moscow
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
Importer-of-Year-2014
Fisher Clinical Services LLC, Moscow, Russia announced its acceptance of an “Importer of the Year 2014 Award” from the Russian Federation. This award is granted by the Russian Federation, based on official statistics and in recognition of the following categories:

  • The amount of foreign trade operations
  • Dynamics of growth in foreign operations
  • A diversification (the number of trade positions)
  • The number of counterparty countries importing into Russia

The number of clinical trials in Russia has been expanding rapidly over the past decade. According to the Q1,2014 Orange Paper, the Russian Federation Ministry of Health approved 169 new clinical trials of all types including local and bioequivalence studies. Clinical trials in Russia in Q1, 2014 were sponsored by companies from 22 countries. (1) The country has grown in popularity as a site for clinical studies for several important reasons. Most clinical research associates in Russia hold degrees in medicine; patients with previously untreated disease are more easily found than in North America or Western Europe, and large, purpose-built, healthcare institutions are eager to participate.(2) Yet language barriers, an insufficient infrastructure, and regulatory hurdles can make trial conduct notably complex.

Irina Tlyusten, General Manager of Fisher Clinical Services, Russia says: “At Fisher Clinical Services Russia, we work diligently to support pharmaceutical and biotech companies wanting to conduct clinical research here. 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 meeting the needs of our clients and in keeping clinical studies on track. We are proud to accept this award.”

About Fisher Clinical Services
Fisher Clinical Services is exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. With exposure to large multinational trials and thousands of protocols every year across all therapeutic areas, Fisher Clinical Services has developed the industry’s best practices in clinical supply chain management. Fisher Clinical Services is part of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $17 billion, we have more than 50,000 employees in 50 countries and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industry process control settings.

References:
Clinical Trials in Russia, Orange Paper, 1st Quarter 2014. Synergy Research Group, Moscow, Russia.
Platonov P. Clinical trials in Russia and Eastern Europe: recruitment and quality. Int J Clin Pharmacol Ther. 2003 Jul;41(7):277-80.

moscow-irina
Dear Customers and Friends,

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. Regulatory hurdles quite often present challenges to the timeline of a clinical trial. Russia is no different.

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
moscow
Gateway to 142 million patients and one of the fastest growing clinical markets

Russia Fast Facts:
Location: Center of European Region of Russia
Population: 12 million
Nearest Airport: Domodedovo International Airport (DMO)
Distance from Airport(s) to Facility:
Domodedovo International Airport (DMO) 40km
Sheremetyevo International Airport (SVO) 85km
Vnukovo International Airport (VKO) 50km

Fun Fact: Up to XIX century the Moscow Kremlin was “white” as the red walls of the Kremlin were whitewashed to protect the bricks, but the paint was stripped after the Great Fire of Moscow in 1812 and this is the Kremlin we see today.

City:
Moscow
Country:
Russia
Opened:
2010
Total Capacity:
2,803.4 m2
Secondary Rooms:
3
Cold Production Rooms:
1
Warehouse Capacity:
15,493 m3
Refrigerated Storage Capacity (2-8):
808 m3
Frozen Storage Capacity (-20):
95 m3
Frozen Storage Capacity (-30-50):
374 m3
Frozen Storage Capacity (-60-80):
374 m3
Environmental Technologies:
Yes
Audited:
Russian License Authority
Comparator Sourcing:
Yes
Returns & Destruction:
Yes
Labeling:
Yes
Secondary Packaging:
Yes
moscow-benefits
Key Benefits for Sponsors:

  • Established in 2010 with a track record of excellence
  • 550+ studies to date
  • 80,000+ shipments to date; 99.8% On Time Delivery
  • Cold chain management expertise
  • Validated ambient, refrigerated and frozen storage capacity
  • Controlled temperature storage
  • Supply of insulated shippers and temperature monitoring devices
  • Global SOP’s / Global IT systems
  • Consultative Project Management
  • Technical and Regulatory advice
  • Import Support – facilitated 1,000+ IORs to date; payment of customs fees and duties
  • Comparator sourcing, purchasing and distribution
  • Ancillary sourcing & kit assembly
  • Secondary packaging and extension labeling operations
  • Certified Returns & Destruction service
  • Backup generator
  • Security – 24 hours / 7 days
  • Making the clinical trial supply chain simpler and safer in Russia

When time does matter

The employees of Fisher Clinical Services Russia arrange more than a thousand shipments each month. The case below shows how we take extraordinary measures to ensure each clinical trial supply kit gets to the right patient on time.

Challenge
Our client, a U.S. pharmaceutical company, asked us to arrange an urgent shipment from Moscow to St. Petersburg. The greatest challenge of the request was that it was received over a 5-day national holiday (May 1st-5th) and the patients needed the drug urgently.

Solution
The Fisher Clinical Services manager who received the holiday request at 2:15 am (Moscow time) replied to the query less than an hour later. The Fisher Clinical Services team then discussed the issues, agreed on a strategy and organized overtime production shifts. Both project managers and warehouse operators came to work over their holidays. The incoming cargo was removed from quarantine, quickly verified, and the data were downloaded into Fisher’s Global Project Management system in order to arrange the urgent dispatch of the shipment in the required timelines. As a result, the patients received the medicine in time and the clinical trial stayed on track.

Overview
Thursday, May 2, 2013:
Fisher Clinical Services Russia was contacted with an urgent request.Friday,

May 3, 2013:
The manual order on shipment was received from client.Saturday,

May 4, 2013:
Goods were verified and data downloaded into GPM system.Sunday,

May 5, 2013:
Outgoing shipment was arranged.Monday,

May 6, 2013:
Shipment was delivered to site. The Client was very pleased by the way Fisher Clinical Services Russia flawlessly conducted the clinical supply work during a major holiday weekend.

Client’s feedback:
“Fisher Clinical Services has put in extraordinary efforts to ensure availability of clinical supplies to patients.”

How we meet customer requirements

A large multinational pharmaceutical company approached Fisher Clinical Services with a request to purchase and install equipment for storing pharmaceutical products in temperatures ranging from -40°C to -60°C. Additionally, the Client required application of their pick and pack procedures and their own shipping materials, which differed from those Fisher Clinical Services uses worldwide.

The Client’s needs specifically included:

  • Purchase and validation of 2 upright freezers;
  • Purchase and validation of 2 incubators for preconditioning cool elements;
  • Importation of the temperature guns and their further calibration;
  • Purchase of a paper dunnage pack machine;Using client`s procedures for dispatch of site shipments.

Development
After checking numerous options for sourcing incubators and freezers, the Fisher Clinical Services team installed the equipment in an expedited fashion. As a next step, the new equipment was validated and connected to an internal system that controls the temperature ranges in the warehouse.

Temperature guns were imported into the country; and a local service provider was secured for the annual calibration tests.

All internal processes related to the Client’s shipment flow were updated in accordance with Client needs. All involved personnel were trained including both the distribution and warehouse teams.

Customer Satisfaction
Fisher Clinical Services took into consideration all aspects of this complex project. Specifications and instructions determined by the Client were carefully followed.

The project took about 4 months from the moment the requirements were approved by the customer to the moment the equipment was installed and processes were changed.

The Sponsor is very happy to have all of its requests fulfilled within the short timeframe and is currently planning to use the expanded cold chain equipment for new clinical trials.