Medical Translation Insight

ForeignExchange has a strong history in the translation of Japanese regulatory and clinical documentation. We have a strong team of qualified native-speaking Japanese linguists and a technical services staff that is experienced in the nuances of PAL-compliant documentation for both the medical device and pharmaceutical industries. We have not only expertly translated content for our clients but have also partnered with them on upstream process efficiencies to address the unique logistical, technical and cultural challenges faced when working within the framework of PMDA and with Japanese Marketing Authorization Holders. You can download a white paper that discusses some of these process improvements.

In addition to our work with clients, ForeignExchange was the only translation provider selected by the Regulatory Affairs Professional Society to translate its authoritative book, “Fundamentals of Japanese Regulatory Affairs” from Japanese into English. The book is the industry's definitive guide for navigating product approvals in Japan as well as a textbook for regulatory professionals seeking certification credits.

ForeignExchange's expertise is not only seen in our translation work but also in the various conferences in which we've been invited to speak on Japan regulatory translations and articles our staff has published in respected industry trade journals such as RAPS Focus and Multilingual. To find out more about ForeignExchange's Japanese capabilities, check out our Website.


Find out more about ForeignExchange's specialized Japanese translation services for medical device and pharmaceutical companies.
 

In medical translations, the ability to track changes is a key component of delivering quality to clients. And it's not just about the quality per se; for regulatory submissions or some clinic trial work, all changes have to be documented and approved, which means that change tracking is an everyday task for many medical translators, editors, and project managers.

ChangeTracker, a new tool for professional translators and editors simplifies and speeds up this process. ChangeTracker is available free of charge from www.change-tracker.com.

The software is very easy to use: download the tool, start it, drag two bilingual files (e.g., a original translation and corresponding edited file) into the corresponding fields, align the names, and run it. In our use, this process has proven to be much faster than using other tools, such as ApSic Comparator.

As of version 1.0, ChangeTracker compares bilingual documents in many popular formats:

• Trados (TTX, SDLXLIFF)
• MemoQ (XLIFF)
• Idiom, Translation Workspace (XLZ)
• Oscar (TMX)
• Wordfast (TXML)Microsoft Helium (HE)
• Microsoft Word (DOC, DOCX, RTF)

Whether you want to get improve final quality, document changes, or improve consistency, ChangeTracker can be a great addition to your toolkit!

[Source: About Translation via Donna Parrish]

For more on this topic, take a look at:

• Automating QA in translation
• Man vs. machine in proofreading
• Tools: QA Distiller

After a post like this, how can you NOT subscribe to Medical Translation Insight via email or RSS?!?
 

For the eleventh year in a row, clients of ForeignExchange Translations say they are very satisfied with the quality and service they have received, and an astonishing 96% say they would gladly recommend ForeignExchange to other companies looking for a translation and localization provider.

Since the year 2000, ForeignExchange has conducted a comprehensive annual survey of its clients, to assist in determining the focus of its ongoing service improvement efforts.

The 2011 survey results are now in, with an overall satisfaction rating of 5.27 out of 6. When comparing ForeignExchange to other translation and localization providers with whom they have worked, clients stated their belief that ForeignExchange is doing a better job in terms of quality, price, customer service and technical knowledge.

The 2011 survey was sent to 408 clients who signed off on translation projects within the calendar year. 91 surveys were completed, for a response rate of 22%. You can download the summary report of the 2011 survey here.


ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known software localization quality. To learn more, contact ForeignExchange Translations.
 
 

We've got some great educational offerings in the next few weeks.

Translations 101
Translation is an arcane discipline, where state-of-the-art technology comes together with a very human process. Done well, medical translations can save lives by getting products to market faster with the vital information needed for safe, correct use. But it can be expensive and time-consuming and translation quality can be difficult to measure. Many people don’t know how it works and myths and misconceptions abound.
On February 29th, we will be hosting a complimentary Learning Unplugged seminar on “Translation 101” in the Boston area.  It will cover how translation works – the technology, the people and the process. It will explain what Translation Memory technology is and how it augments the human function. We’ll cover what makes a good medical translator, why editing is important and the nuances and pitfalls of localized document design and layout. Attendees will go away with not only a better understanding of how the translation process works but also with actionable takeaways that can help improve quality, shorten timelines and save money when working with their translation providers.

The two-hour complimentary seminar will be held on February 29th. Location details remain to be confirmed but if you’re interested in attending, contact education@fxtrans.com to get more information or get added to the attendee list.

Plain Language Authoring
The Plain Writing Act of 2010 is the latest government effort to make complicated regulations easier to read and understand. "Plain language" refers to a method of authoring documentation in a straightforward, sensible, engaging and culturally appropriate manner. It makes the complicated easier to grasp. It tells readers what they need to know and nothing else. When done correctly, it ensures understanding and compliance and improves patient safety – and now it's the law! What plain language is not, is the "dumbing down" of information.

Kristina E. Anderson of EasyRead Writing LLC, will be presenting on this topic on February 1st and you can register to listen in here:
http://www.fxconferences.com/Improving-Compliance-and-Patient-Safety-with-Plain-Language-Authoring-P803.aspx

EMA Submission Compliance
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided. Our own Anabel Perez will be presenting on this topic on February 21st. Register here:
http://www.fxconferences.com/Meeting-the-Linguistic-Requirements-for-EMA-Submissions-P814.aspx


ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known software localization quality. To learn more, contact ForeignExchange Translations.
 
 

Anabel Pérez is one of our Senior Project Managers here at ForeignExchange Translations. She has been involved in the medical localization field since 2004 in a variety of roles from freelance translator to in-house proofreader and localization project manager.

Over this period, Anabel has gathered a lot of know-how around EMA submissions. She understands that translating product information documents in preparation for an EMA submission can be a frustrating, complex, and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.

