Posted by Lionbridge Blogger on Mon, Aug 23, 2010 @ 01:59 PM
Mozart was only 4 years old when he composed his first piece of music; by age 9, he had composed his first symphony. At such a young age, Mozart already understood how to create brilliance by bringing together his talents in perfect harmony. Unfortunately, Mozart did not live beyond age 35, but his extensive works count toward the most precious in the history of classical music.
You are probably thinking: Interesting, but what does this have to do with Life Sciences localization? Metaphorically a lot ……. I will try to explain.
Prior to my linguistic studies in Interpretation in Brussels, I had the privilege of attending the conservatory of Liege in Belgium, where I studied classical piano. From day one, I was intrigued by Mozart’s symphonies. I listened to all of them, driving my family members crazy.
I have been working in Life Sciences localization for over 10 years, but it was only recently that I realized that Mozart’s symphonies are actually musical metaphors for what we, as account managers in Life Sciences localization, do on a daily basis. You are probably thinking now: Interesting, but I still do not understand ….
Well, for starters, whenever I need to work on a Life Sciences Request for Information (RFI) or Request for Proposal (RFP), for example, I create the perfect working environment. This means, I put on my headset, select the appropriate music — usually Mozart — put the “Do not disturb” sign on the door of my home office, and totally isolate myself from my surroundings. May I ask you to join me in putting on your headset and clicking:
before you continue reading?
You will hear the Linz Symphony of Mozart. No. 36 Presto, conducted by one of the greatest conductors of all times, Herbert von Karajan. If you listen very carefully, you will hear more than just a symphony. You will hear that the conductor is coordinating the performance of all the different, very talented musicians in his Berlin Philharmonic Orchestra. He is making sure the contributions of the cellists, violinists, clarinetists and those playing double basses are tuned and in perfect alignment and harmony.
If you extend this thought to how we develop new localization business for Life Sciences, account managers too must manage and coordinate the performance of the different, talented stakeholders involved with RFIs and RFPs. They must ensure that the contributions of the Solution Architects, along with their colleagues in Operations, Quality, Finance and Legal, are also tuned and in perfect alignment. The account manager (acting as the conductor) is responsible for merging the output of all the different talents into one unbeatable deliverable that will blow away the audience — the potential customer.
Complicating the account manager’s job are the unique aspects of the Life Sciences sector, with its very specific sets of requirements. Since regulations are constantly changing and a premium is placed on quality above all else, dealing with localization in this highly-regulated industry means the account manager faces extra layers of complexity.
So in writing this blog post today, I’m hoping to do two things: I want to pay humble tribute to the dedicated conductors, cellists, violinists, clarinetists and other musicians who share their talents with us and demonstrate team spirit and joint commitment through their work. And secondly, I want to remind localization professionals that success lies in each of us; but it can only fully blossom when we work together, in perfect harmony. Or, should I say, in perfect symphony...
Posted by Lionbridge Blogger on Thu, Aug 12, 2010 @ 12:31 PM
Although barcodes are not translated (since they are universal in their use), they are typically located on every translated label or product manual. Eventually, your language service provider will need to know a thing or two about how they are set up, created and maintained to help you with your labeling projects.
Currently, the majority of medical device manufacturers use the HIBC (Health Industry Bar Code) standard for their products. HIBC was created for the unique health care industry because the requirements for tracking products in this environment differ from consumer products. Labels for patient use must be as error-free as possible, and must contain certain specific information. HIBC has been a reliable method to create barcodes and track products, but the emergence of another organization is challenging this mature standard.
GS1 is an international, non-profit association that develops and implements global standards and solutions to improve supply chain management for all sectors. It is currently the most widely-used supply chain standards system in the world, and is a consolidation of the work of the North American UCC (Uniform Code Council) and the EAN (European Article Numbering Association). GS1 offices are located in over 100 countries around the world. GS1 Healthcare is a global user group that brings together key stakeholders to evaluate and standardize the implementation of GS1 within the health care sector. For more information on GS1 Healthcare, go to www.gs1.org/healthcare.
