Medical Translation Insight

Terminology management is near and dear to us here at Medical Translation Insight.

Unfortunately, when translation service providers are trying to decide which glossary management tools they should buy, they are easily confused or even mislead. Marketing messages like "boost your productivity" or "maximum efficiency" may sound tempting, but usually conceal a blind spot in the tool vendors' claims. A lot of times, going with a simple and inexpensive solution is the best way to get started.

Lost (and found) in localization recently featured an article on how to build a free or low-cost terminology management system. The approach isn't particularly novel but it serves as a good reminder that terminology management doesn't necessarily need to be fancy or complicated or expensive.

The basic idea is to use a web-based spreadsheet to build, manage, and share a terminology glossary (click on the image for a larger version):


The actual Google Docs sample termbase is located here.

Spreadsheets are well suited for glossaries: you can easily move columns around, insert new columns or hide existing ones, sort your data alphabetically, export the content into tab-delimited exchange files. And by using a web-based spreadsheet (if you don't like Google Docs, check out Zoho), it becomes easy to collaborate with co-workers, suppliers, or clients.

A spreadsheet will only take you so far, of course. As your needs and your glossaries grow, you can always investigate a more professional (and expensive) terminology management systems like MultiTerm.


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It seems like every company out there wants to go global. There is a lot of hype involved and as we mentioned before, getting local, expert assistance is key to ensuring success of your global ventures.

But as companies rush to become more global, it is easy to overlook how badly many have stumbled in their globalization strategies. The year-old Harvard Business Review article When You Shouldn't Go Global does the kind of analysis that firms should be doing as they evaluate whether or not to expand globally.

What's refreshing about this article is that the authors don't just look at success stories. They also dig up examples of companies that went global and flopped - and then suggest pitfalls to avoid.

It all boils down to three questions to ask before going global:

1. Could the strategy generate substantial benefits for our firm?
2. Do we have the capabilities needed to achieve those benefits?
3. Will the benefits outweigh the costs?

The bottom line: You don't want to move full speed ahead toward failure. Trying to avoid failure may not sound as glamorous as aspiring to great success, but, on the other hand, having your career derailed because of a catastrophe isn't glamorous, either.

[Hat tip to BNET]

Further reading:

• Six reasons not to translate your web site takes a contrarian view of the rush to web globalization.
• Why international web sites fail debunks the "build it and they will" come myth.

ForeignExchange Translations provides specialized translations of quality/process specifications, chemical manufacturing control documents, legal contracts, and HR materials to drug and device companies. Contact us to learn more.
 
 

The recent post about the fragmented state of the translation business on Adam Wooten's excellent T&I Business Blog did a good job driving home the point that there are lots and lots of small translation companies. Adam's data was pulled from recent U.S. Census reports yet it mirrors some of the findings in the recent EC-backed study Size of the language industry in the EU.

Interesting stuff, for sure, but inquiring minds wanted to know more, namely where the "centers" of the translation industry are. Because neither data set included information regarding the geographic distribution of translation companies, we turned to LinkedIn's company directory for help.

Reflecting the fact LinkedIn's users are primarily based in North America and Europe, the locales listed are limited to those geographies. Nonetheless, the 250 cities and regions that are included range from Aberdeen, Scotland to Zurich, Switzerland.

Here are the locales with the largest number of translation companies listed:

It's interesting to note that the northeast corridor from Washington to Boston is home to 50% more translation companies than California. Similarly, who would have thought that Spain would rank so high?

Clearly there are advantages as well as disadvantages to all of these locales. However, if you are looking be in the center of our industry, it sure helps to be located in one of these areas!


ForeignExchange is smack in the center of the translation industry with offices in Boston, Denver, and Madrid. Contact us for more information on our specialized medical translation services for drug and device companies.

