Medical Translation Insight

It's no secret that 90% of in-country reviews are a waste of time. Yet many medical device manufacturers (for a variety of reasons) continue to conduct these validation steps.

A number of ways exist to streamline reviews. Despite the organizational challenges that often exist, some device manufacturers are actively working to improve review process. And several of our clients are working to minimize the number of reviews that are done.

The approach this getting the most "traction", however, is to outsource in-country reviews.

Clients who outsource in-country reviews (to ForeignExchange or to other specialized providers) generally realize four important benefits:

1. Accountability - By outsourcing, somebody proactively manages reviewers. This results in guaranteed availability, known costs, and the existence of backup reviewers. Records are kept, and clients can pinpoint what changes were made when by what reviewers. Most importantly, though, it affords clients the opportunity to change reviewers in case of quality or turnaround issues.
2. Faster turnaround time — In-country reviews completed with employees of the device client usually take a long time. Weeks and even months are not uncommon. Reviewers often miss the review deadlines, eventually forcing clients to proceed without reviews. By relying on an independent review organization, clients can dramatically cut review times - to days instead of weeks or months. Clients are also assured that translations get reviewed, every time.
3. Quality — Thanks to ForeignExchange's robust methodology for seeking, qualifying, and approving reviewers, the reviewers selected by clients are "known quantities". In contrast to some company-internal reviewers, it will be clear what educational, professional, and linguist background the reviewers have. This results in review comments that are more consistent and more meaningful.
4. Efficiency — Many device companies (incorrectly) believe that reviews are needed for regulatory reasons. By outsourcing this "safety net", clients make optimal use of available resources. It will free up company employees and resources while maximizing the efficiencies that specialist providers like ForeignExchange have achieved in providing this service.

Despite all of these advantages, this service represents an investment for clients. While no device company is looking to spend more on translations, a cost/benefit analysis often demonstrates that this is a smart investment. The ROI comes in the form of reduced time-to-market, increased quality, and improved accountability.

Well managed reviews can be an efficient and effective part of a device company's multilingual publishing cycle. To make sure of that, know why you are reviewing, communicate early, often, and widely - and consider outsourcing your in-country reviews.

For a much more in-depth look at the topic of in-country reviews, attend the upcoming audio conference Best Practices for Managing In-Country Translation Reviews.

Happy reviewing!


ForeignExchange Translations provides outsourced third-party reviews and specialized medical translation services to medical device companies.
 
 

Here is a good resource for those times when you need to look up a medical term. The Multilingual glossary of technical and popular medical terms in nine European Languages contains the electronic form of eight glossaries, in which you can find 1800+ technical and popular medical terms in English, Dutch, French, German, Italian, Spanish, Portuguese, and Danish.

There are four kinds of documents on this system:

1. Lists of technical and popular medical terms: these lists contain an index of all the medical terms, with cross-references between technical and popular terms (one list for each language).
2. Glossaries of technical and popular medical terms: these glossaries contain notes and comments from translators and users for each of the 1830 terms in the selected language. This is where your comments will eventually find their place.
3. Multilingual lemma collection: this list contains 1830 pages, one for each of the concepts in this system. On each page all the technical and popular terms from the all languages are brought together.
4. Dictionary: this list contains a short description (in English) of each term.

The project was commissioned by The European Commission(DG III) and executed by Heymans Institute of Pharmacology and Mercator School, Department of Applied Linguistics.

The system takes a no-frills approach but has proven to be valuable at times. It's another good resource for medical translation providers!

And if you need even more glossaries, check out these resources that we covered in the past:

• Medical Spanish podcast
• List of pharmaceutical glossaries
• English-Chinese medical dictionary
• Medical abbreviations from ITI MedNet

ForeignExchange supports clients' medical translation needs with comprehensive terminology management services and technology. Contact us to find out more!
 
 

That's what one of the comments said for the article Crushing the mushroom: Why translation should be 'reassuringly expensive' on the b2b marketing blog.

Here is a word of caution to anyone who believes this: It is a bunch of hogwash.

The notion of translations needing to be "reassuringly expensive" is based on a fallacy. Translation quality has very little to do with price - and vice versa.

Don't get me wrong - justifying a higher price with superior quality makes sense, and there is nothing wrong with translation service providers maximizing their profitability. But what is wrong is the notion that good quality cannot exist without high prices.

We see this in our own business:

1. When buying linguistic services from freelancers, we see very little connection between quality and price. Some of our best translators are also our least expensive ones. And, at times, we have paid a lot of money for really bad translations.
2. We charge different prices to different clients. Sometimes that's because the process is a little different, and sometimes that's simply because we can. Regardless of whether we charge high or low prices, our quality standard is unwavering.

