Russia – a “Brick” Market for Clinical TRIALS
The Ministry of Health and Social Development of the Russian Federation (MoH) has approved 210 new clinical trials, including local and bioequivalence studies, during the third quarter of 2012, demonstrating a 59% increase when compared to the third quarter 2011.
The main contribution to the total number of studies was made by multinational multi-center clinical trials: their quantity has increased by 11% from Q3 of 2011 and stood at 93 new studies in Q3 2012, and by bioequivalence studies which have grown by 427% (!) from 15 studies in Q3 2011 to 64 in Q3 of 2012. The number of local clinical trials has also significantly grown from 33 to 53 trials.
The share of multinational multi-center clinical trials stood at 44% of the total number of clinical trials in Q3 2012, while the local and bioequivalence studies amounted to 25% and 30%, respectively.
Clinical trials in Russia in Q3 of 2012 were sponsored by companies from 18 countries. The highest number of trials (106) was initiated by Russian sponsors. US sponsors with 30 new studies took the runner-up place, they were followed by the Belgian sponsors with 11 trials.
the British sponsors with 9 new studies. The group of leaders was concluded by French and Swiss sponsors, each having started eight new studies in Q3 2012.
Essentially untapped clinical trial population
Russia is the most populated European country (population - 142,95 Million) with 12 cities having more than 1 Million citizens. Geographically, it spans across nine time zones and encompasses a wide range of natural environments and demographic groups. More than 160 ethnicities reside in Russian Federation, living mainly in metropolis, primarily in the European Russia or in the southwest Siberia.
Optimal clinical trial environment
Fast recruitment and high Data Quality
Another important factor for pharmaceutical and medical device companies to consider when choosing the location for their clinical development program is the spectacular growth of the Russian economy in the recent years. Today Russia is one of the fastest growing world markets for pharmaceutical products and medical devices. And, Russian regulatory authorities require enrollment of Russian patients in pivotal trials in order to allow for domestic new drug registration. Hence, Pharma companies that plan on marketing their products in Russia have additional incentives to choose Russia as a trial location.
Low costs and Growth of Economy
Choosing to work with trial sites on Russian grounds can be a very cost-effective venue. Comparably low investigators' salaries motivate them to participate in clinical trials.
CLINICAL TRIAL LOGISTICS
Russian Customs, Russian geography and Russian climate - these three factors sound restricting when discussing clinical trial logistics. Weeks of customs clearance, many hundreds and even thousands of kilometers between towns and cities frequently come up in discussions and rarely in a favorable light. But what is the real situation?
Let’s review each of the factors:
Yes, there are delays in import and export operations in clinical trial logistics - but what is the true reason? Redundant customs procedures? We believe otherwise. In fact, customs have an obligation to release (or reject) any shipment within 2 days after the customs declaration is registered. Customs also have clear requirements that the importers need to follow - if a problem is uncovered during clearance, then it is likely that something was overlooked when preparing for importation.
Here are some hints on preparing your shipments to Russia:
Cross-reference shipment documentation with the importer prior to dispatch
Make sure you do not make any mistakes in shipment paperwork and make sure that the content of the shipment matches that of the proforma-invoice and of the packing list
Do not ship without approval
Do not ship directly to sites (they just cannot custom clear your shipment!
Make bulk/multi-site shipments to save on costs
Try to make advance shipments, take local requirements into account - some materials will require obtaining of permits and certificates
Ask local professionals about timelines that different types of materials and equipment may require
In fact, properly prepared, cross-referenced and approved shipment should clear the customs within 1-2 days.
Russia is the largest country in the world, occupying a territory of 17 million square kilometers, bordering Poland and Finland, Alaska and Japan. Trans-Siberian railway starts in Moscow and ends in Vladivostok, passing through 7 time zones and is 9259 kilometers or 5753 miles long. A flight between Kaliningrad and Vladivostok takes 11 hours. Yet, clinical trial materials get delivered in 1-2 days. Sounds optimistic? In fact this is a standard situation – clinical sites are concentrated in European part of Russia and in Siberia, which is in the middle of the country and with flights connecting all major cities, deliveries are executed rather quickly. With that being said, we do not want you to disregard a proper advance distribution planning.