A couple of weeks ago, the U.S. Food and Drug Administration (FDA) announced that the final version [PDF link] of its February 2006 draft guidance on patient-reported outcome (PRO) measures is now available. The final document explains the design and evaluation of PRO instruments, as well as clinical trial design and data analysis considerations when using PRO measures.

In some aspects, the final guidance tracks the draft. For instance, both versions define the term "claim" ("A statement of treatment benefit."). In addition, both address the development and assessment of PRO instruments, as well as the design of clinical trials and analysis of data involving PRO instruments.

Consistent with FDA's general preference for sponsors to discuss clinical development issues early in the regulatory review period, the final guidance retains the recommendation in the draft that sponsors consider whether the use of PRO instruments may be warranted early in the product development process in order to ensure that all applicable regulatory expectations with respect to these instruments may be addressed.

But, as outlined by Sidley Austin, the final guidance differs from the draft in several ways:

• It emphasizes that sponsors should define the "role a PRO endpoint is intended to play in the clinical trial (i.e., a primary, key secondary, or exploratory endpoint)" before a PRO instrument is developed.
• It encourages sponsors to link potential labeling claims to specific clinical trials designed to assess the planned concepts by using a target product profile.
• It emphasizes to a greater extent the concept of content validity, or "the extent to which the instrument measures the concept of interest," and states that content validity must be established "before other measurement properties are validated."
• It does not mention any specific analytical methods used to account for missing data.
• It includes a description of challenges related to developing PRO instruments for multiple cultures or languages.

While this last point is not given much space, the fact that FDA says that "We will review the process used to translate and culturally adapt the instrument for populations that will use them in the trial" is sure to increase the demand for ISPOR-compliant linguistic validations.

For more information on FDA's final guidance, check out FDA Law Blog's good overview and DIA's upcoming webinar.


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

We have previously sung the praises of QA tool ApSic Xbench and how it helps improve the quality of translated files. We would now like to highlight a different tool: QA Distiller. This tool is quite similar to ApSIC, however it is more comprehensive and generally has more functionality.

QA Distiller automatically detects formal errors in translations and TMs, and enables their quick and easy correction. It also batch processes files (it QAs multiple files at a time) and supports language dependent settings. QA Distiller allows you to check for errors in bilingual TTX, RTF, TMX, XML, translation memories and bilingual STF (Framemaker) files. You can also do terminology checks using TBX (TermBase eXchange) dictionaries and QA Distiller Dictionary files.

Just like XBench, QA Distiller checks for omissions, inconsistencies, formatting errors (both grammatical and linguistic), and terminology issues throughout the translated text. You can edit your files directly in the program by double-clicking on the error messages that appear once you have run your QA.

These links take you directly to the location of the mistake in the original bilingual file and you can correct it on the spot. The TMX files (TMs) are opened in an internal editor where you can easily make the necessary corrections and update your translation memory. You can also produce project-specific reports to use either internally or to send to linguistic teams for revision of the mistakes found.

Here are some of the additional features that differentiate QA Distiller from Xbench. QA Distiller can:

• convert Excel glossaries to QA Distiller dictionary files so you don’t need MultiTerm to convert them to XML (which is necessary in Xbench);
• look for corrupted characters;
• assign a “Severity” level to the errors found;
• do "Language Dependent Checks", where parameters can be set for a specific language (decimals, number format, quotation marks format, measurement system, etc.).

One of the main problems with similar QA tools is that they generate long lists of errors that, in many cases, are not all true mistakes. Review of these "false positives" can be quite time consuming.

QA Distiller contains extensive options for reducing the number of false error messages. You can build generic or language specific exception lists to ensure that certain strings are ignored when running QA checks. Additionally, regular expressions can be used to make sure QA Distiller ignores or checks certain pattern matches.

In summary, the use of QA Distiller can make an important difference in the final quality of translated files, as it can both prevent common issues and detect errors that are easily overlooked. The use of this tool can therefore save a significant amount of time during quality control steps.

For more information about this tool and purchasing options, please visit the QA Distiller website.