GS1 developed the GTIN, or Global Trade Item Number, as the identification number on a product. The GTIN is equivalent to the HIBC manufacturer number plus a unique product identifier. The number is comprised of both static and variable data that together make up the UDI. For more specific information on the structure of the GS1 numbers, go to www.gs1.org.
Recently, a significant number of organizations that support hospital purchasing and supply chain management have asked that suppliers use GS1 locator numbers on products by the end of 2010, and the trade item numbers by the end of 2012. GS1 barcodes are also being requested of medical device manufacturers from countries around the world such as Germany, France, Turkey, Chile, India, and Japan. The United States is the first to adopt the standard, and representatives from the EU are participating in the US implementation to ensure EU issues are addressed.
There is lively and contentious debate on the move from HIBC to GS1. It may take time for both internal manufacturing sites and external customer sites to adjust their systems to read the new GS1 barcode. That could mean that, for a time, labels need to be updated with TWO barcodes to allow for the transition from one standard to another. Regardless of the point of view, one thing is clear…the bar coding fun for labeling and supply chain professionals is far from over!
So if you are on the labeling team in a medical device or pharmaceutical manufacturer and you have NOT heard of GS1, give your supply chain group a call to find out your particular company’s approach. If you are a language service provider and provide updates for product labeling, understanding your client’s approach to the barcode is critical. As stated above, even though the barcode itself does not have a translated component, it is on every translated label. Therefore, your clients will most likely be updating and testing new labels with translated content.
For more information on the use and application of GS1, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/default.htm
For an overview of what medical device and pharmaceutical companies need to address during this conversion, see
http://www.rxtrace.com/2010/03/so-a-customer-demands-that-you-use-glns-and-gtins-what-next.html#more-164
Posted by Lionbridge Blogger on Tue, Jun 22, 2010 @ 01:03 PM
During a recent discussion regarding CMS implementations, I was shown a very simple graphic depicting the conceptual utopia of simultaneous content creation, review, edit, release, and translation workflows using XML topics. This is the baseline premise of XML systems; that you can author in smaller topics, review in smaller topics, translate in smaller topics, and the CMS system manages these topics through a symphonic workflow and produces content topics that fit together in perfect harmony.
For anyone who has attempted, is attempting, or has abandoned an XML implementation in a Life Sciences environment, simultaneous development and review of content is an ideal future state. However, showing such a slide to those new to the process without proper context or explanation is irresponsible. This future state may take years to achieve, and setting unrealistic expectations in the very beginning stages of CMS system evaluations is risky. Implementing an XML-based CMS solution for Life Sciences clients is complicated and has specialized issues that need to be addressed in a responsible and pragmatic manner. If you are a medical device or pharmaceutical client looking to implement this type of solution, here are some key considerations as you embark on finding the right partner:
1. Ensure the partner you are engaging with understands the complexities of your environment - Simultaneous content creation, review, and translation within a well defined workflow are conceptually possible. However, implementing these capabilities within a highly-regulated environment has specific concerns that need to be addressed prior to selecting a technology solution. Be sure the partner has someone on staff who can answer specific questions regarding authoring in the Life Sciences industry.
2. Find a partner who understands it is about process, not technology - Anyone who comes into your company for a discovery meeting and does not discuss the content development process is unaware of the challenges of a successful XML implementation. Knowing how to move from the current condition to a future state is critical.
3. Ask for references - One of the first questions to ask your partner is to point to a successful implementation within an environment that mimics your own. Seeing a successful process at a software company authoring department doesn't quite help you if you author for medical devices. And since there are few Life Sciences companies working in a fully deployed XML environment, you will most likely be a trailblazer. Just be sure you have access to someone who can address your specific concerns.
Posted by Lionbridge Blogger on Mon, May 17, 2010 @ 12:37 PM
This week, a well known CRO client of ours contacted our Clinical Trial Translation Department to get a rough estimate on translation for a trial they were bidding on. The client outlined, in broad terms, the size of the documents (protocols, ICFs, etc.) they were expecting to receive from the Sponsor. Our team was given expected sizes and delivery date estimates and was able to produce a working estimate for the bid. Pretty straightforward stuff, but I was curious as to why the change from the norm of receiving the finalized documents and then sending them to us for a quote and execution of translation.
