP into industry standard, existence of ethical & drug control committees, and formation of independent audit system in Russia guarantee high quality of gathered data. Continuous presence of international pharma companies in Russian market contributes to growth of clinical trials number in Russia as well as geographical expansion of clinical trial sites.

GCP standard (“Good Clinical Practice”) - international ethic and scientific quality standard for development, conduct, and publication of trials results with people involved. Abidance by this standard assures observance of trials objects’ rights and safety, as well as reliability and accuracy of results

Furthermore, number of clinical trials conducted by domestic pharma and biotech companies is also growing. This trend is a response to latest federal programs supporting pharmaceutical and biotech innovations and industry development.

 Bonasana’s CT Department offers Russian and foreign pharma and biotech companies, quality and cost effective client-oriented services of clinical trials in Russia. A team of highly qualified and experienced specialists working in full compliance with GCP standards will manage approval of documentation for clinical trials in Roszdravnadzor (Russian FDA), audits of research centers involved in clinical trials, statistical processing of data, monitoring of late stages. Bonasana offers extended services of clinical trials including Phase I and bioequivalence studies. Our priority therapeutic areas for clinical trials include a wide range of infectious pathologies (respiratory diseases and tuberculosis), immune response disorders of different origin, ophthalmology, oncology, and dermatology. A range of services will be broadened after completion of construction of preclinical facility in Moscow region that will have FDA accreditation. The facility will also offer services of a pharmacokinetic laboratory for the Phase I of clinical trials.