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

From all of us here at ForeignExchange Translations to all of our clients, suppliers, partners, colleagues, and friends - we wish you a merry Christmas and a healthy and happy 2010!



And if you need some inspiration on how to celebrate and decorate "in style", you can get some inspiration here.

Merry Christmas!

We are winding down our best year ever. In 2009, the ForeignExchange team produced record revenue, handled more projects than ever, and delivered to our clients the best quality ever. Truly amazing accomplishments by our team!

And 2010 looks to be even busier. To help manage our substantial growth, we are currently hiring highly motivated team members in the following areas:

>> Linguistic Lead
Working from our Massachusetts or Colorado office, set the linguistic strategy for assigned clients and projects, act as translator point of contact, and perform linguistic analysis and QA tasks.

>> Director of Business Development
Based in a home office in Minnesota or Illinois, qualify and win new business from assigned clients. 10+ years prior sales experience, preferably in a service industry. Solid track record of achieving forecast targets.

>> Account Manager
Manage relationships with assigned client accounts, develop account growth strategies, and provide input to pre-sales planning, resourcing, and quoting. Based in Colorado.

>> Web Content Specialist
Working in our Massachusetts office, write informative articles and posts. Reach out to and participate in online communities and networks. Create brand name recognition.

>> Audio Conference Production Assistant
Experience the entire AC production process, from planning to recruiting to producing events to supporting clients. Working out of our Massachusetts office, apply skills with HTML, web design, and editing of audio and image files.

>> Product Marketing Manager - Training/eLearning
Based in Massachusetts, can be full- or part-time. Use training/e-learning expertise to spearhead ForeignExchange's marketing efforts, including market analysis, messaging, promotions, and lead development.

>> Business Development Representative
Use 1-2 years proven success in a sales support role to identify, develop, and qualify sales leads. Can be based in Massachusetts or Nova Scotia.

If you know anybody who is looking for a new challenge in 2010, please point them our way. ForeignExchange offers one of the best teams in the industry plus:

• competitive base salary;
• incentive-driven compensation;
• attractive benefits, including medical, dental, and 401(k);
• a professional, high-energy work environment;
• an anything-goes dress code;
• a strong voice in building our successful company!

Motivated individuals who are ready to make a difference can email a compelling cover letter and CV/resume to us at ma-careers ~at~ fxtrans dot com.


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When we asked Why aren't there more medical translation conferences? earlier this year, one of our readers approached me afterward and urged "The last thing we need is yet another translation event!"

His reaction came to mind when I heard about the new Journal of Internationalisation and Localisation. Do we really need one more translation publication?

That's not to minimize or take away anything from JIAL. The peer-reviewed journal clearly takes its task seriously, and a couple of the articles are well worth reading. But is this information that we couldn't have gotten elsewhere? Does it justify the effort that must have gone into producing a 193-page (!) publication.

JIAL's editorial board includes well-known and respected members of our industry. These are people whose insight, commentary, and viewpoints I would love to hear - but is this the best use of their time?

Ultimately, though, that's not for me to decide, and I wish them lots of success with JIAL. May it avoid the fate of "the business resource for a multilingual age" and other long-gone translation publications.

[Picked up from @localization]


Medical Translation Insight is on Twitter! Follow us at @fxtrans.
 
 

Hey, we're not above having some fun with language. We have previously talked about the huge difference that two small letter can make as well as the never-ending stream of entertainment provided at Signspotting.com.

So you can imagine that we are still giggling after seeing these two signs from a castle near Prague:




The Czech text seems to be closer to "Interpretation prohibited" and is probably intended to prevent noisy tourist packs from annoying other visitors. Hmm, makes you wonder how say say "We don't want your economy-sustaining tourist money" in Czech...

[Tip of the hat to ElPadawan and Übersetzungsfehler]


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Some of our device clients maintain IFUs in 30 languages. For many companies, what started out 15 years ago with a handful of languages added to English, labeling has become an entire department, consuming huge resources and time.