I decided to call up the client to get some feedback. His response made perfect sense to me! "In the past we have just estimated the cost of translation," he said. "Often, we were in or around the actual final cost, but it's where we have grossly underestimated the cost that it becomes a problem." He went on to say, "If we have to go back to a Sponsor and inform them that some part, any part, of the costings are inaccurate and we need more budget, one of two things can happen: 1) the Sponsor is ok with that (very rare), or 2) they tell us to eat the extra cost because that is what they signed up for! That impacts directly on our bottom line!"
Based on my own experience, I would have guessed the latter response to be more typical. Why wouldn't the Sponsor say that? It wasn't their error! Our client went on to say, "Not only can it jeopardize the entire bid for the trial, it makes us look less than professional if we can't get our estimates right in the first place." Once again I couldn't disagree with him. He concluded by telling me, "So we've learned the hard way that by making a few calls early on in the process, we can remove any of those awkward moments and focus on the real issue at hand....winning our bid!"
In truth, he was making a lot of sense to me. If we were to bid on a translation project and we underestimated the cost badly, it would be with more than a little trepidation that we would go back to the client and explain, "Sorry we made a boo-boo!" The client would rightly look at us skeptically and wonder if they had made the right decision in awarding the translation project to us.
I suppose the motto of the story is, "If you fail to plan; you plan to fail!" I hate clichés, but when it's true....it's true. Making a simple phone call early in the process can avoid awkward conversations with Sponsors about getting more budget.....not to mention saving face!
Posted by Lionbridge Blogger on Mon, Apr 26, 2010 @ 12:58 PM
For those of you familiar with validated instruments and the translation process for them, I apologize if this is all too familiar to you. In order to explain the new changes, it is important to understand where we were before DIA Annual European Congress in April 2010.
In a typical validated translation, as per the ISPOR Guidelines on translating validated instruments, a validated instrument passes through some stressful translation methodologies, i.e., 2 X Forward translations, 1X Back translation, reconciliation, Harmonization and critically Cognitive Debriefing before a proof reading and formatting so that it is in its distinctive rendering.
It is the Cognitive Debriefing (CD) portion that has had some debate over the past few years. Indeed, I have written a number of times about this issue - i.e., Do we carry out CD with patients in the targeted disease state, or can we use candidates that are representative, both culturally and socio-economically?
There have always been two schools of choice here: the purists maintain that patients in the disease state have differing perceptions of questions than those in a healthy state. Specifically, the argument has centered on oncology patients who have very different perceptions of tiredness, fatigue, and lethargy. It is in that differing perception that some believe we can distill more valuable feedback during the CD process.
Then, there are those who maintain that because the CD participants are not actually "answering" the questionnaire, and that all they are providing is feedback on the instrument's readability and understanding, it renders the former argument moot.
I, for one, have always seen merits in both arguments; and, as one who is zealously committed to augmenting the translation process, I was probably leaning toward performing the CD with patients in the disease state. If nothing else, we would be using live data rather than representation data, if you will.
This argument was finally put to rest at the above-mentioned Congress, when, during the Regulatory Track, the FDA said it "expects" CD to be carried out with patients in the disease state. There were some gasps in the room because of the sheer length of this debate. For those of you in Life Sciences long enough, you already know that "expect" is FDA speak for "This is how we want it done!"
So, why and how does this change the world for Pharmas and CROs alike? Well, typically, translation companies have legacy in one form or another of recruiting clinical translators. Some have deeper legacy and quality than others (but that argument is for another day). The "new" challenge for translation companies is how to recruit patients in that particular disease state. I cannot overemphasize the challenge this will be to almost all translation companies due to:
- Their lack of experience in such a task, AND
- The fact that most translation companies do not have a physical presence in emerging markets to recruit such patients and mental health personnel to perform the interviews.