Translation service providers who cling to the notion that more people involved in a translation will "guarantee" quality (and then use that to justify longer schedules and higher costs) risk getting crushed like the mushrooms in the b2b marketing blog's article.

The future of medical translation (and, really, translation in general) is about subject-matter expertise, effective use of technology, and known, measurable translation quality.


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

It's not just pharma sales that are going global. Recent events highlight how clinical research is also moving from established, mostly Western countries to emerging markets.

Yesterday's news that Charles River Labs is buying its Chinese competitor WuXi took a lot of people by surprise. In discussing the transaction, Bloomberg reports that the Chinese market for contract research is growing as much as 30% annually - more than 3 times as fast as the global growth rate.

What's causing this explosive growth in China and in other emerging markets? The drivers appear to be lower costs, easier access to patients, and fewer hassles.

Conducting a clinical trial in China can be 50% cheaper than a comparative trial in a Western country. Lower labor costs and site fees add up quickly.

With significantly fewer sites competing for patient populations, CROs and sponsors find that patient recruitment in China is easier, allowing research sites to produce more patients than sites in traditional regions.

The "fewer hassles" factor comes in two flavors. First, in the U.S. and Europe, animal-rights activists regularly harass drug makers and researchers and don't shy away from aggressive tactics. It's kind of hard to imagine this happening in China...

Second, the "red tape gap" is widening between China and Western countries. CBC quotes the editor in chief of the Canadian Medical Association Journal as follows:

"[In Canada and other countries,] regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries."

A professor who's also quoted in the same piece makes it even more black-and-white:

"Ten or 15 years back, you have [a] one- or two-page consent ... Now it's a 14-, 15-page consent. And imagine a patient coming in with a heart attack and you're trying to test a potentially useful new drug. To give them a 14-page consent is just, it's meaningless."

No such worries exist in China: According to a 2009 article in the New England Journal of Medicine, 90% of published clinical trials conducted in China in 2004 did not report ethical review of the protocol and only 18% adequately discussed informed consent.

And this is the pickle that drug developers find themselves in: How much patient protection is enough, and are the savings worth reduced quality control and compliance in China?

Stay tuned... We are sure to find out the answers in the years to come.


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

The translation business isn't exactly known for adhering to established norms. From quality definitions to translation memory discounting to service-delivery processes, every translation company pretty much does their own thing.

The same is true when it comes to language and country codes. Say, for instance, you want to identify German. Do you use DE, D, GE, DEU, or something else? Translation companies routinely use all of these and many more abbreviations.

Most of the time, it is easy enough to figure out what someone means but it's easy for translators or clients to get confused. One company's "PO" abbreviation could refer to Polish and another one's to Portuguese.

Fortunately, there exists an easy solution: ISO 639.

As of 2009, four international standards for identifying languages have been approved by the International Organisation for Standardization:

1. ISO 639-1 two-letter codes
2. ISO 639-2 three-letter codes
3. ISO 639-3, also three-letter codes, for all language categories identified by Ethnologue
4. ISO 639-5 for language clusters and groups

The Library of Congress maintains an easy-to-use list of Codes arranged alphabetically by alpha-3/ISO 639-2 Code.

Identifying languages is a good first step. But what if you want to distinguish, say, a Spanish translation for Peru from one intended for Mexico? Or what if a client requests a translation for "IN" - does that refer to Indonesia or India?

Luckily, there is a solution for this as well: ISO 3166 is the International Standard for country codes. It lists 246 official short names and code elements as shown on this list of English country names and code elements. By combining language and country codes, anybody can now distinguish the French spoken in Switzerland (fr_ch) from that of France (fr_fr) and Canada (fr_ca).

So, let's do a favor to ourselves and our clients and use ISO 639 and ISO 3166 to identify languages and countries.

Thanks, Megan, for the idea!

For further reading, take a look at the following articles:

• International standards for date and time
• Wikipedia's entries for IS 639 and ISO 3166
• LangID helps you identify unknown languages

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

Last week, we wrote how 50% of translated Spanish medicine labels contain errors. The article was based on a recently released study that highlighted the dire state of machine translated prescriptions in New York City pharmacies.

As if that study wasn't troubling enough, a different study shows that the problem goes beyond New York City and further than machine translation.

The Unnatural Language Processing blog reported on a recent article in The Oncology Pharmacist. Pharmacists Underuse Language Assistance Services discussed the findings of questionnaires completed by 296 chain and independent community pharmacists nationwide.

What emerges is a picture of pharmacists believing that you are "damned if you do, damned if you don't" provide language assistance services (LAS). For instance, the article states that respondents were hesitant to provide translated information:

"More than half of pharmacists who did not use LAS said their hesitation stemmed from concern about inaccuracies in translation/interpretation."

Even more disconcerting is the fact that roughly 25% of respondents said that they were worried about legal issues.