It's no wonder then that medical device companies are eager to move towards "e-labeling". The term usually refers to providing Instructions for Use in an electronic format but is bandied about so loosely that it also covers any alternative delivery mechanism - fax on demand, telephone, and so on.

Device companies are excited about the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC. They 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 an upcoming audio conference, Salma Michor will look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

Additional information:

• EU Labeling for Medical Devices takes a look at e-labeling from the perspective of risk management.
• While geared towards IVD manufacturers, Making instructions for use available in Europe nonetheless contains a good analysis of common labeling approaches.
• MEDDEV 2.14/3 REV 1 [PDF link] started it all.

ForeignExchange Translations provides specialized translations for medical device IFUs, operating manuals, and product labels.
 
 

"Raw data, including translation memory data, has no value per se".

Or so is the opinion of Jost Zetzsche, as expressed in the current Translation Journal. In the article, he ponders the sudden availability of large amounts of bilingual data that can be used in translation memories ("TMs").

What is interesting about Jost's piece is that it goes beyond the question of "is a huge, shared TM a good idea?" (we have weighed-in on this before) and poses a more fundamental question:

Is bigger really better when it comes to TMs? Or: Is there a point where a TM jumps the shark by becoming too large, too unwieldy, and too cumbersome?

Jost does a nice job providing pros and cons. And from our own experience here at ForeignExchange, I can also say that it's impossible to give a black-and-white answer. However, what is very clear is that size for the sake of size is not a good thing.

In fact, we have recently gone the other way, proactively reducing the size of TMs by separating them (by client, division, product group, etc.) and culling segments based on age or attributes. Like Jost, we have started to wonder whether or not we are spending too much time updating old, outdated segments.

This "small is beautiful" approach is yielding better output and an overall lower cost - even though we are pulling somewhat fewer matches from TMs. Like all TM efforts, though, it needs to be managed.

The appeal of large "Big Mama" TMs is that they're easier to administer. Just throw anything in there. Being selective about TM contents means that a human specialist has to make manual determinations about what segments should and should not be included. In the current economic environment, that flies in the face of "doing more with less".

What is your approach to TMs: Small and beautiful? Or Big Mama style?


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

The current issue of Medical Device & Diagnostic Industry features an interesting look at the global medical device industry. FDA Outreach Boosts the Number of U.S. Device Firms contains an interesting look at the geographical distribution of medtech firms around the U.S. and Europe.

The results of MD&DI's number-crunching are pretty dramatic: California is the undisputed leader, being home to almost twice as many publicly traded medical technology companies as the next geographies.

Here is a look at which U.S. states are home to publicly traded device companies (note that California is divided into northern and southern in this chart):


And a similar look at the European medtech industry:


As interesting is a look at the distribution of all registered medical technology companies across the U.S. A whopping 20% of device firms are registered in California:


Runners up are Florida with 8% of registered medical device companies, followed by New York, Texas and Illinois (5% each), and Massachusetts and New Jersey (4% each). If you are looking to be in the medical device industry (either directly or as a supplier), it sure helps to be located in one of those areas!


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

Slowly but surely, the controversial health care bill is making its way through the U.S. Senate. After all the ups and downs, it's starting to look like some form of reform will come to the U.S. after all. And where there is change, there is a business opportunity.

This was driven home by Microsoft's announcement last week that it is acquiring health care IT and identity management company Sentillion. Microsoft's move served as one more reminder of industry's efforts to capitalize on the changing health care landscape.

Microsoft has greatly increased its presence in the health care IT space in 2009. Six months ago, the Microsoft and the American Medical Association announced plans to give physicians access to patient records stored in Microsoft's HealthVault application via a Web-based portal. This came on the heels of an April announcement that the Mayo Clinic would use HealthVault technology, thus allowing patients to upload data from home health devices and receive reminders about their medical care. As Peter Neupert, corporate vice president of Microsoft's Health Solutions Group points out in a rather self-serving manner: "Reform and innovation are inseparable."

