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November 8, 2012
Including Russia and Ukraine in Your Risk Management and Rescue Study Plans

Speakers for this Event:
  • Richard Koenig, Vice President of Operations, ClinStar     Learn More
  • Alina Tatarenko, MD, Senior Project Manager, ClinStar     Learn More
  • Including Russia and Ukraine in Your Risk Management and Rescue Study Plans

    Risk Management is one of the fundamentals of good project management and lagging enrollment is one of the key risks for any clinical trial. It can damage many other key risk areas including: schedule, budget, and quality. Unfortunately, many project leaders and program executives develop contingency plans that inadequately address enrollment risks because they don’t recognize the flaws in the initial strategy and address them. Too many contingency plans seek minor changes to existing strategies, rather than new approaches to impending threats.

    Typical responses to failing enrollment that we see in most contingency plans include:

    • Adding additional sites in the same countries
    • Extending the enrollment timeline - again
    • Loosening the protocol inclusion/exclusion criteria
    • Increasing CRA motivational calls with investigational site staff
    • Increasing site and patient incentives
    • Implementing an advertising campaign

    But have you considered emerging markets? Supporting a failed strategy often results in throwing good money after bad. For many indications, markets in the Europe and North America are saturated with clinical trials and patient enrollment and retention is becoming more challenging than ever. With the lure of large, untapped patient populations, faster enrollment rates and lower drop-out rates, the industry is embracing the benefits of conducting clinical trials in emerging markets such as Russia, Ukraine and parts of Eastern Europe.

    During the webinar, ClinStar Vice President of Operations Richard Koenig will discuss the enormous value and practical considerations of including Russia in your global clinical study planning from the outset, and at a minimum, in your risk management and contingency planning. If you didn’t include Russia in your study or risk management plans from the outset, however, Mr. Koenig will examine how you can leverage Russia and Ukraine in your study rescue planning. Specifically, he will evaluate the critical elements required for a successful study transition plan, including regulatory tasks, drug storage, clinical management and investigator payments.


    Pharma and Biotech staff, more specifically anyone within these organizations who are clinical outsourcing or procurement decision makers or a part of clinical teams such as Sr. Clinical Project Managers and heads of clinical operations.


    Richard Koenig, Vice President of Operations, ClinStar

    Richard Koenig has spent the last 12 years working in clinical research for major CROs. He has worked in a variety of different positions in data management, clinical project management, operations management, and information technology. His most recent experience at his last company included 3 years as the Vice President for Global Information Technology and 2 years of experience as an Executive Director in Clinical Development managing key sponsors and clinical trials. Mr. Koenig has specific experience in the implementation and use of enterprise level clinical and financial systems.

    Prior to working in clinical research, Mr. Koenig spent 15 years working for the US Government in Northern Virginia in IT project management. He has a Masters in Health Care/Public Administration from Long Island University and was selected for a Presidential Management Internship upon graduation. Mr. Koenig is based in ClinStar’s offices in Durham, North Carolina.

    Alina Tatarenko, MD, Senior Project Manager, ClinStar

    Alina Tatarenko joined ClinStar in 2008 and is responsible for project operational oversight. Dr. Tatarenko has over 10 years experience in clinical trials management in different therapeutic areas. She has worked as CRA, Clinical Project Leader, Medical Advisor in CNS, CTMS leader, CROM, and Senior Project Manager at PAREXEL, Aventis, Sanofi-Aventis and ClinStar.

    Dr. Tatrenko graduated from Russian State Medical University.


    ClinStar is a Western managed CRO with local operations in Russia, Ukraine, Belarus and the Baltics. We have 12 years of experience in Phase I-IV clinical trials across multiple therapeutic areas. Unlike many global CROs, we offer a substantial local presence across all areas of operations, providing us with unique local knowledge and personal relationships that benefit your clinical trial.

    From regulatory submissions and clinical affairs to medical monitoring, drug storage and distribution, we offer fully integrated services for managing your trials in Russia, Ukraine and other regions of Eastern Europe. We are best known as a Western CRO in Eastern Europe providing faster patient recruitment and higher quality data than that provided in the West.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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