Medical Translation Insight

Last week, an EC-backed study called Size of the language industry in the EU was published. This hefty study (the PDF is 426 pages long) is heralded as "the first to analyse the size of the language industry EU-wide, covers translation, interpreting, localising and globalising, subtitling and dubbing, language technology tools, multilingual conference organisation and language teaching".

The report contains some eye-catching data, chief among them the claim that Europe's language industry is worth €8.4bn and is set to grow by 10% annually.

Unfortunately, the report's credibility is undermined by some obvious problems, including:

• On a couple of occasions, the report makes unsubstantiated claims about unfair competition in the translation business. This is not to argue that unfair competition doesn't exist but such an important claim warrants an explanation or reference.
• ISO 9001 is mistakenly referred to as "ISO 2001" - several times.
• The report contains contradictory conclusions: The authors remark on the low barriers to entry to our industry. This is accurate but doesn't jibe with the report's statement that "the currently fragmented nature of the language industry will continue to consolidate into larger commercial entities". M&A activity may continue but until some company puts up defensible barriers to entry, acquisitions are unlikely to result in consolidation.
• Finally, the report's non-standard font encoding greatly complicates its use.

Nonetheless, the report does offer insight into the makeup of the European translation market. It also highlights some of the challenges faced by translation service providers:

"Entry barriers to the field of translation and interpreting are low. The main consequence is increasingly fierce and sometimes unfair competition, as well as a decrease in prices combined with a decline in quality levels. The new EN15038 certification designed to counteract this trend ... appears to require amendments."

We have already seen this "decrease in prices combined with a decline in quality levels" in action: A tongue-in-cheek comment in the proz.com forum wonders weather or not "...0.00 per word is a fair price for a Portuguese-English translation done by a native Italian residing in India."

On a more serious note, Jose Henrique Lamensdorf's concept of an X market for translation addresses the same question: What is the price/quality ratio of a given translation?

For medical device and pharmaceutical buyers of translation services, this changing landscape requires them to define (really define) their quality expectations. Simply requesting "good" or "perfect" quality will, sooner rather than later, lead to unacceptable quality. Similarly, translation service providers will finally need to define the quality and the value that they provide.

And all of this is good news for clients and providers alike. More effective segmentation around quality and price will make translation service providers more effective and help clients find appropriate translation suppliers.


ForeignExchange Translations saves lives. We provide biopharma and medical equipment companies with specialized medical translation services with measurable quality.
 
 

The good folks at ABBYY have developed a whole bunch of tools that have simplified the lives of translation clients and practitioners. A lot of us are familiar with ABBYY FineReader. We have previously discussed how tools like FineReader streamline the translation of scanned PDFs in dossiers and clinical research studies.

Now ABBYY has entered the increasingly crowded space for tools that create translation memories. Its ABBYY Aligner tool is based on ABBYY's existing linguistic technology and uses lexical data to perform its alignment duties.

ABBYY's press release offers up the following details:

The application aligns texts in 10 popular European languages (English, German, French, Italian, Polish, Portuguese, Russian, Spanish, Turkish, and Ukrainian) with support for 90 translation directions. The resulting texts can be saved either in RTF or TMX format which are international standards supported by virtually any CAT tools. ABBYY Aligner opens files in TXT, RTF, PDF, HTML and documents created in popular Microsoft® Office applications (DOC, DOCX, PPT, PPTX, PPS, PPSX, XLS and XLSX).

Have you taken the leap and purchased ABBYY Aligner? How does it compare to other tools?

[Tip of the hat to Jost Zetzsche's Tool Kit.]


For further reading, check out the following:

• What you need to know about translation memories provides an overview of translation memories, text alignment, and some of the pros and cons in the technology.
• We previously looked at OCR software, including ABBYY FineReader, here and here.
• L10Nworks is a repository of translation and localization freeware/shareware tools.

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

Our blog hasn't even been open for a whole year yet but already we're receiving a steady flow of pitches regarding products, services, and guest posts. Thank you - we are flattered!

When it's appropriate, this kind of PR is terrific all around - it provides a fresh perspective to our readers as well as exposure for the writers. Here are a couple of recent guest posts on eCTD formats and a linguist's perspective on medical translation.

The problem is that most of the pitches aren't appropriate for our site and our readers.