"Pharmacists said they were worried that they would be liable if the prescription label was printed in a language they did not know and included inaccurate translations"

Whatever the concerns, the fact is that almost half of pharmacists who have LAS fail to notify their patients of its availability.

But the decision not to provide translated information is also putting patients at risk. The article mentions the following case:

"... a pharmacist tried to explain to the Spanish-speaking parents of a 10-month-old girl how to give the prescribed dose of an iron supplement by showing them the dropper and vial. The pharmacist did not speak Spanish, and an interpreter was not used. Although the parents nodded that they understood the pharmacist's directions, instead of using the dropper, they gave a tablespoon of iron to the infant. As a result, the child received a 12.5-fold overdose and had to be hospitalized."

The study's lead author (and publisher of the Unnatural Language Processing blog) prepared the following excellent summary of their findings:


[click on the image for a larger PDF version]

So, how do you bridge the culture and language gap when providing professional translations is too expensive, providing qualified interpreters is unrealistic, and vastly improved machine translation output is still in the far-off future?

It seems that more training for pharmacists is required. Unless these front-line health care professionals understand the underlying language and cultural issues, they cannot begin to bridge the gap. Tools like LAS kiosks, community outreach, and social media can also play a role in helping patients understand the availability - and limitations - of translated information.


[Tip of the hat to Kirti Vashee!]


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

A week ago, I was in Orlando for the Partnerships in Clinical Trials conference. The conference was well-attended by a mix of people from drug companies and CROs. While topics were wide-ranging, from managing virtual teams to the state of the CRO industry, an overriding theme that I detected was one of collaboration and how working together, client and vendor, can help with everything from mitigating risk to keeping costs down to improving patient safety. I was struck how similar this theme is to our own medical translation industry.

One particular panel discussion that I attended stood out. A year ago, the pharma giant, Otsuka, had selected Covance as their contract research partner and the companies gave a one-year update on how the relationship was going, both good and bad. It was refreshing to hear how honest both sides were in their comments, with no sugar-coating and no pulled punches. It was obvious that each party understood their flaws and their competencies and sincerely wanted to work on improvements and making things better.

I also learned about the challenges of making inherited vendor-client relationships work, how 21st century work styles are presenting new challenges, the pitfalls of clinical trials in emerging markets and how sponsor companies go about their RFP process to select a CRO. All good stuff. Keynote sessions were fascinating too. There was a spirited discussion of how the healthcare reform will impact the drug industry from former Senate Majority Leader, Tom Daschle. Über-brain Chris Anderson, the editor of Wired magazine, discussed a cutting edge statistical theory called “The Long-Tail” and how it applies to the pharma world. And we also heard an emotional and human story of real courage and inspiration from Survivor show winner(the irony was not lost) and cancer survivor, Ethan Zohn.

It truly was an amazing three days in Orlando. The drug industry is doing incredible things, facing big challenges and hurtling towards an exciting future. And I'm glad, in our small way, that we're along for the ride. Over and out.



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.
 
 

China's State Food and Drug Administration (SFDA) has announced the opening a new center aimed at standardizing and streamlining the country's medical device standards process.

The new center will focus on developing standards for medical devices, organizing relevant committees to promote medical device manufacturing standardization, and developing standards for instruments. Other plans include possible improvements to medical device naming, classification, and medical coding.

Medical device manufacturers are certain to appreciate any help in managing China's 180 national standards and 727 industrial standards pertaining to medical devices!


ForeignExchange Translations provides specialized medical translation services to medical device companies - in Chinese and dozens of other languages. Contact us to find out why our clients rave about us!
 
 

Medical device and IVD manufacturers are subject to a veritable alphabet soup of quality standards. In an effort to align themselves closer with their clients, medical translation companies are assessing the pros and cons of expanding their own certifications.

After ISO 9001, the certification that is most requested is for ISO 13485:2003, the quality management standard designed for medical device companies and their critical suppliers. In response, we have updated ForeignExchange's quality system to be fully compatible with ISO 13485.

And last week, we successfully completed our first ISO 13485 audit. Some of the findings from the two-day audit highlight key strengths in ForeignExchange's approach to providing quality translation services, including:

• Exceeding on delivery deadlines
• Paid training for some employees demonstrated
• ForeignExchange's comprehensive client satisfaction survey
• Excellent data gathering throughout the organization
• Strong commitment to an effective QMS

We are excited about this important step. In combination with our existing ISO 9001:2008 [PDF link] and EN 15038:2006 certifications, adding ISO 13485 demonstrates ForeignExchange's wish to make it as easy as possible for device companies to work with us.

One big factor in this is that incoming inspection is less burdensome if a supplier is certified to ISO 13485. While ISO 9001 is focused on continuous improvement, ISO 13485 aims to "get it right from the start". And that makes ISO 13485 very relevant for medical translation service providers.


