The Current Climate of Clinical Trials in Russia and Ukraine | Page 17

Clinipace Experience
The entry into the clinical trials market in Russia and
Ukraine benefits from locally based knowledge of
regulatory requirements and the common issues when
applying for or conducting clinical trials, in addition to
making payments and arranging contracts.
Clinipace Worldwide is a multinational CRO with
offices located in Russia and Ukraine, and the teams
include medical doctors, psychiatrists, neurosurgeons,
pediatricians, dermatologists and intensive care
specialists, all with clinical experience as well as
clinical trial experience in their respective countries in
cardiovascular, hematology, oncology, endocrinology,
allergology, pulmonology, rare pathology,
gastrointestinal disease and many other
therapeutic areas.
The teams’ previous relationships with institutes and
principal investigators and the ability to communicate
“doctor-to-doctor” with the investigators facilitates
identification of appropriate study sites and knowledge
of the registries for rare diseases, some of which are not
publicly known or readily available.
During submission, the assistance of the Russia
office with translation of documents into Russian is
invaluable, particularly considering that this remains
an issue. The MoH in Russia often has additional
questions because of poor translation, delaying
the approval process. Specialized local translation
companies with whom Clinipace has partnerships
provide high-quality translations that are generally
better than those from large international companies.
The Clinipace team can also provide a final review of
the documents to ensure the translation
before submission.
With the evolving regulatory environment in Ukraine,
it is particularly important to have locally based
knowledge regarding the current requirements and
expected changes. The strategies outlined in the
national strategy will be implemented in phases, with a
number of emergency measures implemented during
2015 and 2016, followed by an adaptation period
lasting two to three years.30 While these reforms do
not preclude clinical trials and in fact will facilitate
consistent clinical trial processes with other countries,
they are extensive and wide-sweeping, making them
difficult to monitor from outside the country.

Common Regulatory Issues in Russia:
• DOCUMENTS MUST BE SUBMITTED IN
RUSSIAN; English is not acceptable.
• THE QUALITY OF TRANSLATION IS VERY
IMPORTANT; we have found that the cost
of the translation does not always correspond
with the quality.
• THE MOH AND THE CENTRAL ETHICS
COMMITTEE read the documents very
carefully and do not miss any mistakes.
• FOLLOW RECOMMENDATIONS FROM
THE MOH during document preparation.
Some requirements are different from other
countries.
• ALL PAYMENTS TO MOH should be in rubles
only.
• CARE MUST BE TAKEN WHEN PLANNING
PAYMENTS to investigators and hospitals.

Summary
Russia and Ukraine represent emerging markets with
great potential for clinical trials and largely untapped
patient populations. Having local experts on the
ground is crucial to the success of trials in
these countries.
There may be some challenges during the transition
period as the regulatory environment in Russia
changes to address ongoing concerns about conduct
of clinical trials and provision of health care and to
align better with the EU. The current reforms to the
health-care system in Ukraine will result in drug laws
and regulations for clinical trials that are very similar to
those in Europe. However, a CRO with an established
presence in the country and local experience and
knowledge can help to maintain currency with the
regulatory changes and identify the most appropriate
and best sites, investigators and patients for
each application.
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