To help with this and make it easier for PR folks, entrepreneurs, and prospective authors, here are five tips for submitting your ideas to Medical Translation Insight:

1. Make sure it's relevant
Nothing against language courses, medical schools, or articles about the latest clinical indication received by drug X but before pitching us, please make sure that your idea is likely to be of interest to our readers.

Consider that most of our posts are geared at professional linguists and staff at pharmaceutical and medical device companies. Posts generally touch on at least two of the following: translation, regulations, technology.

If your pitch doesn't fit, think about whether or not you can make it fit.

2. Listen before you speak
To help you with #1 above, invest the time to read our blog and pay attention to comments, retweets, and trackbacks. What kinds of topics get lots of attention? Which ones don't?

3. Hang out a bit
Since you have taken the time to subscribe to Medical Translation Insight, start participating in the conversation, get on our radar, and make relevant comments. That will make it easier to understand what the blog is about and will give us a sense that have have something of value to contribute.

4. Make it easy
Once you have built some credibility and recognition, don't ruin all your hard work by sending a press release. Here's a solid plan:

• send a very brief note pointing out a story idea that would be a good fit for the blog's reader (50 words – "here is a great idea") and ask if we would like further details
respond with details but don't write the post – instead, give bullet points and links
• add another reason why it's a timely/exclusive/trendy story idea

5. Gift wrap your idea
Hey, we like exposure too! So how about outlining how you might promote the published article in your blog, on Twitter, on your web site, in your primary association's newsletter, etc.?

We love your ideas and suggestions - keep them coming! And if you use these guidelines, we'll all benefit from timely and interesting content.


[The above tips were loosely adapted from John Jantsch's 5 Tips for Getting More Exposure from Bloggers, Tweeters and Fans.]


ForeignExchange is on Twitter - follow us at @fxtrans!
 
 

Gobble, gobble - today is Thanksgiving in the U.S., a time to spend with family and give thanks.

If you want to express gratitude and at the same time impress your neighbors, family, and friends with your language skills, head over to Jennfier Runner's language page. There, she maintains hundreds of language versions of "thank you".

Want to go a step or two further? Jennifer also shows you how to say hello, goodbye, and many more things.

And while we are on the topic of giving thanks: Thank you very much for reading our daily updates! As we close out the first year at Medical Translation Insight, we are humbled by and grateful for your support.

[Picked up from Kirti Vashee's Twitter feed]


Follow us on Twitter at @fxtrans.
 
 

Earlier this year, Google Translate single-handedly improved the reputation and usability of automated online translations. Until its release, online machine translation solutions (especially of the free kind) were marginally useful at best.

Google Translate has changed that, largely by using a statistical approach to machine translation and by allowing users to help the system learn adaptively.



And with a service that allows millions of amateur translators to pour their translations into an open translation memory, Google hopes to change professional translation in the way that flickr and istockphoto have changed commercial photography. Online machine translation has the power to revolutionize communication by eliminating language barriers, bridging the gap between cultures, providing services and information to speakers of minority languages, and transforming global e-commerce by allowing even the smallest online vendor to serve the international market.

But will Google Translate really have that far-reaching an impact?

Translation practitioners and clients/users of machine translation tools see two main challenges that must be overcome before a system like Google Translate can hit the big time:

1. Quality of translated text needs to improve
2. Copyright law needs to be amended

Quality
Just how good is the output from Google Translate? Well, it depends.

Sometimes, it stinks. Other times it is quite effective. Some people even claim that there are instances that Google's language translator can provide a translation as if a human translates it. And occasionally it produces music.

A lot of it clearly depends on the subject matter and language pair being used. For instance, a review of the system's French abilities gave it a middling grade. The reviewer thought "that it's ok to get the gist of it, but the grammar isn't great and there are words missing here and there, also French words appear instead of English words in the translation." Not exactly a ringing endorsement.

Interestingly, we have had some of our medical device clients use Google Translate as part of their in-country review process. One medical device manufacturer uses Google Translate to determine the completeness of a translation. "Often translations come up in perfect English syntax", the client notes. "When translations come up with very questionable meanings I at least like to have them checked."

While the resulting back translation quality is rough, the client feels that the quality is good enough for the system to provide a back translation that is used as a QA tool.

Copyright
Machine translation will create massive copyright infringement on an unprecedented global scale - or that is how Erik Ketzan views the situation, as voiced in his 2006 research paper, Rebuilding Babel: Copyright and the Future of Machine Translation Online.

Why? In America, at least, copyright law considers a translation a derivative work. That means that translators must obtain permission from the copyright or derivative right holder of the source language text.