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

PDF files are omnipresent in today's medical translation world. Medical device and pharmaceutical companies use them for print proofs, CMC documents, patient reports, exhibits in regulatory submissions, and many other things. Medical translators are used to receiving files in the universal PDF format, and use OCR to streamline the translation of "dirty" PDFs.

The downside of PDFs is that, well, just about everybody can view, edit, and manipulate them. IN response, we have seen a steady increase in clients who password-protect their PDF files, trying to limit the distribution of their confidential documents.

The security of PDF files may not be all that strong [PDF link] but the bigger challenge for medical translation service providers and clients is removing passwords from dozens or even hundreds of PDF files.

Adobe's own Acrobat for Life Sciences blog has just posted step-by-step instructions on how to do this. Removing Security from PDFs: Individually and in Batch outlines how to check on the security used and create a batch sequence to remove security from multiple files.

There are some limitations to their approach and confusion is sure to surround the use of different levels of passwords permitted by Acrobat. But for drug and device companies that can agree on standard processes with their medical translation service providers, this is a nice time-saver.


Are you on Twitter? Follow us at @fxtrans.
 
 

Day three at the Partnerships in Clinical Trials conference started with a well-attended session that served as a case study about strategic partnership between a company and a vendor. In this case, it was a sponsor and a CRO but there are lessons in here that could apply to the translation world and beyond.

In 2009, Otsuka Pharmaceuticals, after a thorough CRO selection process, established a strategic partnership with Covance. The intention of the partnership was to move beyond a traditional tactical vendor/sponsor relationship and become a true collaboration of partners. David Zuckerman of Customized Improvement Strategies, Rick Cimino of Covance and William Carson of Otsuka, talked this morning about how the collaboration is working after its first year.

Mr. Zuckerman started with a brief introduction of why Otsuka chose to strategically outsource. First of all, they needed cleaner data and faster time to market. Also, with a larger pool of people there are more opportunities to develop drugs and there is broader expertise and increased flexibility.

Otsuka selected Covance based on cultural fit and a collaboration based on vision and strategy. The change was managed by both companies but they chose to have a third party facilitate the partnership. The transition of work from tactical providers to Covance took place gradually over time. Relationship managers were put in place at key points. Goals were seamless integration, and good, clean auditable data.

So how did it go? In 2009, multiple projects were started, cycle times reduced, processes were harmonized and integrated and best practices developed. Joint pipeline planning was also initiated and governance was integrated. For the future, in 2010 the goal is to be a breakthrough year and 2011 will be to extend and consolidate.

Mr. Cimino and Mr. Carson discussed what was attractive to each company about the other. Core values that were shared between companies were a major factor in the compatibility. Mr. Carson said that in the selection process, several of the CROs in the running did not take the RFI seriously and did not tailor responses to the specific scenario. Mr. Cimino said that while Otsuka was screening partner CROs, Covance also had to determine whether the fit was right for them.

Both men talked about how this collaboration differed from others their companies have had in the past. One major difference cited by Mr. Cimino was the speed with which the relationship took off and the extent to which knowledge was shared between the companies. Mr. Carson talked about the change within Otsuka, a traditionally conservative, private company, and how early the company was willing to get Covance involved in the discovery period of drug development.

Mr. Cimino and Mr. Carson finished by discussing the lessons learned and key goals for the collaboration in the near future.

[ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]


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.
 
 

Our recent post on future changes to the EU Clinical Trials Directive (2001/20/EC) had several readers inquire about the nature of these possible changes.

First things first: nothing has been decided yet.

Last fall, the European Commission DG Enterprise Pharmaceuticals unit released a public consultation paper [PDF link] on the assessment of the functioning of the EU Clinical Trials Directive. Stakeholders were invited to submit their responses by January 2010 deadline for submissions.

Industry then responded with its views of the current Directive. Here are two random examples from The Institute of Clinical Research [PDF link] and the Deutsche Gesellschaft für Hämatologie und Onkologie [PDF link].

As a next step, the Commission will consider these responses and either make amendments to the Directive or draft a new regulation to replace the Directive. More details should become available in the summer of 2010.

For more reading on clinical trials, take a look at these recent articles:

• Clinical trial agreement more important as research goes global
• Back translations - useful or waste of time?
• Insurance for international clinical trials
• Global clinical research - unethical or business necessity?

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

While a shrinking world presents new clinical trial opportunities to sponsor companies, the challenges of conducting trials globally that are approvable by regulators can be daunting. Ever-changing country-specific requirements can slow down trials. Should these different requirements affect country selection for trials? Does a sponsor need an in-country partner to help? How can you manage vendors around the world? A panel of experts addressed these issues Tuesday afternoon.

