Full-Service Clinical Trials in Central and Eastern Europe

OCT is participating in ovarian cancer trial.

This is FDA controlled study conducted in 86 sites around the world. OCT is responsible for sites in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria. In total, our CRO is responsible for more than 60 oncology sites across Eastern Europe.75 % of all patients were enrolled in OCT countries. So we can definitely say that the region where our CRO operates is one of the high recruiting countries in the world.

The clinical study is conducted in patients with recurrent epithelian cancer, primary peritoneal cancer or fallopian tube cancer.
At the end of 2011, successful database lock was performed. We are very pleased to meet this important milestone for our client’s clinical development program. In this study we are responsible for

• Clinical Monitoring
• Project Management
• Regulatory
• Clinical Supply Management
• Quality Assurance Services

We will continue to support our client’s clinical program to defeat ovarian cancer. Patients’ enrollment will continue until 650 patients are enrolled.

Ovarian cancer is a disease with few and unspecific symptoms at its early stages, therefore difficult to detect. Unlike certain other cancer diseases the number of patients diagnosed with ovarian cancer increases every year. Ovarian cancer is most often diagnosed in women over 50 years of age, but younger women are also affected. The annual incidence of new diagnosed cases is approximately 125 000 women in EU alone.

OCT is launching a phase IIb/III clinical study in arthritis patients

OCT is preparing for a phase IIb/III clinical trial in patients with rheumatoid and psoriatic arthritis. This will be a multi-center clinical study of efficacy, safety and pharmacodynamics of the investigational product. There will be about 150 patients with the both indication entered in the study.

Psoriatic arthritis affects 5-7% of patients diagnosed with psoriasis. 70% of patients suffer from the joint syndrome after skin reactions of psoriasis, in 15-20% of patients the syndrome develops before skin reactions, and 10% of patients have the both symptoms at the same time.

Rheumatoid arthritis is a chronic autoimmune systemic inflammatory disease of conjunctive tissue, which usually affects joints in the way of erosion-destructive progressing polyarthritis. About 1% of population suffer from this disease. In the world, there are almost 60 mln. RA cases.

In order to recruit patients for this clinical study, OCT plan to have more than 15 sites. OCT have well-developed connections with the specialized clinics not only in St. Petersburg and Moscow, but also in remote cities in Russia, and OCT are going to initiate sites in several cities in Russia. The results of therapy, and efficacy of the drugs will be evaluated according to American College of Rheumatology scale, Disease Activity Score scale, and some other parameters.

OCT was awarded with a bioequivalence trial

OCT completed a phase I/II study in oncology

Clinical trial approval was received for phase II trial in pancreatic cancer

OCT received regulatory approval for two phase I trials in healthy volunteers

CTA for phase II study in gout was performed in Russia

TMF for phase II in a pain study was shipped to the sponsor

Trial approval was received for phase II trial in bladder cancer

Interim analysis has been completed on phase III trial in ovarian cancer, 75% of patients included in the IA were enrolled in OCT countries

Global Partnerships in Clinical Trials held annually in the USA is the largest clinical trials meeting in the world. Annual Partnerships 2012 from 4 Mar 2012 to 4 Mar 2012, will open in Orlando World Center Marriott Orlando, United States. As previous ones, the event is expected to attract lots of professional visitors. With a history of 20 years in the clinical trials outsourcing industry, Partnerships in Clinical Trials is the world's most global event for clinical development leaders and practitioners. Focused on overcoming challenges clinical trials face, PCT is a unique meeting with an expanded focus on insightful education and collaboration designed to drive progress in clinical research. Approximately 2000 attendees representing more than 400 sponsor, CRO and related supplier organizations spanning nearly 50 countries are expected to attend PCT 2012. OCT never lose opportunity of meeting our partners and learning about new industry trends. If you are looking for a reliable result-oriented partner to conduct clinical trials in Russia, Ukraine, Bulgaria, Belarus, Latvia, Lithuania, Estonia, Poland and Czech Republic we would be glad to discuss our potential collaboration with you at Partnerships in Clinical Trials in Orlando. To set up a meeting, please contact us.

OCT will be represented at 21st Annual Partnerships in Clinical trials 2012 by:

Anna Davydova,

Business Development Associate,

e-mail: adavydova@oct-clinicaltrials.com

Since 2007 OCT has been audited by external audits with the regularity of every other month. We are always happy to meet external auditors at our office. Fair and independent audit is beneficial to us in all respects. It is of extreme importance for the management of the company to have independent opinion regarding quality of our work and recommendations to improve.  For OCT it is very important because the company is growing very rapidly and today we are a company of 90 clinical trials professionals who are based in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria.

In January 2012 OCT underwent auditing conducted by the representative of one of the global pharmaceutical companies. The systems review was conducted in two days and involved review of OCT SOPs, staff personal files inspection, staff interviews, facilities inspection and presentations of OCT clinical trials services. No major findings related to company’s Standard Operation Procedures (SOPs), quality assurance system, trials setup and startup, sites identification and initiation, study management of clinical trials, documents management, regulatory services, local IMP management system, Information technology and safety management for clinical trials were noted by the auditor. OCTs Director Clinical Operations and Quality Assurance Managers demonstrated excellent quality and process control, within predetermined budgets and scheduling parameters.

