Medical Translation Insight

Death may the ultimate leveler. Short of that, though, it's the Internet that's creating a level playing field. This is true in many areas but it is particularly in the area of training and education that the web has enabled professionals to learn, get certified, and obtain accreditation - all without traveling.

Our very own Rob Wagner has teamed-up with Salma Michor to write Distance Learning for Professional Development in Regulatory Affairs [PDF link] for the current issue of RAPS Focus.

Salma and Rob examine the advantages, disadvantages, and effectiveness of today's approaches to distance learning: webinars, audio conferences, and self-paced learning modules. The authors do a nice job examining geographic differences in uses and attitudes towards distance learning.

If you are a trainer, developer, or distance learner, take a look at their excellent article [PDF link].

When you are done reading Salma and Rob's article, take a look at the following related content:

• Preparing training courses for international markets
• Anytime, anywhere learning
• Learn about ForeignExchange's training translations:
  

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

Medical device and pharmaceutical companies are realizing that they require more and more "live" translation help (aka interpreting). From assistance with audits to international conferences to support for executives to legal proceedings, many drug and device companies may do not understand exactly what is needed.

What is the difference between consecutive and simultaneous interpreting?

Consecutive interpreting
In consecutive interpreting, the interpreter speaks after the source language speaker has finished speaking. The speech is divided into segments, and the interpreter sits or stands beside the speaker, listening and taking notes as he/she progresses through the message.

When the speaker pauses or finishes speaking, the interpreter then translates a portion of the message or the entire message into the target language. Many interpreters are trained in special note-taking and memory techniques that allow them to accurately render longer passages (sometimes up to six minutes).

Consecutive interpretation is best suited for situations involving a small number of people, or where a personal touch is required. Examples would be business meetings, press conferences, interviews, teleconferences, or any type of one-on-one exchange.

Simultaneous interpreting
In simultaneous interpreting, the interpreter translates the message into the target language as quickly as she can formulate it from the source language, while the source language speaker continuously speaks; the interpreter (usually sitting in a sound-proof booth) speaks into a microphone, while clearly seeing and hearing (via earphones) the speaker. The interpretation is transmitted to the target language listeners via their own sets of earphones. Two interpreters are usually needed for all simultaneous interpreting work due to the high intensity of the task.

Simultaneous interpreting is both a mentally and physically taxing task. People do not realize that an interpreter uses at least 22 complex cognitive skills while interpreting. It requires a high degree of concentration to listen, process, and convey ideas (not just words) coherently in another language, while concurrently listening to what is being said next.

Research has shown that after 25 minutes, the accuracy and completeness of simultaneous interpreters decrease sharply. The human mind cannot hold the needed level of focused concentration much longer than that.

Many simultaneous interpreters, fearful of not getting work or being perceived as unqualified, will work alone for extended periods of time. Consequently, they are not able to correct themselves, since their ability to recognize errors is also impaired. This can lead to serious and sometimes critical misinterpretations that can negatively impact others. Imagine misinterpreting a witness’ testimony in a court of law!

Other types of interpreting
Two less-known modes of interpreting are sight interpreting and summary interpreting.

Sight interpreting is "the rendering of material written in one language into spoken speech in another language" [PDF link]. These frequently occur in legal settings but can also be used when translating hand-written information, for instance, an interpreter can dictate translated information from clinical patient diaries for later transcription.

Summary interpreting is paraphrasing and condensing the speaker's statement [PDF link]. Unlike simultaneous and consecutive interpreting, this method does not provide a precise rendering of everything that is said into the target language. While summary interpreting may be inappropriate for court settings [PDF link], it is useful during quality audits and site visits.

One final point
Although some professionals offer both translation and interpreting support, they are really two different professions.

Interpreters deal with spoken words, translators with written words. Each task requires a distinct set of skills and aptitudes, and most people are better suited for one or the other. While interpreters often interpret into and from both languages, translators generally translate only into their native language.

For more interpreting-related information, take a look at the following:

• Wikipedia's Language interpretation entry contains lots of good information
• Certification for medical interpreters becomes reality
• The world's worst interpreter?