Graciela Racaro of PAREXEL presented some critical success factors to carrying out global trials:

• Carrying out a feasibility study before country selection
  
• Developing a study start-up strategy that takes into account country-specific issues
• Learn local regulations and what the critical path is to getting a study approved in a country
• Developing patient recruitment and retention strategies
  
• Logistical concerns (time zones, language)
• Establishing expectations for monitoring quality
• Development of a risk plan and mitigations

Larry Fiel of Boehringer Ingelheim encouraged sponsors to dig deeper when a CRO says they can manage trials in other countries. Ask questions about their facilities and staff and experience and capabilities. He also pointed out that regardless of where you're running a study, there are three areas a sponsor must pay attention to: data integrity, patient safety and regulatory compliance. Mr. Fiel also gave some further ideas:

• Plan ahead
• Appropriate and documented qualification assessment of vendors and CROs
• Use of Quality Agreements
• Build site and trial escalation processes upfront
• Conduct interim lessons learned meetings
• Coordinate for global inspection readiness
• Have an experienced trialist in each country and consider using a regional supervisor

Jacqueline Mardell presented some case studies demonstrating some of the challenges in global clinical trials. For example, in February in Russia, there was a halt to all clinical trials due to the absence of one official in the government who could sign off on approvals. Needless to say, this caused confusion and problems for sponsors and CROs alike. In another example, the patient data collection in a developing country ground to a halt due to a lack of infrastructure or mechanisms to track PROs from a largely illiterate patient population.

The key takeaways from this discussion really centered on planning ahead, utilizing local resources and experienced partners and doing homework on country-specific regulations.

[ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]


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.
 
 

A panel of CEOs from three major CROs met to discuss the topic of how to achieve the balance between mitigating risk while preserving profit margins and the state and future of the CRO industry.

Peter Gray of ICON led off by saying that the future of the CRO industry looks bright despite a bleak previous year and a half. He said the market is solidifying, becoming more strategic and there are more significant opportunities. RFPs are on the rise and the volume of opportunities is on the rise, particularly in Phase I activities.

Jeffrey McMullen of PharmaNet took the mic and reiterated that the CRO market is looking “bullish.” PharmaNet, which recently became a private company, focuses on late stage trials, early stage trials and high end generics. Cancellations have decreased as the economy is improving, which is a good sign. An increase in biotech funding is being seen in an increase in late stage trials and should trickle down to earlier stages as well. He mentioned that he is seeing a new model of outsourcing, with sponsors seeking more strategic relationships with CROs.

Daniel Perlman, CEO of RPS spoke third and cited the success of his company despite the gloomy economy. He attributes the positive growth to the rise in embedded solutions. Perlman sees a positive future for the CRO industry, with pharma companies decreasing fixed cost spending and seeking more outsourcing and embedded solutions.

Moderator David Windley of Jefferies asked where the growth will come from geographically, in the CRO business. Mr. Perlman opined that major growth will be outside the US – Asia in particular, Latin America and Eastern Europe. Mr. McMullen chimed in saying there is an underutilization of the patient population in the U.S., given the great institutions and large number of underserved patients in this country.

Mr. Gray felt that the decline in trials in the US is due to the rush to include Asia and other parts of the world at the expense of the US. But Mr. Gray cautioned that regulators will be more wary of the quality of data coming from Asian and Latin American trials. However, the lifestyles of patient populations in emerging markets can have as much of an impact of trials as ethnicity on trial results, which makes for an interesting issued to consider. Mr. Gray argued that trial data coming out of Eastern Europe is arguably better than that in the US, due to an increased motivation for investigators to bring trials to their countries.

[ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]


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.
 
 

It's day two at the Partnerships in Clinical Trials conference. This morning saw an interesting keynote session on the impact of a major acquisition in the pharmaceutical world.

In May of 2008, the Japanese pharma giant Takeda acquired American firm Millennium Pharma in a nine billion dollar deal. While it was a bold move for the company, Takeda had an ambitious plan to use the acquisition to push for leadership in cancer treatment. Two years on from the acquisition, we heard this morning from Nancy Simonian, Millennium's Chief Medical Officer and Senior VP of Clinical, Medical and Regulatory Affairs.

Ms. Simonian started out her talk with an overview of Millennium – a small, relatively young, company based in Cambridge, Massachusetts. Takeda's desire in acquiring Millennium was to make it an anchor company, with fully integrated R&D that was established in oncology. The challenge was to incorporate the company into Takeda while maintaining its small company culture and innovative, science-driven spirit.

