;   Medical Translation Insight - ForeignExchange Translations

Goodbye EN 15038, hello ISO 17000

Goodbye EN 15038, hello ISO 17000 (medical translation)
Medical translation companies' quality systems are typically certified to ISO 9001 (or other industry specific ISO standards such as 13485, 14971). However, there has been an absence of translation-specific ISO standards. EN 15038 was published in 2006, and has been widely accepted by translation companies, in an effort to fill this gap. Now ISO 17100 is scheduled for release in late 2014 or early 2015, and it is intended to act as the international version of EN 15038 and replace the old standard.

There are some differences between EN 15038 and ISO 17100 but they are fairly minor. For anyone certified to EN 15038, the migration to the new standard should be seamless. Medical translation providers will have three years to migrate to the new ISO 17100, if they are already certified to the EN 15038 standard. This will allow time for registered bodies to prepare to complete audits against the new standard.

It's important to note there are more extensive differences with the U.S. standard ASTM F2575, which could present challenges to those not already certified to EN 15038. Also, the other ISO standard in the translation realm to be aware of is ISO/TS 11669, which was released in 2012. ISO 11669 is a technical specification (not a full standard) and standardizes the description of translation projects. Its intent is to provide buyers and suppliers with a framework in which to define quality requirements and to effectively manage translation assignments.

Importantly, actual translation quality is not defined in EN 15038, ISO 17100, or ISO/TS 11669. Medical translation providers will need to continue to find other sources to define their target translation quality levels. Some options include SAE J2450 (specific to the automotive industry), ForeignExchange's METRiQ (specific to the medical device and pharmaceutical industries), or even the old LISA QA model.

For more information on translation quality measurements, check out our new book The Definitive Guide to Measured Translation Quality.


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

We're looking for a Senior Technology Strategist
ForeignExchange is having another amazing growth year. To support our growing organization, new and growing client relationships, new service offerings, and an expanded geographic footprint, we are looking to hire a technology leader.

The Senior Technology Strategist identifies, prioritizes and manages the execution of creating solutions using a set of application platforms supported by the organization. This leadership position also investigates the latest technology solutions available and determines if they are a best fit for the organizational strategy and enable more efficient and effective delivery of services and solutions to the customer, including:
  • Identify technology that will help win business and drive revenue
  • Identify technology that will maximize efficiencies and/or increase quality
  • Identify technology solutions to help provide services and partnerships to our clients
  • Oversee the development, purchase, implementation of technologies corporate wide
We are looking for an experienced manager with extensive technology leadership experience in the translation / localization space. This position can be based anywhere (one of our offices or remotely), and some of the responsibilities of this exciting role include:
  • Develop and build consensus for a strategic vision and roadmap for the organization to identify and prioritize business process solution projects, consistent with the business strategies
  • Responsible for analyzing and translating business, information and technical requirements into an architectural blueprint that outlines solutions to achieve business objectives
  • Strengthen ForeignExchange's competitive edge
  • Creates and maintains long term roadmap for technology development, in collaboration with Solutions Development and Operations
  • Eliminate time, effort, and costs, directing continuous process improvements and high-impact change
  • Recommends department budget to ForeignExchange's COO and ensures function operates within budget
  • Develops Total Cost of Ownership (TCO) and Return on Investment (ROI) analyses for proposed technology projects
If you are a go-getter who has a proven track record of implementing technology strategies in a mid-size translation company, we would love to welcome you to the ForeignExchange team. When you are ready to make a difference, email your resume and compelling cover letter to co-careers@fxtrans.com.


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Primer: Linguistic validation

Primer: Linguistic validation (medical translation)Increasingly, large-scale clinical trial programs are conducted in non-English countries, and the need to translate and adapt clinical trial documentation for use in other than the source language continues to rise in demand.

A key methodology for the evaluation of therapies is the randomized controlled trial. These clinical trials traditionally relied on relatively objective clinical outcome measures, such as cure, biological response to treatment, or survival.