To stay educated about the language industry, subscribe to Medical Translation Insight via email or follow us on Twitter.
 

As clinical research studies are continuing to shift south and east, it's easy to accept this trend as a fait accompli. But AstraZeneca's recent experience with Brilinta shows that you don't have to be a contrarian to question this trend.

A couple of weeks ago, the U.S. Food and Drug Administration has extended the time to finish reviewing the NDA for the blood thinner. The company said FDA needed more time to study the application. However, observers quickly pointed out that the drug was significantly less effective in the U.S. than outside the U.S., and that this may be the cause for the delay.

In fact, the WSJ Health Blog's recent question Why Does AstraZeneca's Brilinta Seem to Work Only Outside the U.S.? was far from academic. As clinical trials become global in nature, sponsors need to accept the fact that positive results could come from only certain countries - or from many countries but not from an important one.

Will this dampen the enthusiasm around international clinical trials? Probably not. And in the mean time, AstraZeneca is happy that Brilinta is moving along in the regulatory approval process in Europe...

Here are three more articles on the topic:

• Global clinical research is unethical. Or a business necessity, depending on who's asked.
• Overseas clinical trials - appalling or good business?
• PatientsLikeMe making clinical research obsolete?

ForeignExchange Translations provides specialized medical translations for clinical research - from patient recruitment to ICFs to diaries - in 40+ languages. Contact us for more information.
 

JD Supra has made available a helpful terminology resource. The glossary consists of Italian legal terms that have been translated into three languages (English, French, and Spanish).

Prepared by an Italian business lawyer, the glossary has been translated according to legal criteria rather than linguistic or etymological criteria.

Where the legal concept does not exist in one or more of the three legal systems, the glossary records the term that most closely reflects the Italian legal concept and highlights the lack of full affinity between the term and the Italian legal concept by adding the symbol " * ".

Finally, where there is no close legal concept in one or more of the three legal systems (this being a remote possibility) but a consolidated translation exists in legal usage, this translation is recorded (and written in Italics).

While this glossary may be slightly less useful if a Community patent ever becomes reality, it still is a terrific resource. Check it out!

[Thanks to @L10Ntweets]

If you have five more minutes to spare, take a look at these other articles:

• Patent translations - inherently risky?
• Translation expenses take center court
• Swiss legal German-English dictionary

ForeignExchange translates patents and other IP for medical device and pharmaceutical companies into 40+ languages. Ask us for a detailed proposal on your next medical translation project.
 
 

It's been six months since our most recent social media update. Over that time, something curious has happened: Twitter subscriptions and referrals have exploded!

As of this writing, ForeignExchange has roughly 850 blog subscribers and close to 900 Twitter followers. Modest numbers, to be sure, but Twitter followers have grown threefold over the past six months and join in (relatively) large numbers - often a dozen a day.

And it's not just subscribers; we have seen the same phenomenon in our site traffic. While LinkedIn still accounts for the largest share of referrals, Twitter referrals are catching up - fast!

Could it stem from the fact that LinkedIn has recently integrated users' Twitter feeds? Or are Twitter's 140-character messages simply a better fit for our short attention span world?

I don't know what it all means and will leave the crystal-balling and pontificating to others. We are certainly not alone in experiencing Twitter's rapid growth. But it still has taken us by surprise and will cause us to to look more closely at how to use, optimize, and leverage the little birdie.


ForeignExchange is the only company that provides clients with measurable translation quality. Our METRiQ quality system provides medical device and pharmaceutical companies with known translation quality - on every assignment. Find out more!
 
 

It used to be that medical device and pharmaceutical companies weren't really paying attention to translation costs. Sure, in the absence of other decision-making tools, buyers would look at price to decide on translation suppliers. But by and large, translation budgets were too small and too fragmented to matter.

Not any more.

Nowadays, medical device companies are facing deflation and are looking to cut costs (real, hard dollars) on their 20-language labeling efforts. And pharma companies are centralizing the purchasing of translation services to gain economies of scale. Today, translation budgets matter and clients ask pointed questions are asked - "why does translation cost so much?"