It's one thing to translate a text that has been assigned from medical device company to translation company to freelance translator. Money changes changes hand and deliverables are delivered.

But what happens when a Google Translate gets used? First off, the system's translation memory contains content from other companies/users. While they have given their permission by agreeing to Google's Terms of Service, the clients in our hypothetical example might not want these translations used in their work.

Second, when a linguist helps improve already existing texts, these translations now are part of Google Translate's corpus - even though the end-client did not give permission for this. No wonder that some translators view Google Translate as the new evil empire.

This has "ticking time bomb" written all over it...

Want to know more? Here is some additional reading on machine translation:

• Primer: Machine translation vs. translation memory
• "Employee-sourcing" the new crowdsourcing?
• Congrats to the office of the tape recorder!
• Assessing quality in machine translation

Are you on Twitter? Follow ForeignExchange Translations at @fxtrans!
 
 

Medical device consulting firm Emergo Group released results from its second annual survey of medical device manufacturers, distributors, and industry service providers. The survey provides a snapshot of the industry and is structured as a short set of questions.

Asked "Have you noticed a change in international sales/orders for your company during the last three months?", more than a third of respondents indicated that sales/orders have increased.

When asked "In 2010, does your company plan to enter any new international markets for the first time?", nearly 64% of companies that export said they plan to enter at least one new international market.

Depending on company size, the top targets vary a bit:

< 50: Europe, Canada
50-500: Brazil, China, Japan
500+: India, China, Japan, Russia

Overall though, Brazil and China top the list of new markets that device manufacturers want to enter. As these countries continue on their growth spurts, health care spending is accelerating. For instance, spending on in-vitro diagnostic devices is likely to double by 2015.

It looks like it will be a busy 2010...

[Thanks to Medical Product Outsourcing for the tip!]


ForeignExchange Translations provides medical device companies with specialized Portuguese and Chinese translations. Contact us to learn more.
 
 

Yesterday's York Times included an article on how IBM is improving on crowdsourced translations by using its global base of employees.

In an effort to improve its internal machine translation tool, n.Fluent, IBM is soliciting help from humans:

Over a two-week period last month, the company issued a “worldwide translation challenge” to its employees, using a points-based system to award the biggest contributors prizes that were converted to charitable donations. About 6,000 I.B.M. employees made improvements in 11 languages to more than two million words of text translated by n.Fluent.

On the one hand it is interesting to see developers improve the ways in which machine-translation tools are built and assessed. On the other hand, "employee-sourcing" of translations is like déjà vu all over again.

Drug and device companies have long used staff resources to translate clinical research materials, regulatory submissions, and marketing collateral. And which medical device company isn't cursing the slow and inconsistent output they receive from their employee-sourced in-country reviews?

Most pharmaceutical and medical device companies have gone the other way, aggressively outsourcing translations and translation management. So, is "employee-sourcing" of translations unique to IBM or the beginning of the pendulum swinging back?

We have posted extensively on crowsourcing. Here is a selection of articles for further reading:

• Crowdsourcing to accelerate drug development
• The "X" market for translations
• Central update of TMs by translators
• Will crowdsourcing change the translation business?

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

Seems like everywhere you turn these days, there are people fretting about how to address the business process and cultural challenges of "going global".

It's no surprise that there is a good bit of hype involved. But smaller companies are also coming to the realization that going global isn't as easy as it seems.

Before you worry about software internationalization, there are business partnership to be made to cover fulfillment, logistics, financial clearance/payments systems, legal and tax issues, etc. Pre- and post-sales service must be local or at least designed locally.

A couple of years ago, Bank of Scotland shook up the Irish mortgage market very successfully, from a call center in Scotland. However, the business was designed in Ireland, with a thorough investigation of the local issues. They then went on to open the Netherlands market - this time online. Again, huge success, again firmly founded in local partnerships and implementation.

Content is still King. Yahoo! is genius at providing regionally relevant content - they have hundreds of local content partnerships. Similarly, MTV's European success only started when they addressed local needs, by adding local programming feeds and advertising windows. And McDonald's makes sure they satisfy local tastes by giving you mayonnaise with your fries in the Netherlands and Curry Potato Pie in Hong Kong.