Microsoft's push to manage all of our health data is getting help from a lot of think tanks and consultants. As reported in Information Age, in June 2009, a report entitled "It's ours: Why we, not the government, must own our data" was published by the Centre for Policy Studies, a right-wing UK think tank. That report, which introduced the topic of data handling to the classic private versus public debate, seemed to strike a chord with senior members of the Conservative party in the UK.

Clearly there is money to be made. For example, Kaiser Permanente, a nonprofit health plan based in California, spent $4 billion making the switch from paper to electronic records, in what Kaiser claims was the largest nonmilitary installation in the country. With that much money at stake, it's a question of "when?" not "if?" the health care backbone will be run by companies like Google and Microsoft.

So, are you ready for ad-supported prescriptions and malware attacks on networked medical devices?


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In November, our top audio conference list is once again heavy on clinical research topics. Here were the top five educational events during the month of November:

1. Studies in Special Patient Populations: More than Just a Regulatory Requirement


2. GCP for Medical Device Trials: Upcoming Revisions to ISO 14155


3. Developing a Post-Approval Labeling Risk Management Strategy


4. Comparative Effectiveness Research: Threat or Opportunity?


5. Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine

If you have any suggestions for audio conference topics, send us a note!

And if you are interested in other popular educational events, take a look at our top audio conferences for September, August, and July.


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Translation memories are great - IF the TM databases are clean and IF the source files are well structured. Unfortunately, that is not always the case.

Luckily, Dave Turner has taken it upon himself to remedy this situation. He has developed and made available free of charge two terrific tools.

The first is his Code Zapper macro, which can be used to remove rogue codes. For example, it moves place markers from the middle of words to the end of the paragraph.

Dave then followed this up with Format Fixer, which:

• deletes leading spaces and tabs inserted typewriter style to indent text, and sets the equivalent indent,
• deletes excess spaces between words,
• deletes excess paragraph marks and sets the equivalent vertical spacing,
• attempts to correct frequent punctuation errors (space before comma or inside a parenthesis for example),
• tries to fix PDF converted files (removes hard and soft returns to make text wrap properly),
• adds a space between a number and a letter as in 20ohm, 10daN -> 20 ohm, 10 daN

Code Zapper as well as Format Fixer are available free of charge on Yahoo!Groups dejavu-l forum and can be used with any TM system. Check them out!

[Thanks to Kevin Lossner's blog for the tip!]

UPDATE 2010-01-02: Dave Turner published an updated version of CodeZapper that features improvements in the PDFTidy and PDFFix routines. PDFTidy should provide better tidying up of PDF converted files before CZ is run. PDFFix should provide better elimination of stubborn rogue codes, especially in PDF converted files.

For more neat TM tools, check out these resources:

• CSVConverter is a free utility that converts glossaries stored in CSV (Comma Separated Values) to TMX (Translation Memory eXchange) standard.
• We recently looked at different options for taking the pain out of translating text in images.
• And if you are looking for still more tools, check out the mother lode of free localization tools.

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Pharmaceutical companies are hurrying to setup production facilities in China. Some of them are attracted by prospects of China becoming the world's largest pharmaceutical market. Other drug companies are attracted by the chance to save costs. But all of them are heading east to take advantage of the comparatively lax regulatory system.

Nearly 80% [PDF link] of all drug substances are manufactured outside of the US. As we have seen with the contaminated heparin from China, there has been lackadaisical GMP oversight at many foreign facilities.

Unfortunately, the situation hasn't improved. BNET Pharma reported that FDA has only 2 inspectors watching drug factories in China and that the EU inspects fewer than 19 Chinese pharma factories annually.

There are real safety worries here (2008's heparin contamination was awful - just imagine what could lie ahead) but in a twist of fate, medical translators stand to reap huge rewards from this situation.

