At OCT we provide a full spectrum of services required for the organization and conduct of Phase I to IV clinical trials.
We act as a single point of contact for Sponsors requiring delivery of turn-key projects. OCT’s services include initial consulting on clinical trial strategy and study design, the writing, reviewing and translating study documents, and the provision of regulatory support in preparing and submitting the package of documents required to obtain study approval. OCT are also able to prepare your Registration Dossier to obtain marketing authorization of medicinal products in Russia.
Throughout the study, the OCT Project Manager is your main point contact, providing daily, weekly and monthly updates to keep core team members current on all project activities.
OCT provides logistics support in obtaining all required import licenses, distributing drug and study supplies to sites, and in obtaining an export license for shipment of biosamples where needed.
OCT works in compliance with international standards (ICH GCP), local regulatory requirements, and SOPs developed and regularly updated by our experienced Quality Assurance department. Our QA department is also responsible for internal and external audits, study-related system audits and audits of vendors and study sites that we work with.
All safety management tasks are performed by OCT’s Pharmacovigilance team, including collection of SAEs. Our team handles both paper and electronic forms through our in-house, fully validated
MATRIX is used in all phases of both paper and web-based clinical research studies, increasing data accuracy while decreasing the time required for data collection
OCT has solid experience in conducting first in man clinical trials in Russia and Central and Eastern Europe both in healthy volunteers and patients (if required by the study design or ethical/regulatory authorities).
OCT works with leading phase I units to rapidly enroll both healthy volunteers and patients in the countries in which we operate. OCT places its early stage clinical trials at strategically chosen locations to achieve accelerated and targeted patient access - whilst also taking into consideration the customer’s drug development and marketing goals.
Central and Eastern Europe (CEE) is a well recognized region for conducting pivotal clinical trials. The countries in this region provide access to a vast market as well as to diverse patient populations. Study timelines are reduced as a result of faster enrollment in the majority of therapeutic areas offering the potential for significant efficiencies and cost savings.
With offices in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria, as well as the US, OCT covers a significant patient population. Our locations in Russia and CEE, with large populations and high levels of disease prevalence, often drug-naive in several therapeutic areas, gives us an incontestable advantage.
Our in-depth experience within more than 250 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 and our ability to meet demanding recruitment timelines.
OCT has conducted more than 25 post-authorization clinical trials. Post-Approval or Post-marketing Trials or Phase IV studies are the fastest growing area of research today and Russia. 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. OCT has experience in both types of trials.
In interventional studies (always prospective), patients are systemically allocated to specific treatment, which may not be what they would have received normally, or investigations or procedures may be carried-out which are not part of routine practice.
In non-interventional studies, patients receive a medicine or device or procedure as routine treatment, in accordance with Summary of Product Characteristics and without any special procedures, i.e. without prescribing treatments or tests. Non-interventional studies or observational studies can provide invaluable data on the safety and effectiveness of a product and/or information about the natural history of a disease under standard care practices. On obtaining the new data, observational studies may lead to the planning and initiation of additional clinical trials.
In a descriptive observational study, diseases are characterized according to where, when and to whom they occur. Analytic observational study (mostly called registries) involves testing hypotheses about exposure-disease relationships and quantifying the levels of risk such exposures may entail.
Descriptive studies examine differences in disease rates among populations in relation to age, gender, race, and differences in temporal or environmental conditions. Registries serve many purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care.
At OCT we understand the specificity of post-approval studies and do our best to fit the programs strategy and design. OCT has a broad database of sites to be used in Phase IV trials requiring larger populations over broader timeframes.
In Russia, post-approval clinical trials are called post-registration clinical trials and regulated by the federal law "On Circulation of Medicines" 61-FZ dated 12-Apr-2010 and other implemented requirements for clinical trials conduct (GCP, etc.). According to the law, post-registration clinical trial of a medicinal product for medical use is a clinical trial of a medicinal product for medical use conducted by the manufacturer of the medicinal product, which is put in civil circulation after the state registration, for the purpose of additional collection of data on its safety and efficacy, extension of indications of such medicinal product, as well as for the purpose of revealing adverse reactions of the medicinal product on the patients; post-registration clinical trial of a medicinal product for medical use shall be carried-out under a permit to conduct a clinical trial of the medicinal product issued by the authorized federal executive body upon the results of the expert examination of the documents required for obtaining a permit to conduct an international multi-centre clinical trial of the medicinal product or post-registration clinical trial of the medicinal product and ethical expert examination.