White papers and case studies

As the the recognized leader in medical translations, ForeignExchange Translations shares insight and opinions with others in our field. Feel free to download and share our white papers on the following topics:

• Clinical research
  
• Manufacturing
  
• Regulatory affairs
  
• Risk management
  
• Training
  
• Translation and localization

Clinical research

• ISO 14155:2011 – an overview (163K) As both clinical trials and the regulations governing them become more complex, it is essential that companies have systems in place to review—on a regular basis—the regulations of the countries in which they are working and to update their standard operating procedures to match.
• Why is India irresistible for clinical trials? (107K) India, with its booming economy, huge population, and large pool of well-educated, English-speaking medical professionals is rapidly becoming a preferred destination for clinical trials. India’s economy is growing at an annual rate of about 8%—second only to China—and healthcare and pharmaceuticals are among the fastest growing sectors.
• Regulatory considerations for clinical trials in Central and Eastern Europe (111K) Central and Eastern Europe—the countries of the former Communist Bloc and Soviet Republics—are attractive destinations for clinical trials in terms of cost and low cultural barriers to doing business.
• Clinical trial success in Latin America (140K)
  Latin America, with its large urban population and wealth of well-qualified medical professionals, is becoming a preferred destination for clinical trials. From 2005 to 2008, regional participation in clinical trials increased by an eye-popping 30.7%.
• Adapting patient recruitment to global cultures (126K)
  Patient recruitment is an increasingly difficult challenge for sponsors of clinical trials and is made even more complex when a study is done on an international—or even global—scale. At the same time, study implementation depends on timely recruitment of appropriate subjects.

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Manufacturing

• Maximizing productivity among Spanish-speaking employees (112K)
  When working in any sort of multicultural environment, it is important to realize that people from different backgrounds approach fundamental issues such as communication, personal relationships, and success quite differently.

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Regulatory affairs

• Are you complying with the 2010 Amendment to the EU Medical Device Directive? (146K)
  In order to create a single market within the 27 countries of the European Union, the European Commission—the executive body of the EU—drafts regulations to harmonize legal requirements, which are then accepted or rejected by the European Council.
• Human Factors Requirements and Usability Testing for Medical Devices (280K)
  In this paper we will discuss why human factors engineering (HFE) has become so important, the most recent guidance documents on human factors requirements, and why faulty studies or documentation can result in regulatory rejection letters. We will also cover ways of incorporating usability testing into the various stages of product design and details on specific recommendations for usability research.
• EU Medical Device e-Labeling, Compliance, and Software Requirements (109K)
  Labeling plays in important role in the marketing of medical devices because labels—as well as instructions for use (IFU)—come into direct contact with the consumer.
• Working with Japan: a process for cooperation in regulatory affairs (329K)
  A case study that examines how process improvements can improve collaborative efforts in the creation of Japanese Regulatory submissions.
• Securing regulatory approval for IVDs in China (293K) In order for companies to set a clear and realistic China strategy for registering IVD products, they need to understand the regulatory environment in the PRC. In this paper, we will provide an overview of the regulatory system, note recent changes in the regulatory environment, and describe the registration process with a focus on the elements unique to China.
• Finding labeling solutions (1.3mb)
  A case study covering improvements to a workflow management process that greatly improved our client's efficiency and time to market.
• A systematic approach to Japanese medical device submissions (115K)
  Japan has an 18-billion-dollar market for medical devices, with 40% of the current market held by imports. While this represents a major opportunity for device manufacturers, taking full advantage of the Japanese market requires careful preparation as well as thorough understanding of the regulatory system.
• EU language requirements (90K)
  Do you know which languages are needed in which European countries? Some of the requirements may surprise you. Click here to receive a chart of the EU countries and their language requirements.

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Risk management

• Advanced Human Factors Engineering (181K)
  Because usability testing of medical devices is mandated by the FDA and other global regulatory bodies it is essential for companies to know how to manage the usability testing process. In this paper, we will provide a step-by step analysis for assessing and mitigating use errors in preparation for regulatory filings.
• Medical device risk management - best practices for implementation (152K)
  Implementing risk management into the development process has become a regulatory necessity. However manufacturers still struggle to not only fulfill the requirements of ISO 14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way. This white paper answers some of the tough questions and gives helpful tips for a successful risk management implementation.

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Training

• Business without borders: working across global offices (93K)
  Thanks to advances in technology, transportation, manufacturing and the increased spending power of the global consumer, companies are rapidly expanding into the global marketplace.
• Social media in the life sciences: what you need to know (99K)
  An explosion of social media outlets has enabled an unprecedented level of information to flood the market. The same technology that drives this growth represents a challenge to organizations trying to maintain control of their corporate messaging.
• Communicating Complex Technical Information to Non-Technical Audiences (106K)
  Complex technology is at the core of most industries, including electronics firms, software startups, and—of course—in the medical and pharmaceutical field. However, both non-technical personnel in these areas, as well as clients and customers, often “tune out” as soon as a discussion takes a technical turn, in the (usually) mistaken belief that they won’t understand what is being said. At the same time, technical subject matter experts often dread presenting information about their work
• Recording and translating audio for e-learning (108K)
  With an increasing amount of training being done over the Internet or Intranet, knowing how to develop material for e-learning has become an important skill. In this paper, we will look specifically at preparing audio material (i.e., narrated material without video) for online courses.
• E-learning without borders (321K)
  Smart authoring and programming upstream can save time and money in translation.
• Streamlining the Flash localization process (126K)
  Many of the features that contribute to Flash's overwhelming success have also made it difficult to use during localization. Our white paper provides easy-to-use tips and tricks.
• Using learning styles to successfully engage all learners (215K)
  One of the greatest challenges facing any organization is providing appropriate settings for people in which they can make maximum use of their talents. This is true at the team and department levels, as well as in companies overall.
• Internationalizing training programs (145K)
  Today, global drug and device companies are moving aggressively toward computer-based training. Driven by an increased need to rapidly provide consistent training across an international audience, this trend is accelerating in light of reduced travel and training budgets brought on by the current recession.