As I have written about before, many, if not most, translation companies outsource translation to local, in-market translation companies without the Sponsor even knowing. The Sponsor's intellectual property is shared with third- and fourth-parties, and now these smaller in-market translation companies will be expected to recruit patients in a particular disease state?? Remember, these smaller third- and fourth-party translation companies do not have to abide by the rigorous SOPs that the primary translation company must abide by. How do you govern a translation methodology that is now very complex when a) you do not have a physical presence there, and b) they are not direct employees? I can't see it done, I'm afraid.
In this new world where the CD portion of a validated, translated instrument MUST be performed with patients in the targeted disease state, it will be incumbent on the Sponsors and the CROs to ensure they leverage a translation company with the following:
- A physical presence in or near the target market
- Experience and know-how to recruit patients in the specified disease state
Posted by Lionbridge Blogger on Thu, Feb 11, 2010 @ 04:13 PM
Mark Wade, Global Practice Leader of Lionbridge Life Sciences, recently wrote about language translation within the area of global clinical trials in the Life Science Leader "2010 Guide to Outsourcing Partners."
In addition to discussing the role translation plays in clinical trials, Mark also provides three best practices which will help ensure success in your clinical trial:
- Plan for Language
- Look for a Local Presence
- Audit the Managing Translation Site
Learn more using the following links:
Posted by Lionbridge Blogger on Thu, Jan 07, 2010 @ 08:30 AM
Today Mark Wade is sharing his opinions on why Cognitive Debriefing subjects don't need to be in the specified trial disease state.
Recently I've had some discussions with a Sponsor about whether Cognitive Debriefing subjects need to be in the specified trial disease state. Can we use healthy, non-disease state interviewees in this process?
Cognitive Debriefing (CD), also known as Pilot Testing, is part of a translation process where people are invited to review a recently translated, validated Quality of Life (QoL) instrument - a questionnaire - that will be used in a clinical trial in their country. They review the questionnaire and are asked specific questions by a Debriefer as to whether the translation is both culturally and linguistically correct. They are specifically asked whether the verbiage in the questionnaire is clear and unambiguous. The review is carried out in a structured interview fashion.
It is well established that these subjects must be based in the country where the trial is taking place; they should represent the trial's characteristics in terms of race, gender and socio-economic backgrounds. A debate continues, however, as to whether these interviewees should also have the disease pathology specified by the trial.
In 2007, a paper submitted to ISPOR spoke to this very topic. Entitled 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, the article concluded that, where possible, patients in the disease state should be used. The language was, I would respectfully suggest, deliberately open. Recruiting people in certain disease states is almost impossible. Chronic Obstructive Pulmonary Disease (COPD) is a good example. It is extremely difficult to recruit people in the chronic disease state, so authors and instrument developers have become creative and recruited patients with emphysema and other respiratory conditions. I am quite sure it has been considered that recruiting certain patients with advanced forms of cancer to review the translations is improper, given that their participation neither promises the prospect of therapy nor the promise of good health. It is just a linguistic validation exercise.
So, the real question is: If you use participants in the disease state, do you get better data from the group or not?
There is at least one relatively strong argument I have heard for using patients in the disease state: Patient experience is important for linguistic validation of the questionnaires. There are language-based differences in understanding expressions such as fatigue and lethargy that have different meanings to cancer and non-cancer patients.
The argument is that sufferers have a different understanding and concept of fatigue and lethargy than non-sufferers. I believe this to be true. I am sure there are many differences in the way sufferers perceive the world around them. I am sure that abstract and tangible concepts, such as time, hold different meaning for both groups of people.
But where I am at a loss is why that has anything to do with linguistically validating a QoL instrument. When we perform CD, we are looking to see whether the translation is culturally correct, linguistically correct, and clear about the information the instrument is trying to elicit from the patient. Given that the interviewees DO NOT actually ANSWER the questions in the instrument at the time of validation, I fail to see the advantage of solely recruiting people in a particular disease state. Taking up their time seems selfish to me. When we look to concepts such as fatigue or lethargy, we are asking whether the question is understood. I am sure that a healthy person and a sick person would answer it differently; but, we'll never know because we don't ask them to answer the question on the questionnaire. We only ask them if they understood the question.