Takeda set up Millennium as an autonomous business unit. Immediately after acquisition, Millennium went from having to handle four molecules to 14, a growth that would require a new way to do business. This new way meant smart outsourcing to introduce scalability in conducting clinical trials. It required Millennium to examine what it wanted to maintain in-house and what they wanted to commit to the CRO-partners – a re-mapping across the value chain. It was decided to shift internal focus to innovative activities and to outsource standardized work.

In the process of establishing a sourcing vision, the company used surveys to determine goals. They decided to use a small core team to drive competitive advantage while partnering with full-service CROs that could take the load off of internal Millennium staff. This shift was met with initial hesitation but was mitigated through training. Rather than lay off employees, Millennium trained staff to oversee processes rather than strictly doing the work, a smarter way to leverage the company's intellectual capital.

Meanwhile, an analysis of how many CROs were needed led to the conclusion to select three full-service CROs in addition to using some functional service providers. For the future, Millennium is working to refine processes, establish metrics and closely partner with its selected CROs to build long-term collaborations.

While it is still early days in the transformation, Ms. Simonian is confident that the steps they've taken and the road map they have laid out will lead to Takeda's goal of being a top oncology company by the year 2020.

ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]


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.
 
 

Back in 2009, pharmacy chains in New York City agreed to offer translated medicine labels to customers speaking one of the seven top foreign languages spoken in the city. While the city's pharmacies have been complying with the law, they may be putting non-English-speaking patients at risk.

It turns out that machine translation programs used by Big Apple pharmacies frequently make mistakes when translating prescription labels from English to Spanish. Some of these errors could put patient safety at risk, according to a study published in the May edition of Pediatrics.

Researchers surveyed several pharmacies in New York City (44 percent of the city's population speaks Spanish) that use computer programs to translate prescription information into Spanish.

The study found that about 50% of Spanish labels surveyed contained errors. The mistakes range from the benign (misspellings and mixtures of English and Spanish) to major errors which could pose safety risks if patients misinterpreted the information.

The researchers recommended that software companies design better translation programs to improve patient safety. In the interim, the authors advised non-English-speakers to ask for the help of a professional linguist. Good but impractical advice...

[Tip of the hat to Ashleigh Grange!]


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

It's day one at the Partnerships in Clinical Trials conference. I attended an interesting workshop this afternoon on CRO selection and the RFP process. I was struck at the similarities between CRO and translation vendor selection... Here's a quick summary:

In the outsourcing environment prevalent in the pharma industry, selecting a component Contract Research Organization (CRO) is crucial. The RFP process is the most common way to find a suitable partner that fits. But the outcome of an RFP is only as good as what goes into it. This was the topic of the afternoon workshop titled, "Provider Selection and the Request for Proposal Process."

The speakers walked us through the main steps, best practices and most common failure points of RFPs. As with most things, good upfront preparation pays big dividends. Determining strategy (Why outsource? Who? How?), interviewing internal stakeholders and making sure the strategy aligns with your business model are key. Also, being honest about your company’s core competencies will help decide whom you should partner with to fill in the holes.

The actual selection process begins with the Request for Information (RFI) to gather enough information to pare down to a short list of providers. It should identify key criteria for selection, probe for information beyond sales speak, utilize open communication throughout the process and be graded with a weighted scorecard for optimal results. The short list that comes out of this RFI will be a list of a handful of companies that will then respond to the more detailed RFP for a specific study.

Clinical study RFPs are often riddled with inconsistencies and errors which can tilt the playing field and hamper an accurate analysis of responses. Table format is easiest to collect succinct, focused responses in an easily-analyzed fashion. Roles and responsibilities must be sharply defined. Working collaboratively with the responding CROs in the RFP process sets the stage for a future relationship. Remember, one of these companies will be trusted with your company's product and future. So move past the vendor selection mindset and towards a more transformative partner development. Starting with a good RFP is a great place to begin.

[ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]

For further reading on how to develop effective RFPs, take a look at Developing an RFP? 7 tips for getting the responses you want.


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.
 
 

The Partnerships in Clinical Trials conference opened today in Orlando with a series of workshops. I attended a fascinating one this morning that discussed the impact of virtual workforces in our modern world.

According to a recent study, 75% of the workforce will be virtual by 2012, "virtual" referring to those who work remotely, relying predominantly on electronic communication technology. More and more companies, particularly pharma companies, are turning to outsourcing and dispersed workforces to maximize efficiency, coverage and cost-effectiveness. While the advantages of PDAs, Bluetooth, social media and VPNs are obvious, the irony is, the more connected we become, the more isolated we are. This is the connectivity paradox described by Karen Sobel Lojeski in this morning’s workshop, "Workforce Transformation: Leading Effective Cross-functional Teams in a Matrix Environment."