The auditor noted such advantages of OCT clinical trials management as close control of company executives, straight-forward quality assurance system,  simple and effective organizational structure, professionalism  and flexibility at every level. Each project OCT takes on is with the understanding that it must meet all regulatory requirements and must pass our internal compliance checks to ensure success. Obtaining good clinical data from investigative sites is achieved by having the best-trained, highly motivated and dedicated staff on board. Our responsive and experienced people take care of every detail, giving our clients total confidence that all CRO services will be provided by professionals in an efficient manner. Our flexible approach gives us the ability to bring together an outstanding team to meet any requirements.

OCT met an interim enrollment milestone of 50% of randomized patients in a phase II study of a novel drug to treat in Metastatic Breast Cancer.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute.  In 2010, NCI estimated that 207,090 women were diagnosed with breast cancer, while 39,840 women likely died from the disease.

According to official sources, worldwide, breast cancer comprises 22.9% of all cancers (excluding non-melanoma skin cancers) in women.  In 2008, breast cancer caused 458,503 deaths worldwide (13.7% of cancer deaths in women).
OCT client is sponsoring a controlled Phase II trial in metastatic breast cancer (MBC) subjects who have been previously treated with a taxane and an anthracycline.

Planned enrollment is 140 patients, 130 of them will be enrolled by OCT in Russia.  OCT has reached 50 % milestone in the study. The study is being performed in 15 Russian sites. The study is FDA controlled.   We are very pleased to see the progress in the trial and we hope that the study will lead to drug registration afterwards. OCT is working very closely with the sites in Russia to ensure recruitment goals are met, patient care and the quality of the data being collected is excellent.

We have provided the following services in this study:

• Clinical Monitoring
• Project Management
• Regulatory
• Investigator Meeting
• Clinical Supply Management
• Quality Assurance Services
• Study Feasibility
• Safety Management

OCT has been conducting clinical trials in breast cancer since 2006 in different countries of its operation: Russia, Belarus, Ukraine, Latvia, Lithuania, Estonia and Bulgaria. OCT is dedicated to innovative clinical cancer research.

OCT has very extensive experience in oncology:

• We have experience in the following indications:
• Breast cancer
• Prostate
• Bladder
• Bone Metastases
• NSCLC
• Colorectal
• Head Neck
• Ovarian
• Endometrial cancer

Meet OCT representatives at the 30-th Annual J.P. Morgan Healthcare Conference in San Francisco, January 9, 2012 - January 12, 2012.

The pharmaceutical industry's largest J.P. Morgan's Healthcare Conference will feature presentations from approximately 300 companies over four days of simultaneous sessions. This event brings together all established industry leaders, emerging fast-growth companies, innovative technology creators and globally minded service providers. About 10000 participants are going to participate in J.P. Morgan conference this year and OCT team are among them! We would like to invite you to meet with key members of OCT’s executive team to talk about how we can work together.

We look forward hearing from you and most importantly meeting with you in San Francisco!

OCT will be represented at J.P. Morgan Healthcare Conference 2012 by:
Julia Sardaryan (Nedokusheva),
Head Business Development,
e-mail: jsardaryan@oct-clinicaltrials.com

OCT has been granted with pregnancy registry study in patients with multiple sclerosis. This will be a multi-national study. OCT will be responsible for management of 2 centers in Ukraine.

Pregnancy registry is one of the methods to monitor product safety in pregnancy. Clinical trials exclude pregnant women; thus, little is known about the human teratogenic effect of a product at the time it first enters marketing. Multiple Sclerosis is more prevalent in women of childbearing age than in any other group. That’s why MS therapy manufacturers are more and more often required to make post-marketing commitments to conduct studies of the effects of products when used during pregnancy. The drug pregnancy registries are observational studies conducted by pharmaceutical companies to track the effects of certain prescription drugs on pregnancy outcomes when mothers have been exposed to drugs. Data collected on babies born to women taking a particular medicine are compared with babies of women not taking the medicine. These studies provide important information the effect medicines have on fetal development.

The purpose of this Multi-National pregnancy exposure registry in multiple sclerosis is to monitor, evaluate, and assess major and minor teratogenic effects in women exposed to a particular drug during pregnancy in routine clinical practice. The enrollment period for this pregnancy registry is 6 years. During this time we will obtain prospectively and systematically collected data on the potential pregnancy outcome and fetal effects associated with exposure to drugs during pregnancy.

Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. It is caused by damage to the myelin, which forms the protective covering around nerve cells. When this covering is damaged, nerve impulses are slowed down or stopped. No one knows what causes MS. Globally, the median estimated incidence of MS is 2.5 per 100,000. Over 2 million people around the world have MS, including about 200000 Russians and about 20000 Ukrainians.