Presented by Inna Kassatkina at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis, IN. Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects’ human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process. * Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management – from regulatory, financial, and efficiency perspectives. * Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.

1. Inna Kassatkina, President Email: [email_address] Tel: (949) 798-1400 www.globallanguages.com Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges

4. Growing Need for Language Translation Projection : the global pharmaceutical market will double over the next 12 years (to $1.3 trillion) 1 Facts: 47 million people, or 18% of the total U.S. population aged five and over, speak languages other than English at home. Since 1990, the number of non-English speakers at least doubled in six states: Nevada (193 %), Georgia (164%), North Carolina (151%), Utah (110%), Arkansas (104%), and Oregon (103%). 2 Commonly Known Fact: Hispanics are the largest minority group in the U.S. – 41.3 million people as of July 2004. 3 Question: Do you know the second largest non-English speaking minority group in the U.S.? How about in your own state? Sources: 1 PricewaterhouseCoopers, “Pharma 2020: The Vision” 2 U.S. Census 2000 3 U.S. Census Annual Report released on June 9, 2005

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