Russian temperatures range from +30 C during summer months to -30 C in the winter. However, it doesn't surprise anyone living in Russia - life here does not stop because of heat waves or heavy snowfalls and neither amounts to a national calamity. On the other hand, you would not see tornados, hurricanes or earthquakes in the Russian news - serious natural disasters are rare. With that being said, one needs to use reliable temperature control solutions when shipping clinical trial materials to the sites. To ensure the compliance one should always use an experienced logistics partner with intricate knowledge of the local market.
Focus on: logistics of temperature sensitive and short half-life materials
To ensure that any temperature sensitive product is properly stored and transported through the entire logistics chain, one needs to look at each step of the process separately.
Shipment of materials to local depot
When preparing shipments to Russia, the distributor needs to take a number of factors into consideration: time to delivery of materials to the customs, customs clearance, time to delivery of materials from a bonded warehouse to a local depot, current temperature conditions, etc.
Experienced importer must be able to assist the shipper with selecting the best solution for each particular scenario. The shipper should select the type of validated containers that are designed to keep the materials within required temperature range for a period that exceeds the typical time required to deliver materials to a local depot.
Storage of the materials at the local depot
One of the challenges of local Russian depots is compliance with the international standards. GDP has not been officially accepted in Russia and GMP is viewed as a voluntary local standard. When choosing a local depot, the sponsor must confirm that it is compliant with all international requirements for storage and distribution of clinical trial materials. The local vendor should not only have refrigerators, freezers and walk-in chambers, have installed climatic equipment and temperature and humidity control systems, but also provide validation and maintenance algorithms, have power back-up and comprehensive standard operating procedures in place. However, what is most important is to be assured that the vendor has well-trained, experienced and English-speaking staff members. We strongly suggest a face-to-face visit as part of initial audit of the local vendor.
There are plenty of courier service providers in Russia, but only a few of them have heard about clinical trials and even fewer can guarantee high quality and specialized service – deliver materials on-schedule and within preset temperature requirements. Here are the criteria that should guide your selection of a courier company:
- Delivery timelines - the company must be able to deliver within 2 days, even to the most distant locations
- Availability of temperature control solutions (and its validation)
- Ability to deliver hands-to-hands: if a container is left at the hospital's reception, you will most likely be facing a deviation
- Properly trained and experienced staff, capable, for example, to assist consignee with opening of the container and stopping the temperature logger
One issue that cannot be overlooked when discussing local cold chain logistics is study sites themselves. It is not uncommon for the sites not to have the proper equipment for MP storage – it is often old, not validated, without alarms, locks, or, in some centers, there may not be any equipment at all. One needs to check prior to initiation of the clinical trial on whether rented or purchased equipment needs to be supplied to such sites and to ensure that proper storage procedures are in place.
Another important aspect of doing business in Russia is to understand its local customs. Russia's most important national holiday is the New Year (it is even more revered than Christmas). In accordance with the Labor Law of the Russian Federation, the following days are considered a vacation - December 31 through January 4, and on the occasion of Christmas (celebrated in Russia on January 7) - January 7 and 8. In reality, no one works from December 31st through January 10th.
In 2012, just the official vacation is slated for December 30 through January 8, 2013. Thus, the whole country essentially succumbs to a two-week period of near-total collapse.
During this time the Russians usually do not pay any attention to their work operations (don`t answer the phone or check the emails). Meanwhile, you cannot just put the clinical study on hold for two weeks. This is especially true in clinical logistics. If you did not export biological samples and/or import the IMP or concomitant medications to Russia in advance of the holidays, you are running a significant risk of having problems with the customs clearance. IMP may become trapped at the customs, which means additional costs to the sponsor.
Therefore, in order to have a joyful and stress-free holiday season, we recommend that you plan ahead, choose a reliable vendor and prepare your shipments in advance.
COREX wishes you a Happy Holiday Season!
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