OCT offers a full range of clinical trial services for Phase I-IV and BE studies, including study design, regulatory support, site management and more.
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 collaborates with the leading early stage research centers, in order to assure fast enrollment of subjects.
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 many patients, but also provides access to a vast market.
Our in-depth experience with 300 projects in a great number of therapeutic areas and access to a network of principal investigators in more than 1600 medical sites give 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.
OCT has conducted more than 25 post-authorization clinical trials. Central and Eastern Europe is one of the key regions engaged in such trials. Post-approval studies are divided into two groups: clinical (interventional) trials and pharmacoepidemiology (non-interventional/ observational) 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.
In non-interventional studies, patients receive a drug, device or procedure as a routine treatment, in accordance with the 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 planning and initiation of additional clinical trials with the purpose of new data registration.
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