Medical Translation Insight

We’ve got some great educational offerings in the coming weeks.

Writing for a Global Audience – Minneapolis
We will be hosting a complimentary Learning Unplugged seminar in the Twin Cities area, “Writing for a Global Audience.”  This two-hour complimentary seminar is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker will explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.

The event will be held from 8:30 until 11am on June 20th at ForeignExchange’s Bloomington, MN office. You can get more information and sign up here:
http://info.fxtrans.com/lu20120620-writing-for-a-global-audience-mn/

Introduction to Translation Memory – Santa Clara
On June 28th in Santa Clara, we’re presenting an overview of Translation Memory technology. This seminar focuses on the mechanics, uses and limitations of Translation Memory. It will also cover guidelines for how you can get the most out of Translation Memory to maximize quality, minimize spend, and reduce turnaround times. Our presenter, linguist Gabriela Herce, will also show a demonstration of how Translation Memory works.

This complimentary event will be held from 8:30 until 11am at Santa Clara’s Biltmore Hotel with a light breakfast and time for networking. You can get more information and sign up here:
http://info.fxtrans.com/lu20120628-an-introduction-to-translation-memory-ca/

ForeignExchange Translations has partnered with ASCA Corporation of Osaka to offer seamless localization support for companies doing business in Japan. While ForeignExchange has long provided Japanese translation services, we recognize that Japan is a highly nuanced market, from regulatory affairs to clinical trials to marketing. ASCA Corporation, which is based in Japan, has long been a leader in drug and device translation and localization, supporting top companies from one end of their product life cycle to the other.

The strategic alliance between ASCA and ForeignExchange provides medical companies with a unified solution for their global localization needs, and the confidence that their Japanese content will be of the highest quality. But this partnership goes beyond localization. We also can provide process improvement consulting, cultural training and document creation services. Our collaborative approach with ASCA draws on the experiences and strengths of both companies while providing a unified experience for our customers.

According to ForeignExchange president, Andres Heuberger, "ASCA is a company guided by many of the same principles as ForeignExchange and their commitment to saving lives in Japan through accurate, timely translations makes them a logical partner. We're extremely excited to work with ASCA in this important market."

Visit our Website to find out more about ourJapanese medical translation capabilities.

Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.

Adobe Flash is still one of the-most use tools for elearning and computer-bsaed training programs. And who knows better about localization best practices than the developers?

Adobe's globalization team recently posted the outcome of an extensive study undertaken to identify best practices in localization of Flash-based content. Starting with creating the English content so that it becomes localization "friendly", the article shows how users can realize cost and time savings.

The take-aways and best practices are worth noting by corporate training groups and medical translation suppliers alike. For example:

"Keep the number of text layers within Flash project as low as possible. If any text formatting is required, do it only one text layer (as much as possible)."

And:

"For any localizable text within a graphics (graphical text), it is important to provide source English assets. If source editable asset is not provided, it has to be re-created..."

Now, that is sound advise and often ignored (or not known) by training program developers.

So, head on over to the Adobe Globalization blog for their useful Adobe Flash Localization Guidelines.

Of course, Flash isn't the only tool out there. Take a look at these other resources for more useful insight into the translation and localization of training materials:

• Localization Tools for eLearning: Articulate, Flash and Captivate
• Implementing a Rapid e-Learning Development Tool
• Updating Training Content Dynamically
• Video Production and Localization for eLearning
• Recording and Translating Audio for eLearning

ForeignExchange provides specialized medical translations for training courses developed by pharmaceutical and medical device companies. Contact us to find out more!

Are you planning to attend the SPBT 2012 Annual Conference in New Orleans next month? If so, we hope to see you there!

It's been a couple years since we visited the Society of Pharma and Biotech Trainers Conference but we’re excited to go back in a couple weeks. Training and eLearning localization for drug and device companies is one of ForeignExchange's core competencies, and the SPBT conference is a perfect place to get caught up on the trends in the field.

ForeignExchange will be at Booth 809 in the exhibit hall at the New Orleans Hyatt Regency. Feel free to stop by to say hello and speak with us regarding any plans you may have to internationalize and translate your training programs. We look forward to seeing you in New Orleans!

If you’d like to learn more about ForeignExchange’s training capabilities, check out this link:
http://www.fxtrans.com/services/advertising-translations/training-translations.aspx

Quality is a given in medical translations. Sure, clients care about money, and turnaround is becoming increasingly important too. However, if a medical translation provider cannot guarantee quality, pretty much nothing else matters.

And with good reason. The absence of quality in translation can easily lead to law suits, product recalls, and can even endanger patients' lives.