Though some companies have figured out the riddle of translation budgeting, by and large, it remains a dark art. Often people will look to the past year's translation expenditure and use the same number or add a certain percentage.

With budgeting season getting underway across most pharmaceutical and device companies, now is a good time to educate yourself on how to accurately budget for translation services.

Our upcoming audio conference will help translation buyers at drug and device companies

• gain insight into the variables affecting translation costs
• understand how translation companies quote projects
• provide ideas for ways to work with suppliers to maximize efficiency and reduce costs
• give real-world advice for creating budgets and quarterly forecasts

If you are involved in budgeting for translations, put down the crystal ball and attend this informative session!


ForeignExchange Translations provides specialized medical translations for regulatory, marketing, and clinical groups at pharma and device companies. Contact us to find out more.
 
 

Are you tired of doing "everything for everybody"? Do you wish your colleagues shared your professionalism? Are you ready to make a difference?

As the leader in medical translation, ForeignExchange Translations offers unique career opportunities to bright, energetic, and passionate people. Currently, we are looking for amazing team members for the following two positions:

Strategic Account Manager (Minneapolis)
Working in a team environment, you will be supported by one of the best sales and operations teams in the industry. You will have the opportunity to:

• Manage relationships with assigned medical device client
• Carefully prepare client proposals and quotations
• Develop account management and growth strategies
• Reconcile client requirements with operational constraints to develop high-value client proposals

Business Development Director (United States)
For sales professionals with 10+ years experience creating strong client partnerships, we offer the chance to:

• Create demand, qualify and win business from new clients in your assigned territory
• Develop territory plans and key account growth strategies
• Produce and present client proposals, presentations, quotations, and status reports
• Lead various internal teams responsible for support of clients

When you are ready to make a difference, send your resume and compelling cover letter to co-careers ~at~ fxtrans.com.


Follow ForeignExchange on Twitter @fxtrans

August is vacation month in much of the northern hemisphere. That usually means we get to slow down and enjoy a more relaxing pace. Not this August though - it was one of our busiest months this year.

With regards to audio conferences, we produced several great events. The top five for the month are listed here:

1. Development Strategies for Cardiovascular Drugs
2. Human Factors Design, Testing & Risk Analysis
3. Human Factors Requirements and Usability Testing for Medical Devices
4. How to Measure Translation Quality
5. QA Oversight of Contract Manufacturers

If you would like to become an FXConferences speaker, send us a note!

Interested in other popular educational events? Take a look at the web pages for July, June, and May.


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

For medical device companies, international sales are a key driver to revenue growth. Ever since the most recent update to the Medical Device Directive broadened the definition of "medical device" to include software that is intended for diagnostic or therapeutic purposes, manufacturers have been working to bring their software localization and documentation processes to a manageable level.

For many device companies, this is no small feat. Documentation practices are frustratingly inefficient at many of these companies, and localization and documentation teams are tasked to do more with less.

In order to succeed in this challenging environment, more and more medical technology firms embrace efficient content authoring processes. "Simplified English" is one of buzz words that gets bandied about.

Whatever you call it, the approach is rooted in a philosophy that makes inherent sense to medical equipment companies: Focus on quality upstream to control process costs and time lines downstream.

If you are looking for ideas to get started or for advice on how to improve your practices, you might want to attend next week's webinar Writing and Documenting Software for the World with Agile Demands (Wednesday, September 22, 2010 at 1PM ET).

It promises to be a great event. Kent Taylor of acrolinx, Adam Asnes of Lingoport, and Mike McKenna of Yahoo! will share their views and discuss a variety of best practices around reuse of documentation, shortening text, and software internationalization. And hey - it's cost-nix!


ForeignExchange's METRiQ quality methodology provides medical device companies with measurable, known software localization quality. To learn more about our medical translation solutions, contact ForeignExchange Translations.
 
