ACTO was duly established at the end of November 2007 as non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia. The situation involving the export of biological samples, which occurred in May 2007, was the stimulus that led companies to create the Association. At that time there was a lack of uniting power, to appeal on behalf of business.
The primary objectives of the Association are to further develop Russia as clinical research country/market, to ensure a proper and effective balance between the interests of parties involved in clinical trials including the patients, the medical community, and the governmental agencies, to harmonize local legislative basis for the clinical trials with the respective worldwide standards, and to promote an ethical business model.
Each ACTO’s member conducts clinical trials in accordance with international standard of Good Clinical Practice (ICH GCP). In accordance with the Statutes of Association ACTO’s members should follow the principles of integrity, respect for other market participants, and not admit cases of unfair competition.
AСTO performs its activities through three committees set up on the most important areas:
Promotion of the optimization of regulatory authorities work (Regulatory committee);
Analysis and development of solutions to logistical problems encountered in conducting clinical trials (Committee on logistics);
Analysis of market initiatives to change legislation and developmentof Association proposals to improve the legal framework (Legislative committee).
To address urgent challenges ACTO creates working groups.
The Association invites organizations, associations and institutes engaged in clinical trials activities in Russia for partnering.