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| Natalia Fetkovska, MD, PhD, Senior Partner, SanaClis s.r.o., a sponsor company at the marcus evans Evolution Summit 2014, on conducting clinical trials in Ukraine and Russia today. |
LONDON, Sept 26, 2014 - (ACN Newswire) - "Conducting clinical trials in Ukraine and Russia pays off in many ways, but the current situation has brought about certain risks that pharmaceutical companies should plan for," according to Natalia Fetkovska, Senior Partner, SanaClis. "The quality of trials has not been affected at the moment, but the consequences of the conflict are likely to become more apparent in the winter months," she added. As an experienced regional provider, SanaClis would also recommend a mixed country strategy in Central and Eastern Europe (e.g. EU countries and Ukraine and/or Russia).
SanaClis is a sponsor company at the marcus evans Evolution Summit 2014, taking place in Monte Carlo, Monaco, 20 - 22 October.
- What do pharma and biotech companies need to know about conducting trials in Ukraine and Russia?
The major issue today is the geopolitical situation in these two countries, where hundreds of trials are in process or in preparation. The quality of these trials is unaffected but some sites in Crimea and recently also in Eastern Ukraine are slowly closing. Ukrainian health authorities have no control over the sites in Crimea and thus do not approve these sites. The sites in Crimea now fall under Russian legislation and have to be certified by Russian authorities first. For the next year they will not be involved in clinical research. This applies to a relatively small number of sites with little impact on clinical trial conduct.
However, the conflict and war over gas will have a considerable impact on pharma companies and CROs with warehouses that must be heated in the winter months. This is not a big issue now but might certainly become one in the heating period. Apart from our warehouse, I am unaware of any other warehouse in Ukraine with a triple possibility for sustained heating.
- What impact could this have on companies doing trials in the region? What steps should they take?
This means that stability of temperature conditions in the warehouses in Ukraine could become an issue so they must check if they are secure enough. All pharma companies store their investigational products in local warehouses, but do they have long-term backups for gas heating? Our new warehouse was opened in 2012 and it was built with respect to a gas conflict between Ukraine and Russia in 2009, so it has the capability to be heated by gas or electricity, with generators as a backup. This is not the case in standard leased warehouses which do not have direct control of all processes and leased systems.
In addition, US and EU sanctions have been imposed on some transportation companies and banks. Pharma companies should check if investigators and other local providers have accounts in those banks, as that could affect clinical trial conduct. They should also check where IT servers are placed. Do they have backups in another country?
Trials can and should be done in Ukraine and Russia as not many countries have such a large pool of compliant patients and motivated professional investigators. Logistically it may be slightly harder to do studies there right now, but the effort pays off with quality, patient numbers and cheaper cost per patient.
SanaClis as an experienced regional provider would recommend a mixed country strategy in Central and Eastern Europe (e.g. EU countries and Ukraine and/or Russia).
- As one of few service providers offering customs brokerage, warehousing and distribution of clinical trial materials, besides clinical monitoring and regulatory services, what would you say benefits pharma companies?
Normally, a company doing a trial in Russia or in Ukraine would have one partner handling customs and brokerage, another company or CRO responsible for getting the import licenses, one for the warehouse and another for distribution. When there are five different logistics partners involved, communication can become quite complicated and time consuming. A pharma company could save a lot of time and money, and avoid many misunderstandings, if local logistics was all handled by one organisation.
About the Evolution Summit 2014
The 13th annual Evolution Summit is the premium forum bringing elite buyers and sellers together. The Summit offers clinical research leaders and global CROs an intimate environment for focused discussion of key new drivers shaping drug development strategies. Taking place at Le Meridien Beach Plaza, Monte-Carlo, Monaco, 20 - 22 October 2014, the Summit includes presentations on evolving CRO alliances, boosting pipeline productivity, bridging pre-clinical and clinical trials, site selection and improving clinical trial timelines and outlines.
For more information please send an email to info@marcusevanscy.com or visit the event website at www.evolution-summit.com/NataliaFetkovskaInterview
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About SanaClis
SanaClis is a contract research organization (CRO) offering a comprehensive range of services to support the drug development process in CEE region.
SanaClis Clinical, IP & CTS Management, Data Management & Biostatistics departments provide high quality services to support the clinical development of drugs and medical products. Regional knowledge, experience and the use of powerful and efficient validated equipment and CTMS, CDISC Certified & regulatory compliant EDC software suite and services of professional biostatisticians enable our team to deliver top quality data on-time, within budget and help to avoid delays in the clinical research process. Our clinical experts and statisticians work closely with the DM Team to meet the needs and objectives of each specific project, providing every time a customized service. SanaClis is an active member of the CDISC organisation. www.sanaclis.eu.
Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager, marcus evans, Summits Division
Tel: +357 22 849 313
Email: press@marcusevanscy.com
Topic: Press release summary
Source: marcus evans Summits
Sectors: Daily Finance, Daily News
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