 

With every month that goes by, the medical translation projects that we handle at ForeignExchange get more and more complex. There are more formats to deal with, more files, and more language combinations. The demands of our medical device and pharmaceutical clients also dictate that the turnaround times be ever-shorter. And because most of the content we deal with is highly regulated, quality and consistency of the final deliverables cannot be compromised.

Over the years, our team has done really amazing things to help us grow. We have enabled project collaboration by stretching the capabilities of desktop tools and implementing ingenious approaches such as batch and "incremental" leveraging. But as assignments with 50, 100, or more team members become the norm, these home-grown solutions were starting to creak and break.

Enter TM server technology. Via TM server, multiple translators can easily work in parallel, and just-in-time leveraging benefits an individual linguists and the entire team.

Since the beginning of the year, we tested and piloted a number of available options for TM server technology. It has been an educational experience.

While the dominant supplier of TM server technology was busy being difficult, giving us the run-around, and even blocking our email domain, the team at Kilgray was a pure joy to work with.

As we tested Kilgray's memoQ server solution, Kilgray answered our questions promptly, supported our whims, and provided us with an all-around excellent experience.

memoQ itself highly versatile. It will allow us to work with all the file formats that we encounter on a regular basis, the user interface is simple and intuitive, and the tool is regularly upgraded with new features which aim at maximizing efficiencies in the translation process.

Starting this month, we are starting the process of implementing memoQ on select complex project with the ultimate goal of rolling it out across our entire production.

For more information on translation memories, take a look at the following articles:

• Primer: Translation memory vs. glossary
• Preparing files with untranslatable content
• 100% text repetitions: To review or not to review

ForeignExchange Translations provides specialized medical translations for regulatory, marketing, and clinical groups at pharma and device companies. Contact us to find out more.
 
 

The difference is, of course, that Helvetica is better than Arial.


Here are five resources to pay homage to the world's greatest typeface:

1. Fuck Yeah Helvetica is a blog dedicated to all things Helvetica
2. Play Helvetica vs. Arial and let Arial know that we don't need its type around here
3. Helvetica, the feature film
4. After viewing the movie, discuss the differences between Arial and Helvetica
5. Helvetica? That's that font that looks kinda like Arial, right?

At ForeignExchange Translations, we are font and language geeks. We help medical device and pharmaceutical companies look and sound just right, in any language. Contact us to find out more.
 
 

In the Boston area, we have enjoyed the best summer in years. Alas, all good things must come to an end. But before we get ready for a beautiful fall and snowy (yikes!) winter, lets enjoy the last remnants of summer.

On Medical Translation Insight, a good way to do that is to take a look at the top five articles for the month of August:

1. Refusing translations on ethical, moral, political, or religious grounds? - Just like last month, our ethics poll tops the list of articles
2. How to minimize translation errors - The first of two quality-related articles on this month's list
3. Is Google Translate accurate enough for professional use? - Written almost a year ago, this article is still highly relevant
4. Of ROI and translation - Finally a real-world case study of the ROI of translation
5. Translation quality is easy to understand, hard to do - Everybody wants good translation quality, but few know how to reliably achieve it

Looking for more great content? Take a look at our top articles for July, June, May. Happy reading and happy weekend!

This guest post is contributed by Kirk Mousley of Mousley Consulting. He welcomes your comments at his email: kirk ~at~ mousleyconsulting.com.


Pharmaceutical and Biotechnology companies are required by the FDA to perform controlled clinical trials of potential drug compounds to prove the compounds are safe for human use and are effective for treating human health issues. An important piece of executing clinical trials is the collection of data that will hopefully prove drug compounds are both safe and effective.

Traditionally, clinical trials data is collected on paper forms called Case Report Forms (CRFs). Investigator site personnel fill out these forms as the trial progresses for a given trial subject. Data entry personnel at the drug company running the trial (called the study sponsor) then transcribe the written data into electronic form in a clinical trials database.