Once you've worked through all the business stuff (and there's plenty more here - brand and marketing for a start), you are ready to start designing the systems. At its most simple, think of globalized system design as having two layers:

• internationalization - coping with things that have to be done, or supported (e.g., character sets) and
• localization - local issues supported by the internationalized layer (e.g., use of color).

Some more fundamental internationalization challenges are addressed by technology: plenty of packages address language, dynamic page build, personalization, content management, and so on. Hosting must be regional, and mirrored, to ensure respectable download times.

And finally there is naming itself. Logigo.com (a now-defunct e-logistics firm) had their company name checked for worldwide cultural acceptance. The report concluded: "We have looked at this from the Chinese, Malay ... and as a long shot we think that perhaps the pronunciation of the words could be close to a local expression Lau-chee-ko which roughly translated in a Chinese dialect used locally means 'dirty old man.'"

The lesson? Get local, expert assistance when you internationalize your business.


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

Schering-Plough was caught red-handed [PDF link] attempting to hide cash and not pay tax on it.

One of the interesting aspects of the case is that the company argued in New Jersey federal court that it was innocent because documentation from its attempt to hide $839 million in cash from the IRS was written in Dutch.

According to BNET Pharma, Schering-Plough tried to persuade the judge that some of these documents should be dismissed simply because they are in a language other than English:

Schering-Plough urges the Court not to give much or any weight to these documents. First, it claims that because the internal credit proposal generated by ABN was largely written in Dutch and the author was not identified, the Court should discount its probative value.

While the court ultimately decided against Schering-Plough, it will be interesting to see if the "but it's written in Dutch!" defense will join other excuses like "The internet was down" and "I was attacked by a raccoon and had to stop by the hospital to make sure it wasn't rabid".


ForeignExchange Translations provides specialized translation services to drug and device companies - in Dutch and 35 other languages!
 
 

Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design.

Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

But hurry! If you purchase Considering Human Factors in Designing Medical Device Trials by November 26, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

Many medical device companies treat Japan different from other markets.

On one hand, streamlining Japanese translation processes for effective regulatory submissions is a huge priority. On the other hand, U.S.-based companies generally rely on their Japanese affiliates to handle the creation of regulatory documentation and don't know exactly what was submitted.

RAPS Focus [login required] features an article written by ForeignExchange's Jason Heaton that provides a real-world example of how companies tackle this situation.

Using the experiences of a U.S.-based medical device company, the case study details how the manufacturer transitioned from an "FDA first, then throw it over the fence" model to a Japan-centric submission process. The challenges faced by the device manufacturer were predictable: struggles over who did what, clarifying (and agreeing on) tasks and responsibilities, supplying additional training, and version control.

While the transition wasn't always easy it did provide huge paybacks. The greatest benefits to the company's business were the consistency of submissions as well as the ease with which future submissions could be processed. And, maybe as importantly, was the new-found working relationship between U.S. headquarters and the Japanese affiliate.


For more information on this topic, listen to Effective Translation Process for Japan Regulatory Submissions.


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

It seems like a day can't go buy when we don't hear a drug or device client tell us that their mandate is to "do more with less".

"Less" usually refers to resources - dollars and people. "More" often means faster turnaround times with ever-growing language sets.

Unfortunately, when it comes to language translations, few managers explain what is meant by this. "Doing more with less" is really just management speak for "don't complain about your workload - you should be happy that you still have a job".

Translation managers at pharmaceutical and medical device companies are left to their own devices to streamline and rationalize their processes. There is some low-hanging fruit, like prepping source text by eliminating untranslatable content and improving multilingual layouts, but largely, translation managers are left scratching their heads.

Luckily, help is available. Prepare to Translate: Tips for Faster, Easier, Cheaper Localization provides actionable suggestions on how medical device and biopharmaceutical companies can streamline authoring, translation, and publication efforts.

ForeignExchange's Sandra LaBrasca gives lots of real-world examples in the areas of:

• terminology glossaries
• style guides
• simplifying and consolidating source content
• internationalizing source materials
• use of translation tools

It's easy to claim that these items provide savings. But Sandra's ROI calculator proves that spending $1 on preparation saves $3 on translation management.

This session is highly recommended for any translation manager who wants to learn about state-of-the-art approaches to reduce their translation budgets while publishing more content faster.

The following resources provide additional information on how drug and device companies can streamline their translation efforts:

• Controlled authoring for faster, better, less expensive translations
• 3 steps to successful translation management
• How to assemble an effective localization kit

ForeignExchange Translations provides specialized translation services for regulatory, clinical, marketing, and training groups at drug and device companies. Ask us for a detailed proposal on your next translation assignment.
 