In her presentation Meeting the Linguistic Requirements for EMA Submissions, looks at the the pain points encountered when translating for an EMA submission and proposes solutions, innovations, and best practices that will allow client and medical translation supplier to work together collaboratively to meet all the EMA requirements.

Anabel's presentation covers:

• Project start-up – start right to finish well (communication protocol, scheduling, linguistic strategy)
• QRD requirements (linguistic and formatting)
• Tools for QA (QRDetect™)
• Pain points: affiliate & member state review, timetables, change management
• Post-mortem process: learning and improving

Register or download the recording to learn how to take the linguistic pain out of EMA submissions!

For related information, take a look at the following:

• Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
• QRD templates are imperfect, getting better
• QRD compliance just got easier thanks to QRDetect
• Requirements for readability testing of PILs

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

The Saudi Food & Drug Authority (SFDA) is still relatively young - it was only established in 2003. That's not stopping the newish agency from embracing eCTD though.

SFDA published some information regarding their roadmap towards electronic submission. The timeline looks like this:

• Starting from December 20, 2011, NeeS submissions for human medicinal product dossiers will be accepted by the SFDA according to the Guidance for Submission [PDF link] which has been released in version 3 in December 2011.
• As of September 01, 2012, the NeeS format will be the mandatory submission format for the SFDA. No other formats will be accepted.
• Starting on January 05, 2013, the eCTD will be accepted, which will become the preferred submission format one year later (starting on January 04, 2014).
• Finally, starting from January 03, 2015, only eCTD will be accepted.

The above information is adapted from Exalon and SFDA's web site.

You might also be interested in the following articles:

• What happened to the "global" eCTD?
• eCTD translation
• Working with numbers in Arabic translations

ForeignExchange Translations provides specialized translation services for regulatory submissions by pharmaceutical and medical device companies. Contact us to learn more.
 

2012 has started and medical translation clients and professionals are slowly returning to work after taking time off over the Holidays. This is a good time to review the most popular audio conferences and webinars from the past year.

Our team produced roughly 120 events - 2 to 3 every week of the year - that attracted close to 5,000 attendees. Many of our events were in the areas of clinical research, quality management, regulatory affairs, and, of course, translation.

This diversity is also reflected in our list of the five best sellers for 2011:

1. Sample Size for Design Verification and Validation
2. Off-label Promotion – What FDA Looks For & What You Need to Know
3. Best Practices for Writing Safety Narratives
4. Advanced Human Factors Engineering
5. eLabeling Medical Devices for the EU Market

If you have a suggestion for a topic you would to present, be sure to send us a note!


For a detailed proposal on your next clinical, regulatory, or marketing medical translation assignment, contact ForeignExchange Translations.
 

What is Dunglish, you ask?

A) The combination of the words Dutch and English.

B) The language produced when these two languages collide.

C) A blog by Natasha Cloutier.

Sure, the web is full of Chinglish examples but there is just something uniquely funny about the language produced by Dutch speakers who have been abroad too long, and by English speakers whose English is going Dutch.

Maybe it's because one assumes that they should know better? Chinese, after all, is a totally different language, and most of its speakers don't grow up with English.

Not so in Holland though. Or at least that's the stereotype. Doesn't everybody in Holland speak perfect English?

With the help of Dunglish (as well as this less-than-perfect English web site for a Dutch language school), it's becoming clearer that, like most stereotypes, this one may be just a wee bit off the mark...

After you've subscribed to Dunglish, take a look at more funnies at Übersetzungsfehler and Mox's Blog.


You can follow ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 

A belated Happy New Year to all of our readers!

2011 was a terrific year for Medical Translation Insight. We were able to report on important issues impacting medical device and pharmaceutical companies, suppliers, and translators. As a result, our readership has more than doubled. We appreciate everybody's interest and support!

December was a good example of our efforts. We were able to generate good discussions on a number of topics. Here are the most-read articles from the past month:

1. Readability is important (and difficult) when translating informed consent forms - Clinical research practitioners as well as medical translators feel strongly about this issue
2. WHO style guide good resource for medical translators - A valuable resource from WHO for medical translators
3. Measuring translators' performance - What to measure: translators' performance or the final product?
4. Why does my Microsoft Word document display differently on different computers? - A real-world question with real-world answers and tips
5. Psst - over here! I'll sell you translations for $5! - A new "hub for all kinds of mobile workers buying and selling small services" contains low-priced translation offers

Follow ForeignExchange on Facebook, Twitter, YouTube, and LinkedIn.
 
 

The new frontier in sign language? Gloves.

As patients with disabilities get more more and more attention, one area of development that's picking up are so-called "sign language gloves". These electronic devices converts the complex motions of a sign language into written or spoken words.

One of the latest entries into this field is the "Texting Glove" invented by Google developers Oleg Imanilov, Tomer Daniel and Zvika Markfeld. It is designed with a Lilypad Arduino, flex sensors on the fingers, an accelerometer, a gyroscope and an ADK Board (Android Open Accessory Development Kit). The data is communicated to an Android phone which uses custom software to translate the sign language into text messages.

The Texting Glove is by no means the only contender in this still-developing market niche.

In 2008, students at Carnegie Mellon University developed HandTalk as part of a class research project. And as early as 10 years ago, a high school senior built a prototype of the sign language translator using a leather golf glove with 10 sensors, a small circuit board containing a micro controller, analog-to-digital converter, and a radio-frequency transmitter.

Maybe third time is a charm when it comes to creating an instant, mutually understandable communication link between hearing people and the hearing-impaired world?

[Kudos to Medgadget]

For more on sign language, take a look at the following two articles:

• Medical terminology in ASL
• MobileASL allows deaf people to use sign language when making phone calls

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