More and more drug and device companies are realizing that in those situations, "going after" a typical translation providers yields scant compensation - some PCs and desks and a bunch of receivables. In other words, nothing that a top 100 drug and device company would be interested in.

More and more of our clients are now insisting that we carry professional liability insurance. This "errors & omissions insurance" provides coverage for mistakes or negligence. One financial Web site says that E&O insurance "can help protect a company against claims for financial injury that allege a product failed or the company failed to perform services, causing a loss of use of tangible or intangible property to others."

Lots of folks decry this trend as a shocking and a clear sign of how our society is becoming more and more litigious. That may be right or it may be the equivalent to fighting windmills.

But a recent article in tcworld argues that the trend to risk analysis (and risk management) is a positive one for the translation industry. In Translation and liability, the author opines that many translation providers try to take the easy way out (by not including their Ts & Cs in a contract) and not thinking about liability issues because they think by disavowing an liability, they will be covered. (But can a few paragraphs in the contract really restrict the liability to the client?)

Most interesting, though, is the author's view that instead of E&O insurance, it is the authoring process that should get the attention of translation clients:

"The most important instrument for avoiding liabilities resulting from general mistakes in the instructions, is within the documentation itself: Make sure you have experienced and trained technical editors producing the documentation and that they have made it easy to understand. We all know that documentation dictated by engineers and developers may be filled with strange terminology and lengthy sentences. Such a documentation can definitely not be translated without errors, regardless of how good the translator might be and regardless of how many drinks he might have had or not."

Good advice - that will probably fall on deaf ears at corporate procurement and legal departments. Nonetheless, while medical translation providers won't be able to do without E&O insurance anytime soon, their real protection comes from helping clients improve their source materials.

For more on this topic, take a look at:

• International labeling is risky business
• Quality matters, or: Is risk a four-letter word?
• Patent translations - inherently risky?

For expert medical translations of regulatory, clinical, and marketing content, request a detailed proposal from ForeignExchange Translations.
 

Yesterday, we looked at the China (and India) through the lens of IVD manufacturers. Today, we are still looking at China but on the topics of clinical research and, especially, bioethics.

By way of background, bioethics, according to Wikipedia, is:

...the study of controversial ethics brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy.

When applied to China, some may argue that bioethics is an oxymoron.

Earlier today, Pharmalot's article China, Bioethics & The Wild West: Joe Explains made just this point. Noting the vast differences between East and West, interviewee Joe Powers (the "Joe" in the article's title) gave the following example:

Take a sense of autonomy, for instance. We're used to a system where the individual has the right to consent to a clinical trial or a treatment and to understand what they're going through and to be able to get out without coercion. In China, this can be very different. A family member may make decisions. There are cultural taboos in connection with certain diagnoses. A doctor is inclined not to tell a patient they have cancer and instead will tell a family member. And they'll tell the patient that they're fine... In China, a patient may enroll in a clinical trial because a physician may have coerced them or they may refrain from seeking information – all out of respect for the physician. The patient dynamic can be very different. And these are differences we take for granted, but make it challenging for running trials in China...

Oh my, those Chinese... just look at how crazy things are over there!

Or are they?

Instead of China being "crazy", could it be that the Western view of bioethics is wrong or, at least, just self-serving? One of the commentators questions the assumption that the Western standard is right, that the Western view of autonomy for example has the right to supersede a standard accepted in that society for millenia and says that it "[r]aises a question where colonialism and a sense of colonial superiority is alive and well versus the Western assumption that the "modern" global standards really are superior."

A simple and fascinating question. What do you thing, gentle readers? Is there an "absolute" standard regarding bioethics or is it just another example of the West trying to impose it's mores and norms on the rest of the world?


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India and China... Both countries are inspiring success stories and, according to a new article, are positioning themselves to play major roles in the global in-vitro diagnostics (IVD) market in the future.

China and India: Comparing Two Fast-Growing IVD Markets is a timely look at how these two countries that account for about 1/3 of the world's population stand to up-end the IVD industry. While IVDs aren't the only products feeling the heat from "Chindia", those products have seen annual growth rates of 10-20% in the recent past.

The IVD Technology article does a nice job looking at market sizes for IVD instrumentation, molecular testing, and clinical labs. It notes differences in experiences and with product registrations, for example, highlights differences:

IVD product registration is an area in which the two countries differ greatly. Product registration is going to get more difficult in India, but it still remains relatively inexpensive and rapid. India's government is making changes in the regulations for medical devices and IVD products. According to industry contacts and Ministry of Health officials, a notification is expected that would bring a group of medical devices and IVDs under the regulatory framework. The authority regulating medical devices and IVDs will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health.