 

As we know, there are confounding differences between American and British English. A new book highlights these differences in a fun, comprehensive manner.

British English A to Zed provides an alphabetical listing of more than 5,500 "Briticisms" and their corresponding "Americanisms". There are sections on food names, botanical and zoological names and the whole Britain, Briton, British English elements as well. Cricket terms, connotative place-names, and connotative names of periodicals, e.g., The Daily Telegraph and Punch, get covered as well.

Language lovers everywhere will enjoy this lively read. And now I am hungry for some bangers and mash!

[Thanks to the Bulgarian Translator for the tip!]


ForeignExchange is on Twitter - follow us at @fxtrans!
 
 

"What's smaller than a breadbox, can cost $800 million or more, and takes more than eight years to research and develop?", asks a New York Times article on the streamlining of drug research.

Along with depicting the challenges, expense, and time faced by big pharma to discover and develop new drugs, the article also points to a possible solution: crowdsourcing.

We have previously talked about how crowdsourcing is all the rage in the translation business. And a distributed problem-solving and production model has been successfully used by people wanting to buy a beer company, Netflix (improving recommendation algorithms), reCAPTCHA (digitize old articles, newspapers), and, of course, Wikipedia. But big pharma? Wow!

The articles notes that:

a small group from the Sloan School of Management at M.I.T. and the Harvard Business School has created Pharmer's Market, an online prediction market that uses crowd-sourcing to forecast the likelihood of a drug's success.

The market, built on Crowdcast's Team Intelligence Platform, takes insight from "wisdom of the crowds" to leverage information from individual participants. The Pharmer's Market is currently predicting the outcomes of six breast cancer drugs with the long term goal of being a resource for the pharmaceutical community – continuing to test drugs in other areas. The results will help determine if the drugs will pass their trials, providing a better understanding of the safety and efficacy of these drugs and compounds to both professionals and the public at large.

Traditional drug development is a linear, trial-and-error method that is starting to look archaic and unsustainable. Accelerating the move from molecule to market means new thinking, new challenges but also new opportunities.

Oh, and the answer to the $800 million question? That, of course, is the fully capitalized cost to develop a new drug!


ForeignExchange Translations provides specialized medical translations for all stages of drug development - from IP to clinical research to regulatory submissions to marketing and pharmacovigilance. Contact us to find out more.
 
 

More and more pharmaceutical and device companies are starting to manage their own translation memories ("TMs"). Some of these efforts are due to the economy (bringing more functions and control in-house) and some companies are trying to deal with ever-increasing languages requirements.

One of the ways that companies are using TMs is to reduce the source text being sent for translation. For example, typical IFUs or operating manual can contain hundreds or words in contact or label information. Multiplied by 20 or more languages, these word counts add up. Drug regulatory submissions often include tens of thousands of words in non-translateable tables and figures.

While it's sometimes straightforward to indicate text that should not be translated, it quickly gets complicated. So it's great that Kevin Lossner published easy-to-use directions [PDF link] on how to prepare files that contain untranslateable text.

The basic approach is to mark not-to-be translated content as hidden text, so that it can be filtered out and does not appear in the translateable segments. Kevin's directions cover TRADOS TagEditor and Déjà Vu and can be applied to text "chunks" or text that is distributed all over the document.

As medical device and pharmaceutical companies push to "do more with less", this is the type of streamlining that can pay big dividends.


[Via Kevin's Twitter feed]


Confused by all this talk about "translation memory"? Check out the following resources:

• What you need to know about translation memories
• Translation memory vs. glossary
• Machine translation vs. translation memory

Looking for expert translation services for your pharmaceutical or medical device company? Ask us about ForeignExchange's approach to measuring translation quality.

The American Translators Association held their 50th annual conference in New York, the same location as the first conference, back in 1959. Centrally located in Times Square, the conference gave translation service providers the opportunity to mingle, network, and learn.

Attendance doubled from a year ago, to 2,300 attendees, and attracted a good bit of news coverage. Fox News' interview with ATA president Jiri Stejskal received a lot of publicity because it highlighted continued substantial growth in the translation business.

In addition to language-specific sessions such as "New Grammar for Portuguese Translators", the conference offered sessions on literary translation, financial translations, language technology as well as medical translation and interpreting.