In recent years, however, patients and investigators alike have argued that subjective indicators should be considered as well. These indicators are regarded as indicators of quality of life. Many questionnaires, or instruments, have been developed for quality of life assessment, and the demand to translate them has increased year after year.

The translation of these Quality of Life (Qol) or Patient Reported Outcomes (PROs) is referred to as Linguistic Validation. The name implies both linguistic and conceptual equivalence across languages and cultures, and is achieved through the most intricate methodology in the translation industry.

The Linguistic Validation process includes two forward translations performed by native speakers of the target languages who are working independently. It is then followed by a reconciliation of the forward translations into a first draft translation by another native speaker of the target language.

This linguist, known as the Reconciler, plays a key role in the Linguistic Validation methodology, because it is the Reconciler who updates the draft translation several times during the process and who ultimately has the final say on whether or not the translation may be considered final and, thus, validated.

After Reconciliation, the reconciled version is back translated into the source language by a native speaker of the source language, usually English. The Back Translation (BT) step is followed by a comparison of the BT and the source, called Comparative Review, performed by a native speaker of the source language who has undergone our Comparative Review training.

The draft translation is then updated by the Reconciler and sent for review to a clinician in the target locale and in the specialization targeted by the instrument. The draft translation is updated again, if necessary, formatted, and sent to a healthcare professional who interviews five patients who have the disease or condition targeted by the instrument.

This interview process is called Cognitive Debriefing. Patients are asked if they understand the translations, if the language is offensive or irrelevant to them, and if they would change any of the wording. Patient feedback is evaluated after the Cognitive Debriefing step, and, once again, the draft translation is revised by the Reconciler, if needed. Finally, the validated translation is formatted and final review before delivery to the customer.

For more on linguistic validation for Qol and PROs, take a look at the following:


ForeignExchange Translations provides specialized medical translation support for all stages of drug and device clinical research.
 

Medical translation research
Researching medical terminology is a big and important part of every medical translator's professional life. There are hundreds of resources for medical translators online - for different language pairs and different areas of specialization. Karen Sexton compiled five especially useful tools on her blog. Here is how she selected them:
  • Medilexicon: This dictionary also features in my dictionaries post. I love it particularly for acronym search in clinical trial and patent translations. It is comprehensive and extremely useful when translating from English. It also contains a dictionary with definitions, which is useful, but the main resource I use is the abbreviations search.
  • Pubmed: This is a database of scientific articles from virtually all relevant international journals. When I worked as a medical researcher a few years back, this was the most popular search engine for scientific references. I believe it is still one of the most used by scientists worldwide and it is great because it contains articles from reputable journals. Hence, you have access to higher-level information. The only drawback of this website is that if you are not subscribed, you only have access to the abstracts of most articles. In my experience, the information I need is usually in the abstracts and when it is not, I can usually find some clues there that will guide further research.
  • ScienceDaily: I like this website because you can search for summaries of research in different topics. I find it particularly useful when the information I need is not clear from the abstracts on PubMed. I usually use the clues from PubMed as search topics on Science Daily to get better clarification on the terminology that I am translating.
  • Medline: The US national library of medicine. This is also a great resource for research. It is important that medical translators have a thorough understanding of the topics they are translating about before they even begin translating. Hence, having links for good, sound information on a variety of medical topics in your bookmarks bar is essential. This is definitely one such resource.
  • LILACS: LILACS is the most important and comprehensive index of scientific and technical literature of Latin America and the Caribbean. This is particularly useful for translators into and from Latin American languages and it gives access to full articles from Latin American Journals. It is also useful for translators of other languages doing research in English as most of the articles are in English, but Latin American translators are able to find the references and then search for the articles in their respective languages. Hence, I find it very handy when trying to decide how to translate a particular term.
These are indeed very useful resources. Check them out and be sure to subscribe to Karen's blog!


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

25th Life Sciences roundtable at Localization WorldThe 25th edition of Localization World kicked off in Dublin on Tuesday with the Life Science roundtable. With 24 attendees, this was one of the largest roundtables to-date.