Trying to fit a 21st century style of working into a 20th century model creates what is called vertical distance, a perceived distance when electronic communications are relied on. Context is lost and a lack of "depth perception" can result in a decline in critical outcomes, job satisfaction, role clarity and a host of other areas. The three key factors that influence virtual distance are physical distance (geography, time zones), operational distance (technology, employee distribution) and affinity distance (culture, relationships and interdependence).

Mitigating as many of these factors can diminish the overall negative impact of virtual distance. This means knowing when to have face-to-face meetings, upgrading communications technology to accommodate video, phone and Web conferencing, flattening hierarchies and making sure values are aligned across all company cultures.

Sobel Lojeski's co-presenter, Solomon Babani, showed how his company, Celtic Pharma, has applied the lessons of virtual workforce so it works to their advantage. Rather than force a traditional business model to a virtual work environment, the company was built from the ground up on an outsourcing model. De-centralizing the planning and oversight and accountability and distributing it among a network of sub-suppliers, such as CROs, it effectively engages all parties and leverages their true core competencies.

As 21st business moves towards the inevitable – virtual workforces – an understanding of virtual distance factors and effective ways to mitigate them will be key to survival in this brave new world.

[ForeignExchange covers the Partnerships in Clinical Trials conference in detail. Check out our comprehensive coverage.]


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.
 
 

IEC 60601-1 sets general requirements for basic safety and essential performance of medical electrical equipment. The third edition of the complex standard sees major changes from the second edition. While Canada, Europe, and the U.S. are in various stages of implementing the IEC standard, there is some progress towards harmonization.

Eisner Safety Consultants recently reported on a piece published in FDA News Devices & Diagnostic Letter. "US Devicemakers Given Three Year Transition to IEC 60601-1" reports that CDRH has adopted the international standard last month.

Why the relatively long three-year transition? One reason would be the scope of changes: The third edition includes a whopping 114 subclauses that are not contained in the second edition.

For more information on IEC 60601-1 3rd Edition, take a look at:

• Regulatory strategies for IEC 60601
• Eisner Safety Consultants' blog
• How to Mark & Label Devices Under IEC60601-1 3rd Edition

Follow us on Twitter at @fxtrans to get your daily dose of multilingual compliance news.
 
 

Another month's worth of presentations are in the virtual "can". Our partnership with the Society of Quality Assurance has produced some great events. More are in store for the next couple of months - check out the upcoming audio conferences at www.fxconferences.com.

Here are the top five events for March:

1. QA Oversight of Vendor Management


2. Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting


3. Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?


4. Outsourcing and Offshoring in a New Era of FDA Enforcement


5. Medical Device Vigilance Planning under the Revised MDD

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

Interested in other popular educational events? Take a look at our top audio conferences for February and January.


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

One of the blogs that I enjoy reading is Pete Abilla's shmula. His posts touch on everything from Lean manufacturing to word-of-mouth marketing to Six Sigma. But his main interest lies in the area of operational research known as queuing theory.

What's really cool is that Pete is able to make a mathematical and potentially dry topic fun and relevant to different people. Today's article on waste in the adoption process is a terrific example.

As I was reading his post, two things occurred to me about our business:

1. Absolutely anything can be analyzed, measured, and tracked. If you don't believe me, just take a look at Pete's analyses of oil changes, Build-A-Bear stores, and college basketball.
2. Translation companies that hide behind "you can't measure our work - translation is an art, not a science" have no business being in the medical translation business. Drug and device companies devote huge resources to understanding and improving their processes - including translation.

For medical translation service providers that "get it", this presents an opportunity to improve their project management approaches, streamline their operations processes, and trounce the competition.


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

Starting next Monday, I'll be blogging my way through the Partnerships in Clinical Trials Conference in Orlando, Florida. The three-day conference is a gathering of leading companies and thinkers in the clinical outsourcing field, from the drug industry to academics, from a former Senate Majority Leader to a reality TV show winner. How does it all fit together? I'm eager to find out.

I'll have my laptop handy and will be blogging daily about the scene at the conference and the sessions I'm attending. I'll post blog entries here on Medical Translation Insight as well as on the official Partnerships blog.

If you happen to be going to Orlando for the conference, drop me a line at jheaton [at] fxtrans.com so we can meet up. Or, if you're stuck at the office, you can tune in here daily to read what's going on in sunny Florida.

You can check out the conference's official Website here.

-written by Jason Heaton, ForeignExchange marketing manager

Translation service providers deal with people from around the world. Much of the time, contact is through email. When it comes time to have a phone conversation, it sure helps to know how to pronounce the other person's name.

I know first-hand what it's like to have folks mispronounce your name. But hey, that's just the way it is; I don't expect perfect pronunciation the first time someone meets me but I'm pretty impressed when it happens.

Lifehacker reports on three name-pronunciation resources that make it a lot easier to impress your clients and partners with the proper pronunciation of their names.

