Clinical Trials


OCT team provides a full range of high-quality services within Phase I to IV and BE studies organization and conduct. We are engaged in the project at every stage – from clinical strategy and study design preparation to data management and biostatistics.


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.


One of the most experienced teams on the market


Our experienced team consists of over 200 professionals. The vast majority of our clinical department workers are highly qualified specialists with degrees in the fields of medicine, pharmaceutics and natural sciences. The average experience of our employees in clinical trials is more than 5 years.


Support


OCT team is always easy to reach: OCT provides initial trial strategy and design consulting, regulatory support, permanent information about clinical trial progress.

Clinical trial phases
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Early-stage clinical studies: Phase I / IIa

OCT has extensive experience in conducting first-in-human clinical trials in Russia, Central and Eastern Europe both in healthy volunteers and patients (depending on the requirements of study design or ethical/regulatory authorities).

In the countries of our operation OCT cooperates with the leading early stage research centers, in order to assure fast enrollment of subjects. We take a strategic approach to the site selection process for early-stage studies, trying to optimize expenses that are associated with bio-sample logistics.


Pivotal clinical trials: Phase II/III

When choosing a region for conducting pivotal clinical trials, sponsors often turn to countries in Central and Eastern Europe (CEE). This region is not only appealing in terms of access to a large number of patients, but also provides access to a vast market.

Our in-depth experience with more than 270 projects in a great number of therapeutic areas and established relationships with key opinion leaders and principal investigators in more than 1600 medical sites gives us absolute confidence both in the quality of data derived from the clinical trials we conduct as well as in our ability to meet demanding recruitment timelines.


Post-authorization / Post-marketing / Phase IV Studies

OCT has conducted more than 25 post-authorization clinical trials. Central and Eastern Europe is one of the key regions involved in such trials. Post-approval studies are divided into two groups: clinical (interventional) trials and pharmacoepidemiology (non-interventional/ observational) studies.


Interventional studies

In interventional studies (always prospective), a drug is used in accordance with the registered indication, however the examination and treatment scheme is determined by the study protocol and can differ from standard practice.


Non-interventional studies

In non-interventional studies, patients receive a drug, device or procedure as a routine treatment, in accordance with Summary of Product Characteristics and without any special procedures, i.e. without prescribing treatments or tests. Upon obtaining the new data, observational studies may lead to the planning and initiation of additional clinical trials with the purpose of new data registration.