In detail, the paper based collection process is made up of, at minimum, the following steps:

1. Delivery of study materials - CRFs, Investigator Brochure, and "potential drug compound" to the site(s).
2. The investigator(s) will enroll patients into the trial and get necessary enrollment or randomization information from the study sponsor.
3. The investigator will have a member of the site staff fill out the CRFs from the patient charts, lab records, and other pertinent medical records. Patient diaries are likewise filled in by the patient at the designated time(s).
4. The Clinical Research Assistant (Study Monitor and CRA) goes to the site to review the CRF, add notes to the CRFs, and then brings them back to the sponsor, or sends them to the sponsor.
5. Once the sponsor receives the completed CRFs, the data is then entered into a clinical data entry system.
6. Once the data are in electronic form, a number of checks are run on the data to verify its correctness.
7. If data are found that the sponsor believes is incorrect, such as a drug administration date being before the consent date, a form is sent to the investigator asking for clarification.
8. The investigator enters the correction for the data on the data clarification form (DCF).
9. Upon receiving a completed form from the investigator, the data coordinator corrects the data.
10. Steps 6 to 9 are repeated until all checks are passed to sponsor's or QA authority's satisfaction.

The traditional paper based data collection process is known for its inefficiencies. The two biggest time lags are the time needed to get the CRFs to the sponsor, and the time needed to get data correction clarifications to the sponsor.

Electronic Data Capture attempts to address these inefficiencies by moving the entry of data to the source of the data, and performing data verification (data edit-checks) at the entry site. Moving the data entry to the source of the data accelerates steps 3 through 5. Performing data verification at the site accelerates steps 6 through 9. However, the major impact is removing the loop in step 10.

EDC can be implemented in a number of different ways. Perhaps the most promising way is to make use of the Internet. The sponsor company can deploy a browser-based data entry application. As long as the investigator site has Internet access and a web browser, investigator site personnel can use this application to enter the data for the clinical trial. The site user should be able to launch the data entry application, log into the application using his/her username and password, and enter the data. Data verification programs will flag errant data as it is being entered, allowing for data to be corrected on the spot.

There are other options to implementing EDC that are possible. EDC can also be implemented using Citrix Metaframe, a software application that allows remote users to be connected to a server over the Internet in a manner similar to a web browser. There are also hybrid systems that allow users to enter data locally on their own PC, and then synchronize the data on a periodic basis by connecting to the Internet and running the synchronization software.

No matter how EDC is implemented, the basic process changes remain the same. Responsibility for data entry moves to the investigator sites, and traditional paper based processes must be modified to accommodate this movement.

Fundamentally and overall, the language translation and globalization requirements are the same for paper and EDC-based entry systems. CRFs can be translated to the native language of the investigator site(s) and likewise, EDC data consistency error messages (and/or DCFs) can also be translated to the site’s preferred language. The main difference is that EDC will require the translations to be presented in electronic format, either in the EDC screens, or in the error messages presented by the EDC application.

There could be a couple places where translated EDC entry systems might prove beneficial compared to paper-based CRF-based entry systems. One might expect that native speakers of any given language would do a better job of data entry in their preferred language compared to a non-native speaker who does not know and understand the words they are entering. Furthermore, EDC might ease the burden of any needed translation of entered data to the language of choice for the study sponsor (and/or regulatory submission agency) by spreading out the data-centric translation chores over the life of the study, as opposed to one or more times of intense efforts that would be required once the paper CRFs were collected and data entered.


ForeignExchange provides specialized medical translations for clinical trial applications, protocols, informed consents, patient diaries, INDs, patient recruitment, and health economic research - in Chinese and dozens of other languages. Contact us for more information about our clinical translation services.
 
 

As we mentioned before, you can't best-guess medical translation. You either know the subject matter or you don't.

Depending on what type of medical translation you handle, it can be challenging to master so many different subjects. Thanks to the web, that is getting easier, at least in the areas of biology, chemistry, organic chemistry, and physics.

The Khan Academy, which has the stated aim to "empower everyone, everywhere with a free, world-class education" through videos, has a nice selection of videos in those four fields. Take a look and brush up on your know-how!