Medical sessions focused mainly on interpreting, notably in a clinical setting. Lively discussions ensued on the difficulty of ad hoc versus professional interpreting, and the difficulty that interpreters have with different regions and variations of Spanish in Latin America.

Next year's ATA conference will take place in the Mile High city of Denver, Colorado. We hope to see you in our hometown!


Contact us to find out about ForeignExchange Translations' specialized translation services to medical device and pharmaceutical companies.

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.

The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

When translating CMC documentation, SOPs, or regulatory submissions, we regularly run into graphics that contain text to be translated. Translating text contained in images can be a slow and frustrating task.

The main problem? Source files that are not available to translators. So we're often left with manually extracting text and then recreating or editing images.

One strategy for making images easily translated would be for drug and device companies to more broadly support the open standard SVG format. Text in an SVG image can be changed without changing the rest of the image because an SVG file is itself a text file.

One of the main advantages of SVG is that the image file itself is the source file. However, SVG as a format is not widely supported by many applications. Therefore, it is often necessary to export SVG to a supported format to use it on a web page - which leaves us with the same problem of keeping and then making available to translators the source SVG files.

Despite the fact there is no "easy fix", there are some good tools out there to help with localizing. One such tool is Bjorn Austraat's Globalization Image Assistant (GIA).

The inexpensive tool (US$ 99 for a single-user license) can speed up the time needed to the task of analyzing, preparing, and QAing graphic images. Two items that would make GIA even more useful would be if it included the actual graphic in the exported reports and if it had a tie-in to OCR. GIA is definitely worth the (small) investment!

However, to address our specific needs, the ForeignExchange team ended up developing a macro that extract graphics into a Word table with the file path, graphic image, and 2 columns for entry of source/target text. To populate the source text, we use the following process:

1. Create a DOS directory listing of all graphics.
2. Turn the listing into an HTML page with links to all the graphics.
3. Print the HTML page to the Microsoft Office Document Image Writer print driver, which then opens in the MS application that allows you to OCR the text.
4. Select Tools -> Send Text to Word.

Of course, as with any OCR endeavor, the text is only as clean as the original file. Proofreading is highly recommended!

Dealing with scanned images and text is a fact of life in the medical translation space. However, GIA or homegrown solutions can help you take some of the frustration out of the process!


Contact ForeignExchange to find out more about our specialized translation services for CMC documentation, SOPs, and regulatory submissions.
 
 

Guest article:
By Kathie Clark
Director of Professional Services at GlobalSubmit and primary author of The eCTD Summit blog
Follow her eCTD news twitter at twitter.com/kathie_clark


Most people think of the electronic Common Technical Document (eCTD) as a set of PDF documents organized using an XML backbone. While this is largely true, regional authorities have issued a number of regulations and guidelines requiring different file formats - sometimes in module 1 as you might expect, but also in the "harmonised" modules 2 through 5.

EMEA's draft Guidance for Industry [PDF link] states "Other file formats such as rich text (RTF) or MS Word formats may be required in addition to the PDF requirement of the eCTD, by specific NCAs or the EMEA..." If so, these documents must be provided in a separate folder structure defined in this document, and not linked into the XML backbone.

SwissMedic also requires documents submitted in MS Word to be placed in a separate folder structure and not linked into the backbone, per their just-issued Guidance for Industry [PDF link].

More specifically, the EU M1 Specification [PDF link] spells out acceptable file formats for Module 1. EMEA accepts (and actually prefers) an XML application form, the eAF. For those relatively few companies submitting PIM, a compressed .zip or .tgz file containing all components should be linked into the backbone, not the actual XML.

EMEA's useful document QUESTIONS AND ANSWERS RELATING TO PRACTICAL AND TECHNICAL ASPECTS OFTHE IMPLEMENTATION [PDF link] also states "Modules 2.2 - 2.5 should be provided in MS Word/RTF in addition to PDF, for ease of review." SwissMedic requires these same files - plus several others in MS Word format.

Health Canada lays out special requirements in GUIDANCE FOR INDUSTRY: Preparation of Drug Submissions in the eCTD Format. The following components should be provided in both PDF and word-processed format (MS Word or Corel WordPerfect): Product Monograph, QOS, CPID, Comprehensive Summary: Bioequivalence, and responses to SDNs, Clarifaxes, NONs, and NODs. As well, Bioequivalence Data Sets must be submitted in ASCII. All of these documents should be linked into the XML backbone.