Learn more about translation in the Life Sciences industry in the Lionbridge Knowledge Center:
Posted by Lionbridge Blogger on Tue, Sep 08, 2009 @ 01:47 PM
Today, our guest blogger Mark Wade talks about what is important in clinical trials...
Finally empirical evidence that turnaround times and deadlines are mission critical in clinical trials. A staggering 19 out of 21 pharmaceutical companies surveyed by Cutting Edge Information ranked a contract research organization's ability to hit trial deadlines as either "extremely important" or very "important," making it the top quality identified by respondents.
The report, titled: "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships" gathered data from a cross section of Pharma companies.
- Six were large, global pharmaceutical or biotech companies with multiple approved products and earnings of over $10bn dollars
- Five were medium-size companies with at least one approved product and earnings of over $1bn
- Five participants were small pharmaceutical companies without an approved product on the market
While the report notes that Pharma companies understand that there are unavoidable unforeseen delays possible in trials, it is the CROs 'real world' experience and ability to deal with these issues that sets some apart from others.
So what does that mean in terms of translation? Well, consider that each of the necessary documentation needs to pass at least once through an Independent Review Board (IRB) before the documents become final. If you also consider that CROs often receive several versions of the final documents from the Sponsor before they become final with very little time to spare before sites are supposed to go live, then the challenge for language translation becomes clear.
With a Sponsor focused on working closely with their CRO to ensure that documents are signed off and CROs focused on having sites prepared for the first day of patient enrolment, it is very easy to push language translation down the priority list. The problem with that is that if you do not have the patient facing documents translated, you cannot enrol your first patient!!!
It appears to me that it is becoming more important everyday to work hand-in-hand with the CROs and Sponsors to ensure that any translation that can be done upfront. The risk of leaving all translations until the last few days has too much of a risk profile i.e. no first enrolment...significant increase in non-recoverable costs!
Posted by Lionbridge Blogger on Tue, Aug 11, 2009 @ 07:00 AM
Today's Guest Blogger in our Life Sciences blog is Mark Wade, the Life Sciences Global Practice Leader at Lionbridge Life Sciences. He has more than 15 years of sales and operations management experience in the life sciences industry. Thanks for joining us, Mark - take it away!
Over the past few months there has been some unbelievable noise made about two large Pharmas outsourcing their respective R&D capabilities to CROs. There are no redundancies per se, but the CROs take on all of the R&D staff as their own and manage the whole discovery process, Phase I - IV etc.
Okay, I understand that; the old TCO model and all that, but isn't there a grey area around who owns the IP? On the premise that "you can't unlearn what you have already learned," can some of this IP cross-pollinate into other areas?
Wall Street values Pharma companies on what IP they have coming down the pipeline. If the CRO is effectively running this pipeline and the Pharma is paying for it, then is the 21st century Pharma just a brand and a sales channel?
The old cliché "Poacher turned Gamekeeper" springs to mind ... just a thought!
Posted by Lionbridge Blogger on Thu, Jul 16, 2009 @ 09:31 AM
Our first Life Sciences post comes to you from Kaarin Gordon, the Lionbridge VP of Life Sciences. Meet Kaarin and the rest of the Lionbridge bloggers on our About page.
It is interesting to watch the Pfizer evolution. Why I find this intriguing is because Pfizer is a legacy, large Pharma who has now acquired Wyeth, a large Pharma also, but one that already transformed itself into a Pharma AND Biologics company. This is a fundamental change both Pfizer and for the industry at large.
Think about it...now we are talking about creating individual pharmacological products based on individual patient's physiology. These individual medicines are the next evolutionary step in pharma. So what? It means a significant number of additional trials will be needed = a significant number of patients will be needed = AN INCREASED NUMBER OF LANGUAGES required.
There's another piece to this. As individual medicines emerge, the amount of content in Labeling (Notifying Body clinical submission) will increase exponentially. This is the due to the single patient specific scenario of biologics and Labels will have to incorporate all scenarios of patient physiology. Again, this means an increased amount of content will need to be translated.
Pfizer acquires Wyeth. Roche acquires Genentech. This is only the beginning...