A number of topics were discussed ranging from the new trends towards content "digitalization" and what it means to medical translation suppliers. As in the past, there were a number of sessions on technology. The panel on the pros and cons of TMS implementation co-hosted by Aurélie Baechelen of Varian Medical Systems and Sandra La Brasca of ForeignExchange Translations sparked a lively discussion from both the supplier and client side.

There were two separate presentations that focused on the content challenges faced by medical device and pharmaceutical companies and how to address them through focused process analysis and technology. As with previous roundtables, third-party review emerged as an area that remains a challenge for both suppliers and buyers.

Last but not least, there were presentations about the growth of the medical translation market. As one would expect, the consensus was that the BRIC countries seem to be the countries that will see the most growth in the next few years.

While the topics were very diverse, there was a clear theme that emerged from all the discussions: in essence all parties agree that successful projects rely on solid processes, sound technology decisions, and clean data - but first and foremost partnership between buyer and suppliers. This roundtable was very informative and we look forward to the next edition in Vancouver!


ForeignExchange supports the world's leading medical device and pharmaceutical companies with specialized medical translation services for regulatory, clinical, and marketing efforts.
 
 

Thursday June 12th, 2014
8:30am Breakfast and Networking
9:00am – 11:00am Presentation and Discussion

Translation is an arcane discipline, where state-of-the-art technology comes together with a very human process. Done well, medical translations can save lives by getting products to market faster with the vital information needed for safe, correct use. But it can be expensive and time-consuming, and translation quality can be difficult to measure. Many people don’t know how it works and myths and misconceptions abound.
This seminar is designed to provide attendees with an overview of how translation works and the key elements you need to consider before you take your product global to ensure budgets and schedules stay in control, and your translated content resonates with your international audience.
For more information or to sign up for our event, please visit our sign up page

30% discount for MemoQ Translator Pro - medical translationAfter using MemoQ server for the past several years, ForeignExchange is now using MemoQ as the primary CAT tool on all translation projects.

This decision came out of a comprehensive review of our tools strategy. As part of this review, we compared several CAT tools on usability, TM compatibility, level of support, QA features, TM server technology and pricing. Based on these criteria, we found MemoQ to be the best fit for us and our needs.

Standardizing around MemoQ makes sense because it is a robust platform that will contribute to our growth as a company and help us serve our drug and device clients by providing greater consistency and faster turn-around times.

And as if that wasn't enough, Kilgray, MemoQ's developer, is fun to work with. During the rollout, Kilgray's team has been open to implementing enhancements that allowed a more seamless integration of MemoQ into ForeignExchange's tool set.

István Lengyel from Kilgray also seems to be happy with the collaboration: "ForeignExchange started using MemoQ early, and they had a big impact on the design of the software - making it fit their specific needs. We also believe that ForeignExchange excels in the way they deployed quality metrics. We are proud to be the vendor to them." Thank you for the kind words, István!

MemoQ is also a terrific choice for medical translation providers. Many of our linguists have already added MemoQ to their arsenal of CAT tools. And now we have a special promotion for those who have not yet bought MemoQ: ForeignExchange is happy to announce that we can offer a discount code for 30-40% off MemoQ Translator Pro. To take advantage of these savings, please fill out this short survey by March 7. On March 10, depending how many people are interested, we will provide you with a code for a 30 to 40% disocunt. The discount code will be valid until March 14. Along with the purchase of MemoQ, you can also access the Online Training Course for Translators free of charge.

Please note, though, that to use this discount, you must have signed up via our survey. This promotion is valid for new MemoQ Translator Pro licenses only. Upgrades are not part of this promotion.

This is a great deal, and we encourage all of our linguistis to take advantage of this time-limited offer!


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

Why partnerships between PRO developers and medical translation providers make senseThe goal of Linguistic Validation of Patient Reported Outcomes (PROs) is to achieve linguistic and conceptual equivalence so that data gathered from participants in multinational studies may be pooled across languages and cultures.