FDA's requirements for SAS transport files are well-known. However, they also require Structured Product Labeling submitted as XML in module 1 and accept define.xml in place of define.pdf for clinical studies. Draft labeling can be submitted in MS Word format.

Less well-known are some ANDA requirements (see ANDA CHECKLIST FOR CTD or eCTD FORMAT):

• QOS and amendments in PDF and MS
• Clinical Summary in PDF and MS Word

As submission pros know all too well, there are many more requirements pertaining to PDF format. Some authorities take them more seriously than others, to the extent that some health authorities won't accept PDF versions other than 1.4. Avoid complications by knowing both the ICH requirements and the specific requirements of the authority to which you're submitting.


Occasionally, Medical Translation Insight features guest articles such as this one. If you are interested in contributing a post, please contact us.
 
 

For the 9th year in a row, the entire ForeignExchange team got together in Colorado for our annual company meeting.

This year, we used a cool downtown Denver hotel as our base of operations. Now, two days after the meeting ended, the surrounding areas are said to have returned to normal.



Our company meetings are opportunities to reconnect with team members across the company, learn a little something, and have tons of fun. This year, we also introduced a panel discussion, featuring representatives from Abbott Labs and Hologic.



Meetings and activities were organized around the "Bridge to the future" theme and focused on identifying challenges and opportunities in executing ForeignExchange's strategy to grow by 25% annually over the next 10 years.



With more than 60 team members attending, the three-day get-together posed some organizational challenges. But our organizing committee did a fantastic job putting this event together. By Sunday, everybody left Denver motivated, reconnected, but just a little bit tired!

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.

This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.


Want to find other educational offerings? Visit our audio conference portal at FXConferences.com.

Let's all say it together: Translation quality is dead.

You don't have any quality unless your organization can define and measure the quality of its translations. Expressions like "quality is a given" and "we don't sacrifice on quality" are just empty words - unless and until their backed up by proof.

So why don't more organizations measure their translation quality?

Beyond the fact that many medical device and pharma clients as well as service providers don't realize that they have a problem in this area, the fact is that measuring translation quality is difficult to do.

We have previously looked at how little progress has been made across this subject area, from approaches to defining quality to implementations of available quality systems.

To the best of our knowledge, ForeignExchange's METRiQ translation quality system is the only one of its kind in the translation business. No other translation service provider can confidently tell their clients "we know that the quality of our project deliverable meets your expectations, and here is the proof".

At the most recent Medical Localization Roundtable at Localization World Silicon Valley, ForeignExchange's Sonia Monahan and Lifescan's Elizabeth Judd-Cummings gave a joint presentation on how Lifescan and ForeignExchange defined quality and implemented quality improvements to achieve Lifescan's business objectives.

Sonia is presenting additional case study materials in her audio conference Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality. Her presentation will focus on a real-world example of the methodology used to define, analyze, and measure translation quality, and how to use this known quality to achieve the client's business objectives.

Because that's the other thing about quality being dead: For drug and device companies, it's not about the translation quality itself. Measurable translation quality is a means to bigger ends - faster regulatory submissions, lower COGS, rationalized supplier pools, etc. So let's all stop talking about translation quality unless we can demonstrate how measurable quality achieves clients' business goals.


ForeignExchange Translations' medical device and pharmaceutical clients rave about our quality. Ask us for details.
 
 

EMEA's Product Information Management (PIM) system was conceived in late 2005 to to help improve the management, exchange, quality, and consistency of published product information. PIM was setup to be used either within, or outside, the eCTD.

Currently in a pilot phase where PIM submissions are only accepted subject to prior discussion with the EMEA. The goal is that by the end of 2011, all centrally authorized product information should be in PIM format.

Shoulda, coulda, woulda....

Because EMEA's Statement of Intent "strongly recommends" PIM, it is likely that pharma companies will see this as an "optional" requirement. And given the pitfalls of a PIM implementation, it is probable that only large pharma will tackle a non-madatory PIM implementation.

This hypothesis is more or less confirmed by a separate source. The eCTD Summit, looking at data from the 2009 survey "Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management" by Life Sciences Consulting Partners, noted that PIM has been adopted by only about 15% of surveyed companies - four top 20 and four mid-tier pharma companies.

Electronic submissions are coming but it sure can be slowing going!


