Global Standard Compliant Trials
OCT works in compliance with international standards (ICH GCP), local regulatory requirements, and SOPs developed and regularly updated by our experienced Quality Assurance department.
OCT’s extensive experience in Europe and CIS countries helps to ensure fast enrollment of patients with different indications.
Successful expertise with FDA/EMA
The OCT team has successfully passed audits conducted by the EMA without any significant findings. The data, which was obtained as the result of research had been submitted to the FDA and the EMA for registration of drug products.
Quality Assurance department
We have passed more than 60 audits without findings of any significant violations. Our QA department is responsible for internal and external audits, study-related system audits as well as audits conducted by vendors and study sites that we work with.
OCT applied for regulatory approval in Russia and Bulgaria for a phase II study in patients after knee replacement
OCT team has started the application process to obtain the approval for a phase II study to investigate the antithrombotic effect in patients after knee replacement.read
OCT delegation at the Russian Pharmaceutical Forum
As a part of annual Adam Smith Conference program 2019, the Russian Pharmaceutical Forum took place on May 14-15 in Moscow. The annual event gathers key industry players from Russia and the CIS region.read
Capitalizing on the local expertise on the global clinical research market as a success strategy
OCT Clinical Trials, a leading CRO on the Eastern European market, increases its share of overseas partnerships. By the end of 2018, the company’s portfolio included over 2017 projects, with 31 started in 2018, a half of which were phase III studies.read
BIO KOREA 2019: global trends in biotechnology and clinical research
OCT delegation has successfully completed their business trip to attend BIO KOREA conference that took place in Seoul on April, 17-19. One of the world's leading biotechnology events, BIO KOREA provides opportunities to domestic and overseas companies for extended cooperation in biopharma business and clinical research.read