Full-Service Clinical Trials in Central and Eastern Europe

OCT has good experience in organization of preclinical studies. We offer a broad range of preclinical services in Russia:

• Safety Pharmacology
• Acute toxicity
• Specific toxicity
• Sub-chronic and chronic toxicity
• Allergenicity
• Reproduction toxicity and Carcinogenicity
• Mutagenicity Studies
• Immunotoxicology
• Efficacy Pharmacology
  • Central Nerve System
  • Cardiovascular System
  • Autoimmune diseases
  • Diabetes
  • Oncology

OCT is happy to provide services in bioequivalence trials conduct. OCT experts have experience in more than 50 bioequivalence studies. OCT has long-term collaboration with a phase I unit and analytical laboratories in Russia. The phase I unit we work with has a license for volunteers’ hospitalization. The site is one of the biggest sites in Russia. The capacity of the site is up to 40 beds. The analytical laboratories we work with have state-of-the-art equipment to provide a full range of bioanalytical services. They use the following techniques in bioanalytical studies:

• LC–MS (liquid chromatography–mass spectrometry)
• HPLC (high performance liquid chromatography)
• CE–MS (capillary electrophoresis–mass spectrometry)

On September 1, 2010 a new law came into force – law #61 as of April 12, 2010. According to the new legislation “On medicines circulation”, in Russia, generic medicinal products intended for medical use are subject to trials for bioequivalence and/or therapeutic equivalence in this country. OCT can assist generics companies to get their drugs registered in Russia. We provide a full package of services to bring your generics products to the Russian market.
We can perform pre-clinical studies of generic drugs, which are requested by the Russian Regulations. We perform pre-clinical studies at the leading pre-clinical sites in Russia.

OCT can prepare a full package of study documents necessary to perform bioequivalence studies:

• Study Protocol
• Case Report Forms (CRFs)
• Informed Consent Forms (ICF)
• Investigator’s Brochure (IB)

OCT will assist you with clinical study submission to the Regulatory Authorities in Russia.

Phase I unit we work with will be responsible for:

• Healthy volunteers recruitment
• Drug administration
• Laboratory tests
• Blood sampling
• Hopsitalization
• Catering
• Emergency care

OCT will perform routine monitoring visits to make sure that the study is performed in accordance with GCP and relevant guidelines.

 

Bioanalytical part will be performed at one of our partner laboratories:

• Samples collection
• Drug/metabolite assay development and validation
• Drug/metabolite analysis
• Data Analyses

OCT will perform Quality Assurance and Quality Check at every stage of the study. At the end of the study, our clients receive final report, which will enable them to get their drugs registered in Russia.

OCT has solid experience in conducting first in man clinical trials in Russia and CEE countries. OCT works with leading phase I units which can enroll healthy volunteers quickly into first in man studies in Russia and Europe.

OCT places its early stage clinical trials at strategically chosen locations for accelerated targeted patient access.
OCT provides a full spectrum of clinical trial services to our clients when performing early stage clinical trials:

• Clinical Monitoring
• Clinical Supply Management
• Consulting
• Data Management
• GCP trainings
• Insurance
• Interactive Web Response Systems (IWRS)
• Investigator Meeting
• Medical Writing
• Pharmacovigilance Services
• Project Management
• Quality Assurance Services
• Regulatory
• Statistics
• Study Feasibility

Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria are a great region for conducting pivotal clinical trials. This region provides access to a very large market and diverse patient populations, while significantly lowering the cost of conducting clinical research.

Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria cover a significant patient population of over 250 MM people. We believe that OCT geographical location is a strategic advantage. Having access to a large population which is drug-naive in several therapeutic areas, and has not been exposed to many new western drugs, and disease prevalence is similar to other European countries and is higher in some locations.. This translates into some key advantages for placing trials in these territories, including fast recruitment, and offering the potential for significant cost savings.

However, while it is well recognized that patient recruitment is important for a successful trial, also crucial is that trials are well-run and well-monitored. Having been in business for several years, OCT is experienced in a wide range of therapeutic areas. Moreover, we have a record of successful trial completion, and have all of the necessary qualifications and experience in ICH GCP, and other quality systems. Many of these completed trials have resulted in repeat business opportunities.

OCT can plan and manage your pivotal trials from the very beginning to the end.

Most of trials at OCT are phase IIb and III clinical studies.

OCT has solid experience in conducting post-authorization clinical trials executed after the product is approved for marketing. Post-Approval or Post-marketing Trials or Phase IV studies are the fastest growing area of research today and Russia, Central and Eastern Europe are some 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 there might be investigations or procedures carried-out that 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 investigations, 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 study may cause initiating additional clinical trials.

OCT perform both analytic and descriptive observational studies. 

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 program’s 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 of 12-pr-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”.