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Translation and localization

• Perils of translation quality validation in international labeling (363K)
  Every single day another international labeling project is setup with its highest element of risk smack dab at the end of the project. Quality validation is hugely important, that goes without saying, especially in regulated industries.
• The Importance of Editing (118K)
  Translators are amazing people. To borrow a simile used in another context, we could say that they are the Ginger Rogers of the written word: they do everything writers do, only with linguistic demands equivalent to dancing backwards in high heels.
• In-Country Review: Who is the King of Quality? (141K)
  The king has all authority and power over his subjects. He makes pronouncements from his throne—reasonable or unreasonable, right or wrong—that must be followed.
• Optimizing In-Country Review (468K)
  A common path to the goal of validating language translation quality is often down the road of in-country review. There are several good reasons to perform in-country review: compliance to regulatory standards; confirm the quality of a translation; and to ensure technical accuracy.
• Language facts: Bahasa Malaysia and Bahasa Indonesia (392K)
  The islands of Southeast Asia have, for centuries, been a global hub of travel, trade, and commerce. As such it has developed into a myriad collection of peoples, cultures, and languages.
• The role of translations in EMA submissions (388K)
  Before a new medicine is admitted to the European market, an application for marketing authorization must be submitted to the European Medicines Agency (EMA). Part of the submission dossier for this application is the Product Information document, which must be made available in the languages of all countries where the product will be marketed.
• Language facts: Maltese (220K)
  The huge increase in demand for professional Maltese translations (think centralized procedure, product labeling, not to speak of official EU business) has resulted in a chronic shortage of Maltese translators. As recently as 2009, the EU Commission singled out Maltese translators as "particularly difficult" to recruit.
• Translation & Linguistic Validation of Patient Reported Outcome Measures (283K)
  In the following paper we will focus on the translation and linguistic validation of patient reported outcome measures. Issues to be covered include a presentation of the methodology used at some major companies and the specific steps involved, as well as the practical aspects clients should consider when thinking about managing and running a translation project for a particular compound.
• Doing Business in Japan: Lessons from a Road Warrior (221K)
  Doing business in Japan—where cultural practices are quite different than in the West—can be challenging, but approaching the Japanese with an open mind and taking advantage of the tips and suggestions given below will help make trips to Japan enjoyable and successful.
• ASTM F2575: A Practical Guide for Achieving Translation Quality (262K)
  Across any industry, a customer reviewing proposals for business services will hear promises of lower prices, faster turnaround times, higher quality or better service. The challenge for many customers is to determine which of those service providers will follow through on any of those claims of superior performance.
• The languages of Spain (65K)
  Saying that everyone in Spain speaks Spanish would be a statement as simple as saying that all Spaniards do siesta, eat paella and drink sangría. While this may be true for many Spaniards, it is not accurate for all of them.
• Language facts: Chinese (76K)
  Chinese is a lovely and fascinating group of languages. We hope this quick overview of linguistic facts will make people want to learn more about this group of languages.
• Budgeting for translations (322K)
  Budgeting doesn’t have to be such a crystal ball exercise if you identify your variables, project types and use metrics to get estimated costs. In this way, it becomes more of a methodical scientific process and one that can yield accurate forecasts, great ideas for cost savings and happy upper management.
• Measuring translation quality (326K)
  A white paper that explains how measured translation quality can actually lower costs and turnaround times while increasing quality of deliverables.
• EN 15038:2006 – an overview (247K)
  Have you struggled with a good way to assess the countless translation agencies vying for your business? Or maybe you’re looking for a way to assess your current provider. Well, you’re not alone.
• Writing and designing for an international audience (279K)
  As more companies aim at international—or even global—exposure for their products, there is a growing need for ready advice on how to write and design across borders. While the task of preparing documents for use in a variety of linguistic and cultural settings may seem daunting, careful planning and systematic execution can ensure success.
• Secrets of successful website globalization (236K)
  While the practice of Web production has matured over the past decade, the practice of Web globalization is still very much in its infancy.
• Universal Spanish (222K)
  Spanish is the most translated language in the US. While Spanish is one of the easier languages to learn, technical texts are often considered difficult to translate into Spanish. One of the main reasons given is that there is no single variety of Spanish. There are, in fact, major differences between the Spanish of Spain and, say, South America.
• Growth of non-English languages in the U.S.A. (117K)
  The U.S. population is becoming increasingly diverse -- with many who speak English as a second language, or speak little English at all. This presents significant opportunities for U.S. companies looking to expand revenues and profits domestically.
• Evolving entities: the languages of former Yugoslavia (110K)
  The languages of former Yugoslavia are all South Slavic in origin. The South Slavic languages are divided into Eastern and Western branches, which then diverge further based on distinctive dialects.
• The languages of India (126K)
  In India, language is one of the main components of a person's ethnic identity. Furthermore languages, and thus individual identities, are both numerous and expansive throughout the Indian nation. The Indian constitution currently recognizes 22 official languages.
• Translation and back translation in the drug industry (109K)
  The expanding global market for pharmaceuticals is requiring drug companies to translate their product information, labels, informed consent forms, and other printed material into various languages in order to be understood by the end user.

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