A critical component of the linguistic validation process is the creation of a list of concept elaborations during the project preparation stage. The objectives of concept elaborations are to define the instrument's items (questions and/or statements) instructions and response options, highlight potential challenges in translation and suggest solutions wherever possible.

Sample Concept Elaboration

  • Item - I am bothered by headaches
  • Definition - This item seeks to assess if the respondent has had headaches that are disturbing.
  • Potential Translation Challenge -"Bothered" is understood to only mean having in some cultures. The intent of it here is to convey both having the headaches and being disturbed by them.
  • Acceptable Translation Alternative -I have headaches that are disturbing
  • Unacceptable Translation Alternative -I have headaches
Ideally, the instrument's developer (author) would be available to clarify any doubts, thereby eliminating the possibility of misinterpretation of item intent. Without this crucial collaboration, the translation provider must make his or her best educated guess, which is contrary to the objectives of the exercise.

Consider the following items from the same instrument:
  • I am jumpy
  • I am jittery
  • I am on edge
  • I am agitated
All four items are intended to assess the respondent's level of anxiety. However, they are largely synonymous. What are the semantic nuances of each and how does one differentiate between them? One effective strategy is to provide the linguists with a continuum on which the items are listed from "least severe anxiety" to "most severe anxiety". The four "x's" represent the four items, which would be listed in order of severity.

Least Severe Anxiety x_________x__________x__________x Most Severe Anxiety

The developer's input for synonymous terminology is essential to guarantee the intent of each item is defined accurately.

Now, imagine a partnership between developers and translation providers that begins at the time the source items are being created to ensure they have the maximum potential for validity across languages and cultures. The translation provider would perform a translatability review and advise the developer on alternatives for colloquialisms, synonyms, passive language and grammatical structures, which may all pose translation difficulties down the road. A translatability review in conjunction with source item creation would save the study sponsor time and money when both are of the essence.

These partnerships do exist in the industry today; however, additional awareness is needed to promote and nurture them so that they become an integral component of the Linguistic Validation process.

For more on this topic, take a look at the following articles we've written:
ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

ForeignExchange Translations announces the results of its annual Client Satisfaction Survey. This year, ForeignExchange again ranked among some of the world’s leading companies like Apple, American Express, Southwest Airlines and Amazon by earning a high Net Promoter Score (NPS) form its clients. Again, the ForeignExchange Customer Satisfaction Survey proved to be exceptionally helpful in identifying company service levels and strengths, as well as areas where ForeignExchange can make improvements.

Survey results indicated that 99% of ForeignExchange clients are willing to refer ForeignExchange Translations to colleagues – up 1% from 2012. In addition, ForeignExchange earned a NPS rank of 49. Andres Heuberger, President and Founder said, “We are very pleased with the ranking we received from our clients this year, but more importantly, the constructive feedback is what will enable ForeignExchange to best meet our clients needs and  maintain lasting partnerships. We remain dedicated to understanding client feedback and working proactively to improve client satisfaction.”

The Client Satisfaction Survey also included project related questions related to effectively explaining and executing on proposals, timely and clear communication, and translation quality.

Download the full report of the Client Satisfaction Survey here: http://info.fxtrans.com/wp-css-2013-report


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 

ForeignExchange Translations, Inc., today announced the hire of Dana Weiss, as Director of Linguistic Validation.
Dana Weiss will lead the expansion of ForeignExchange's linguistic validation offering and brings 10 years of extensive expertise within Patient Reported Outcomes (PROs). Dana’s experience includes working with authors of internationally recognized instruments, as well as global teams of linguists and clinicians to validate them into over 50 languages.

Andres Heuberger, president of ForeignExchange said, "We are very excited about on-boarding Dana Weiss, her vast experience in Patient Reported Outcomes and experience working at CORE (Center on Outcomes, Research and Education) will further strengthen ForeignExchange's linguistic validation solution offering.


ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.
 



 

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