The OCT team performs all the necessary tasks within the framework of organizing and conducting Phase I–IV clinical trials and BE studies. We fully take care of each stage of the project, from trial design to market authorization and can provide full services as well as standalone activities for your trial.
The needs of clients are our top priority. Therefore, the clinical team does its best to provide you with tailored solutions for each project.
The OCT team is as flexible as possible in communication and is always in touch: clients receive answers to any requests (initial consultation on research strategy and design, regulatory support, informing the project team about the progress of the study) within 24 hours.
The key to the success of any project is being able to stay on track with everything. The vast experience of our employees allows us to deliver all projects on time and within the established budget.
OCT has extensive experience in conducting Phase I clinical trials of first-in-human drugs in Russia and EAEU countries, with the participation of both healthy volunteers and patients (depending on the requirements of the study design or Ethical Committees/Regulatory Authorities).
In the countries where we operate, we cooperate with leading Phase I research centers to ensure rapid site activation. Such a strategic approach to the selection of a site for early-phase clinical trials provides patients with quick and targeted access to investigational drugs, with due regard also given to the goals of the client’s drugs, both when under development and during the process of obtaining marketing authorization.
When it comes to choosing a location for conducting pivotal clinical trials, Russia and EAEU countries are in high demand. This region provides access to a large participation pool while also offering a wide range of patient populations. Lower costs for enrolling patients in most therapeutic areas mean a reduction in the duration of research, thereby allowing for budget optimization.
OCT successfully conducts clinical trials on the territory of Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan, demonstrating that the company has a significant geographical coverage of patient populations. An undeniable advantage in these regions is the presence of a high population and elevated disease prevalence in several therapeutic areas, with many patients often untreated.
We have extensive experience, having conducted more than 300 clinical trials in various therapeutic areas and established connections with key leading specialists and principal investigators in more than 1,600 research sites. Therefore, partners can have absolute confidence both in the quality of data obtained as part of the company's clinical trials and in our ability to meet strict deadlines for patient recruitment.
OCT has successfully conducted more than 25 post-marketing studies. To date, the fastest growing area of clinical research in Russia is post-registration and post-marketing trials or Phase IV trials.
There are two types of post-marketing studies: clinical (interventional) studies and pharmacoepidemiologic (non-interventional/observational) studies. Our company has experience in conducting both types of studies, which is of particular importance to many Sponsors.