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

Even though Ukraine is the second largest country in Europe and has a population of close to 50 million people, its domestic market for medical equipment and supplies is estimated at only US$281 million. Small, for sure, but the market is expected grow at a CAGR of 6.4% annually. Increasingly, the country is gaining the attention of medical devices companies looking for new and emerging markets.

As part of its effort to try and gain EU membership, Ukraine is busy harmonizing its regulations, including those for medical devices. Importantly, Russian certifications (such as GOST-R) carry no weight in Ukraine.

For up-to-date regulations, Bureau "Cratia" is the primary source of information. It contains extensive English resources, although the English can be a bit rough at times.

Details around medical device registrations are generally useful:

State registration of medical device is an obligatory requirement for import, sale and marketing of device in Ukraine. State registration is performed centralized in Department of regulatory policy of medicinal products and goods of healthcare area of Ministry of Health of Ukraine that is located in Kiev.

Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate of medical device is issued for 5 years and can be renewed before expiry. Application for renewal of registration should be submitted not later than 90 days before the date of the expiry of registration certificate.

Bureau "Cratia" also provides a good overviews of new device registrations, registration renewals, and the structure of registration dossiers.

For more market-specific regulatory news, take a look at:

• Brazil, China top new markets for device firms
• Medical device regulations in Israel
• Japanese "device lag" disappearing?
• Asia to get its own Medical Device Directive

For expert translations of regulatory submissions, packaging, and labeling in 40 languages - including Ukrainian - request a detailed proposal from ForeignExchange Translations.

To stay informed, sign up for daily email updates from Medical Translation Insight.
 
 

A patient reported outcome (PRO) measure is a broad term describing any measurement about the patient's health that has come directly from the patient - anything from multidimensional questionnaires assessing health-related quality of life to assessments of single symptoms.

As regulatory agencies increase their support of PRO measures in clinical trials as a basis for submissions, PRO data is becoming an increasingly important part of regulatory submissions. And because PRO measures need to convey the same meaning in each target language, they place unique demands on translation service providers.

The upcoming 5th Patient Reported Outcomes Conference (to be held on November 17 and 18, 2009, in Philadelphia) promises to be an excellent event for health economic staff at sponsor companies and medical translation service providers alike. The agenda is filled with hands-on workshops and expert presentations.

ForeignExchange will be at the PRO Forum. If you are attending, please stop by and introduce yourself as a blog reader. We hope to see you in Philly!


For your next linguistic validation project, be sure to obtain a detailed proposal from ForeignExchange Translations.
 
 

To many people around the world, using English mixed in with their native tongue is almost second nature. As new terms (particularly in the area of technology) are first coined in English, almost all languages find themselves "invaded" by Anglicisms.

But for many folks, this widespread influence of the English language isn't welcome. And nobody has been as consistent (and determined) to fight this trend then the French government.

A wonderful piece by Max Colchester in the Wall Street Journal reveals some of the challenges associated with this effort in general and with coining a French equivalent for "cloud computing" specifically.

To translate the English term for computing resources that can be accessed on demand on the Internet, a group of French experts had spent 18 months coming up with "informatique en nuage," which literally means "computing in cloud."

France's General Commission of Terminology and Neology - a 17-member group of professors, linguists, scientists and a former ambassador - was gathered in a building overlooking the Louvre to approve the term.

"What? This means nothing to me. I put a 'cloud' of milk in my tea!" exclaimed Jean Saint-Geours, a French writer and member of the Terminology Commission. "Send it back and start again"

As TimesOnline points out, this kind of attention to minute details of everyday live may sound a little Orwellian but the language campaign of recent decades has had some success. Over the years, French coinages have driven out some English terms and even improved on them. Ordinateur, invented by an IBM engineer in the 1950s, prevented France joining the computer bandwagon. The French term for email - courriel - was approved in 2003 and has since become popular.

It sounds like there is a bit of leeway given to people too cool to abandon foreign terms (unless you happen to work for the state, that is). Quoted in the WSJ article, the head of the French Delegation for the French Language said:

"We won't cut people's heads off if they don't use it [but] language is what brought this country together."

Want to make sure that you don't commit the faux pas of calling un hotline instead of dialing un numéro d'assistance? Be sure to consult the glossary of indigenous terms published by the Ministry of Culture's language agency.


For other examples of language-tweaking, see:

• Slovak language law creates uproar
• Brazilian Portuguese changes spelling rules

Medical device and pharmaceutical companies require French translations with that certain je ne sais quoi - ask ForeignExchange Translations for a detailed proposal!