[Tip of the hat to The New York Times' DealBook]


ForeignExchange Translations provides specialized medical translation services to biopharma and medical equipment companies.
 
 

As we go into Labor Day weekend in the United States and Canada (Labour Day), we thought it would be interesting to look at the origins of this symbolic end-of-summer holiday.

Labor Day has its roots in the workers' movement of the late 1800s and is celebrated on May 1st in many countries around the world. Sometimes called International Workers' Day or May Day, the significance of this date relates to the "Haymarket Massacre" on that day in Chicago in 1886. Laborers were protesting the long working hours to which they were subjected and were pushing for an eight-hour workday, leaving eight hours for leisure and eight more for sleeping. A scuffle with police resulted in tragedy and the date lived on in infamy.

Ironically, it was the U.S. that moved the date of its Labor Day commemoration to the first Monday in September to dissociate from the riots of 1886. Moving it to the end of summer also distanced the U.S. from the May Day celebrations of European countries and, during the Cold War, away from the Soviet Union and its annual lavish celebration of Communism. May Day remains a national workers' holiday in more than 80 countries around the world.

A bit of trivia: the edict to not wear white after Labor Day comes from the tradition in the U.S. Navy to switch from their white uniforms to blue ones after Labor Day.

If you're in the U.S. and Canada, enjoy the long weekend, and your last chance to wear white.

ForeignExchange's U.S. offices will be closed on Monday, September 6th.


Take a look at ForeignExchange's desktop publishing and multimedia services for medical device and pharmaceutical companies and request a detailed proposal for your next multilingual desktop publishing project.
 
 

We ran across an interesting article the other day about creating translation-ready software help. The author, Lorraine Kupka of NorthCoast Writers, Inc., wrote the article for the WritersUA.com blog. In it, Ms. Kupka lists eleven best practices for creating localization-friendly software help content.

Many of the best practices the article lists also apply nicely to other types of technical documentation, such as manuals, IFUs, clinical reports, and regulatory dossiers. Here are the best practices:

1. Follow Best Practices for Technical Writing
2. Consider How the Text Will Appear After Translation
3. Use CSS Styles Instead of Local Formatting
4. Use Naming Conventions
5. Document Conventions and Processes in a Style Guide
6. Simplify Conditioned Text
7. Don't Embed Text in Images
8. Consider Whether to Translate Sample Data Used in Screen Shots
9. Remove Extraneous Project Files (Targets, Topics, TOCs, Etc.)
10. Identify Topic Content that Must Match the User Interface
11. Structure Content to Match the TOC Hierarchy

For details on these steps and some fine examples and scenarios, check out Ms. Kupka's article on the WritersUA.com blog.


ForeignExchange localizes software applications and training programs for medical device and pharmaceutical companies. For specialized medical software localization services, contact us today!
 
 

We don't see much call for Latin translations these days. But rumors of that language's death have been greatly exaggerated. This year, the U.S. Catholic church is giving translators and publishers a lot of work as they set out to revise the existing English translations of the original Latin Catholic Missal. The current Missal, which guides Catholics through the prayers in a Mass, is based on translations done in the 1960s. Sentiments in the Church are that those translations were rushed and not accurate to the tone originally intended.

But the move to re-translate is not without debate. Some bishops and church experts feel that the new translation is too literal and the altered wording doesn't reflect the teaching of Jesus, who spoke in the "tongue of the common person" which the existing translation is thought to do. Regardless, the new translation will have a wide impact, affecting every Catholic in the U.S., many of whom have gotten accustomed to reciting prayer responses from rote memory. For example, instead of responding with, "And also with you," to the priest's, "May the Lord be with you," worshipers will say, "And with your spirit," according to the new translation.

Aside from worshipers, and the diocese who must educate them, the new translations are a challenge to publishers of the Missals used in churches as well as the linguists who are carefully poring over the Latin phrasing, teasing out its most accurate English meaning. The deadline for the new Missal is the first Sunday of Advent next year, which falls on November 27th, 2011. To all affected, we say, "may God have mercy on your souls."