HearNames.com lets users search for someone's name in two ways, through the search field or by manually clicking through sub-sets of nationalities and languages. Once you click a name, you'll get an embedded (Flash) audio player, with a human voice reciting the name correctly.

Voice of America provides a pronunciation guide for places and famous people. It's limited to what appears in VOA news coverage but contains names not found at HearNames.com.

Pronounce Names is yet another resource that allows you to look up the pronunciation of a name. What's cool about this site is that users can submit pronunciations of new names so that others can then pronounce it correctly.

So go ahead and play around with these three sites. That way, you can avoid mangling, twisting, and contorting any more names.


OK, back to work now! ForeignExchange Translations provides specialized medical translation and software localization services to pharmaceutical and medical device companies. Contact us to learn more.
 
 

When executives at medical device manufacturers think about the opportunities in Asia, they are bound to get giddy. Just look at some of these facts, reported in Asian Hospital & Healthcare Management:

• Asia has 60% of the world population but only 15% of global healthcare expenditure.
• Healthcare expenditures are growing at an annual rate of 6.2% across Asia.
• Some parts of Asia are experiencing high population growth, while other countries are faced with rapidly ageing populations, as shown here:

With all of these opportunities presenting themselves, it is no wonder that device companies (and drug companies and any other company selling to the healthcare sector) are paying close attention to new and changing regulations that might influence how they can promote their products.

Because where there are opportunities, there are risks. Here is a statement from a typical 10-Q report:

Compliance with the extensive government regulations to which we are subject is expensive and time consuming, and may result in the delay or cancellation of product sales, introductions or modifications.

And:

Extensive industry regulation has had, and will continue to have, a significant impact on our business ... [D]omestic and foreign statutes and regulations govern or influence the research, testing, manufacturing, packing, labeling, storing, record keeping, safety, effectiveness, approval, advertising, promotion, sale and distribution of our products.

The current issue of RAPS Focus has a good article on the latest Advertising and Promotion Policies in China, Japan and Singapore [login required]. The article presents a good overview of the general rules in these three major markets.

In China, manufacturers must take care that certain claims are not included in advertisements. Here is just a sampling:

• guarantee of effectiveness
• efficacy or recovery rates
• safety of effectiveness comparisons with other devices
• nonscientific description of the device's performance characteristics

For medical translators, these rules are important to know about as well: Certain words, such as "safe", "no side effects", "refund if ineffective", "only", "exact", and even "fills a product gap in China" are a big no-no.

On the other hand, certain disclaimers (in Chinese) must be included. As an example, "Contraindications and cautions are specified in the product manual." must be featured in the advertisement, as applicable. For international marketing managers and translation service providers alike, this means that advertisements destined for China can't "just" be translated but must be localized and adapted.

If you are involved in producing Chinese-language advertising materials for medical devices, it pays to understand these guidelines!


ForeignExchange provides specialized medical translation and localization services to medical device companies - in Chinese and 40+ other languages. For your next international marketing campaign, ask for a detailed proposal.
 
 

Spring is here! And with it, hopefully, more sunshine.

Aside from the wet, wet weather, March has been a terrific month for us. We are in full "growth mode" at ForeignExchange. We are winning new business, are expanding our team, and are publishing more newsletter and blog content than ever.

So, without further ado, here are the five most-read articles in March:

1. 3 things no one told you about working from home - Ashley Jones' article on working from home hit a nerve
2. Language fact: Norwegian - Witness the power of social media: After making it's way onto Stumble Upon, this article gets a second life
3. 10 reasons why English is so difficult to translate - Go ahead and see how much fun disruptive it is to turn nouns into verbs or combine nouns ad nauseum
4. Social media and the translation business, revisited - And speaking of social media, our update on the topic proved popular
5. Language requirements for the new MDD - For medical device manufacturers, the revisions to the MDD loomed large in March

Looking for more great content? Take a look at our top articles for February, January, and December. Happy reading!

As we noted a couple of days ago, successful device and drug companies don't just view packaging as the minimum effort to sell products overseas. Instead, they look to packaging and labeling to support the company's identity and brand: The package is the hands-on manifestation of the brand.

Becton, Dickinson is an example of a company that understands this. BD has developed extensive support materials including, for example, a brand standards overview [PDF link] and a multilingual symbols glossary [PDF link].

These documents are available online and provide employees, partners, and suppliers with an understanding of the BD "look and feel", of the symbols that BD uses and how they are used.

While it is a big job to put these resources together, having this kind of marketing input is invaluable. It allows labeling, packaging, and translation groups to work better and faster - all while achieving the company's marketing objectives. Now that's what you call a win-win!


ForeignExchange translates medical device and pharmaceutical packaging and labeling materials into dozens of languages. Ask us for a detailed proposal on your next medical translation assignment.