Welcome to Fisher Clinical Services, Russia. We are very pleased to have the opportunity to share with you our expertise in supporting clinical trials in this country.
There are several reasons why Russia is of interest to international research companies:
• Well established clinical research environment
• Wide spectrum of diseases – oncology, cardiology, respiratory tract diseases, diabetes
• Highly successful patient recruitment rates and retention of patients
• Large, treatment naive population
• A centralized healthcare system with highly specialized medical centers
• Highly skilled clinical staff at investigator sites
• Lower costs. Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
• Faster completion of Phase III CT => getting the drug to market faster => earlier relief to patients, faster return on investment, edge over competition, longer patent protection
• FDA and EMA accept data from Russia
Notwithstanding all of these positive points, there are a few considerations which should be taken into account by companies conducting clinical research in Russia. As with all trials conducted in a country that is foreign to the sponsor, there are Language and cultural differences that need to be considered. and Rregulatory hurdles quite often present challenges to the timeline of a clinical trial. Russia is no different. in Russia.
At Fisher Clinical Services Russia our sole focus is on supporting clinical trials. Through our professional experienced staff, sensitive attention to customer requirements, flexible responses to changes in the local regulations and a constant willingness to serve you, we ensure that your needs are met. Our ability to act as Importer of Record and the processes we have in place to ensure smooth clearance of clinical supplies through customs are paramount to our success in keeping your clinical studies on track.
We invite you to learn more about our facility, services and solutions. Irina Tlyusten General Manager, Fisher Clinical Services, Russia
Fast Facts on the Healthcare Industry:
- A large population of 145M – 78% of the population is concentrated in the European part of Russia, 73% of the population lives in urban areas
- 8th largest economy in the world by nominal GDP and the 6th largest by purchasing power parity (PPP) with enormous natural resources, particularly oil and natural gas
- The value of the clinical trials market was US$ 800 million in 2015
- The Ministry of Health of Russian Federation approved 895 new clinical trials of all types including local and bioequivalence studies during 2016
- The pharmaceutical market is anticipated to grow at a CAGR (Compound Annual Growth Rate) of around 11% during 2012-2017
- The share of Russian-manufactured medicines in the list of strategic medicines and vitally important medicines will reach 90%; 75% of pharmaceutical and 85% of medical companies should be modernized (by 2020)
- Appealing patient pool of treatment-naive patients
- Centralized medical system, with 1099 hospitals entitled to conduct clinical trials
- Fast patient recruitment – Russia is among the top 5 recruiting countries
- The FDA and EMA accept data from Russia.
- In 2015, the Center for Drug Evaluation and Research (CDER) of the FDA approved 123 new drugs, 50 of which were or are being studied in clinical trials conducted in Russia.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) gave positive recommendations on 113 new drug applications, 71 of which were or are being studied in clinical trials conducted in Russia