In China, the situation is very different. The State Food and Drug Administration (SFDA) is responsible for regulating drugs and medical devices. Both IVD instruments and reagents must be registered, and all products must be re-registered every four years.

If you want a piece of good news, then jump to the end of the article, where the author concludes that "[a]s long as the two main market drivers—increasing prosperity and urbanization—continue, strong growth in the Chinese and Indian IVD markets is expected for many years." [Hat tip to Mel Faux!] For more on this topic, take a look at:

• China's IVD market is booming
• Medical devices & IVDs in the world's 2nd largest economy
• Growing importance of India, China for medical device, pharmaceutical firms

ForeignExchange Translations provides specialized software localization and regulatory translation services to medical device and IVD companies. Contact us to learn more.
 
 

We've said it before: Readability is important when it comes to clinical studies.

While informed consent forms (ICFs) are required in all clinical trials which are approved by an independent Ethics Committee, most ICFs are too complex to understand by an average adult patient. One obvious solution is to reduce the complexity and increasing the ease of readability.

While this has been advocated for quite a while, clinical researchers have largely resisted efforts to encourage investigators to participate in the preparation of ICFs, gain an enhanced understanding of the site specific requirements (culture, language and dialect, literacy rate, and so on), and, of course, improve deficiencies in the translation process.

Despite this foot-dragging, pressure has been growing on researchers to improve communications to trial participants. Adding even more pressure is a recently published report which states that preparing lay studies is not just feasible but generally easy to do.

For the report, technical clinical results for two drugs was rewritten in layman's language. Extra touches were added, like sending thank-you cards to volunteers and updating them on the progress of reporting the results.

In discussing the report, The Wall Street Journal notes that:

"Volunteers appreciated the thanks and the updates. And a majority felt they understood the results of their trial very well or somewhat well after reviewing the lay summaries."

Efforts like these will have a positive impact on the entire clinical research chain, from patient recruitment, reporting, and translation.


For expert medical translations of regulatory, clinical, and marketing content in 40 languages - including Spanish - request a detailed proposal from ForeignExchange Translations.

According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device. It doesn't matter if the software is integrated into the actual device or a stand-alone product. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Software validation will also be an Essential Requirement under the MDD.

As medical device companies are climbing the learning curve of software localization, many of them have been asking for help on internationalization, agile development and IEC 62304, and, of course, translation/localization. In response, the ForeignExchange team has developed an in-person training session called "Best Practices for Medical Device Software Localization".

Over the next couple of weeks, we are taking this popular seminar coast to coast. Past attendees have told us that this session really helped them develop global-ready software that will work and be effective in any language and culture.

The first event will be in Santa Clara, California on May 3rd and the second will be in Andover, Massachusetts on May 18th. Both complimentary events will be held from 8:30 until 11am with a light breakfast and time for networking.

Medical device professionals can register for the Santa Clara event here: http://info.fxtrans.com/lu20120503-best-practices-for-software-localization-ca/

Registration for the Boston event is also live; register here: http://info.fxtrans.com/lu20120518-best-practices-for-software-localization-boston We are excited to see our readers in Boston and Santa Clara!

For more on software localization and internationalization for medical devices, take a look at the following articles:

• Designing medical device software for MDD compliance
• Medical software ready to take on the world
• A conversation about software localization

ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.

The European Medicines Agency (EMA) is planning for the implementation of new pharmacovigilance legislation in July this year. The new rules (Directive 2010/84/EU [PDF link] and Regulation (EU) No. 1235/2010 [PDF link]) amend existing legislation and was adopted back in December 2010.

The main goal of the legislation is to strengthen the EU-wide system for monitoring the safety and benefit-risk balance of medicines. Four key areas will be targeted in the legislation (from PharmTech.com):

1. Collection of key medicines' information: Activities in this area will include strengthening procedures for submitting risk-management plans to the EMA, as well as the need for marketing-authorization holders to provide periodic safety update reports (PSURs).
2. Better analysis and understanding of data and information: Throughout 2012, EMA will be investing in new information technology systems and signal-detection tools. In particular, the agency aims to strengthen its side-effects collection system, EudraVigilance, by adding increased functionality and improving data quality.
3. Regulatory action to safeguard public health: Starting in July 2012, a new pharmacovigilance risk assessment committee will begin meeting, stepping up to monthly meetings from September 2012.
4. Communication with stakeholders: Transparency is explicit in the legislation and will lead to the online publishing of information, such as agendas from committee meetings, assessments, approvals, recommendations, and opinions, on EMA's website.

For more details, check out this helpful Q&A document [PDF link] and look for pharmacovigilance topics on FXConferences.com!

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.