Pharma's move to China foretells huge needs for Chinese translation: With more and more pharmaceutical companies setup shop in China, there will be a huge increase in the need for Chinese versions of hiring materials, training documents, CMC and manufacturing specs, audit checklists... The list of materials to be translated goes on and on.

This puts medical translators in the uncomfortable position of benefiting financially from a broken oversight system in China that could do significant harm and even lead to more deaths. It may not be on the level of working on animal testing projects but it may still raise ethical questions among translation service providers.

2009-12-10 UPDATE: Here is an odd spin on the safety issue - FDA Dislikes Canadian Drugs; Is OK With Chinese Drugs.


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Last week, the European Union Council agreed on a roadmap [PDF link] towards a single European patent system. The regime is seen as key to making patenting less expensive and more efficient for European inventors.

But the devil, as always, is in the details. And one of the main "details" is the language regime for an EU patent. As in the past, discussions have stumbled over which of the EU's 23 languages should be the official language for the patent system.

Currently, the closest thing to an EU-wide patent is provided by the European Patent Office, which isn't part of the EU. Once the office issues the patent it breaks up into a bundle of national patents, forcing companies to defend them individually in each country, which can cost as much as half a million euros in a typical case but the translation costs for long and complex cases are potentially enormous.

Sweden holds the rotating six-month EU presidency until the end of this year. So, its promise that "[the] translation issue will be resolved in a special regulation" will be lived up to (or not) on somebody else's watch.

[Hat tip to @tomedes]


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

Betty Galiano, a member of the Board of Directors at Tremedica, let me know about the glossary of Spanish acronyms and abbreviations that is available on their site.

Like other dictionaries and glossaries, it is valuable but has its limits. Entries seem pretty extensive but are short, with no links further information. A big plus is that the glossary was compiled by Fernando Navarro, the author of the renowned Diccionario crítico de dudas inglés-español de medicina.

While you are on Tremedica's web site, check out the association. It is primarilyfor Spanish speaking linguists but the material they publish is fantastic; it is worth becoming a member. The annual fee is low in comparison to the information and publications you get from them.


Why do leading pharmaceutical companies entrust their Spanish medical translations for regulatory submissions to ForeignExchange Translations? Our process allows for known translation quality in the shortest amount of time. Ask us how!
 
 

For many drug and device companies, being able to estimate the cost of translation remains an impenetrable mystery.

Just in time for budgeting season, Pharmaceutical Executive published a five-step approach to developing accurate translation budgets:

1. Outline - Define the work that you need to get done
2. Review - Go back to previous years to see how many of these projects you had translated
3. Track - Analyze past work for price changes and efficiency gains
4. Prepare - Look into your crystal ball for regulatory changes, product roll-outs, and new market
5. Pull it together - Combine expected projects with schedules and prices

Increasingly, translations are a critical function for global medical device and biopharma companies. By putting in place a robust translation budgeting process, companies ensure that their translation dollars, euros and yens go further.


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

Fall has gone by in a hurry! So quickly, in fact, that we didn't even have time to write-up our most popular post list for October. So, here are two months' worth of roundups.

In November, the posts that received the most attention were:

1. Taking the pain out of translating text in images - Many medical translators are struggling with this; it's nice to see that translating text in images is getting a little easier.


2. Is Google Translate accurate enough for professional use? - It's easy to dismiss the Big G as just another MT toy but real-world uses are starting to emerge.


3. Quality is dead - long live measurable quality - Please, no more talk about how "we deliver quality because we use separate translators, editors, and proofreaders", OK?


4. "Employee-sourcing" the new crowdsourcing? - Is this just an IBM thing or is the pendulum swinging back to bringing translation in-house?


5. Regional file format requirements for eCTD - Kathie Clark's guest article provides a good overview of the global state of eCTD requirements.

In October, these five posts attracted the most readers:

1. Measurably improve translation quality in 60 days - Localization World Silicon Valley featured a hands-on workshop on how device and drug companies can measure and improve their translation quality.


2. Free translation, localization tools - Everybody likes a freebie, right? If you do, check out this collection of free localization tools.


3. TERMIUM price reduced to - nothing - Free is good but being able to use TERMIUM for free is amazing!


4. Big step forward for crowdsourced translations - Facebook is leading the charge for crowdsourcing of translations.


5. SharePoint in the life sciences - SharePoint is all the rage and our audio conference on the topic was one of the year's best sellers.

Interested in past months' most popular articles? Take a look at our roundups for September, August, and July. Happy reading!

Clinical research is fundamentally changing: First clinical trials are going global and second Quality of Life (QoL) data is becoming more and more important during drug clinical research.

QoL data has always been part of clinical research, of course. Recently though there have been a couple of developments that have pushed QoL into the foreground: On the one hand, pharmaceutical companies are looking for non-scientific justifications to broaden the claims for their medicines. On the other hand, patients are increasingly interested in minimizing side effects of the treatment that they receive so that they can go on living as normal a life as possible.

The challenge is that QoL data, which is almost synonymous with patient-reported outcomes (PROs) in clinical trials, is highly subjective and thus open to "creative" marketing claims. That is difficult enough for English-only trials (most QoL questionnaires are written in English) but becomes a real challenge because of the above-mentioned globalization of clinical research.

The translation and validation of PROs is a laborious (read: time-consuming and expensive) process that seems foreign to most medical translators. (You can get a sense of the complexities by reading Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases.)

Luckily, there is help available. the excellent Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments provides the "gold standard" for the translation and validation of PROs.

The book is divided into six easy-to-use chapters and provides lots of hands-on information such as process diagrams and decision-making trees.

While Linguistic Validation Manual follows the basic process outlined in Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation and others, it also goes beyond it. For instance, the book provides more details regarding participants, different types of process flows, and variations in languages (i.e., questionnaires that were developed in languages other than English).

Linguistic Validation Manual is highly recommended for anybody interested in learning about the translation and validation of PROs.


For further reading, also take a look at:

• Our recent audio conference on Translation & Linguistic Validation of PRO Measures
• Ideas for using translation memories in clinical research settings
• FDA's draft guidance on PROs

ForeignExchange Translations provides specialized medical translations for clinical trial applications, protocols, informed consents, patient diaries, INDs, patient recruitment, and health economic research. Contact us for more information about our clinical translation services.
 
 

The folks at reg-info Live have compiled a list of 14 pharma-related glossaries. The glossaries explain concepts, acronyms and jargon used in clinical and regulatory settings.

While the glossaries are in English only and are focused primarily on Europe, several of them provide good insight into narrow fields. The "Danish Medicines Agency Glossary" and "Eudralex GMP Glossary", in particular, contain good explanations of specialized expressions.

So head on over to reg-info Live and bookmark those glossaries that are of interest to you. And in case you missed them, make sure you check out these terminology resources that we previously covered:

• The Medical Spanish Podcast is - you guessed it! - a Spanish-language podcast for health care professionals.
• CCHCP maintains a veritable treasure trove of medical glossaries.
• DeafMD.org provides medical terminology in American Sign Language.

ForeignExchange Translations provides specialized translations in support of the entire pharmaceutical product lifecycle. Ask for a detailed quote on your next project!
 
 

The final countdown is on: As of next Tuesday, EMEA will be no more.

Well, the European Medicines Agency will still exist but it will be called "EMA". The agency is planning wide-ranging updates to its web site, logo, and visual identity.

The most significant change will come to the agency's web site and email addresses: Starting December 8, the 'emea' part of all website and email addresses will change to 'ema'.

For all of the details, read the official announcement [PDF link]. And on December 8, be sure to check out the new www.ema.europa.eu.


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