ebook THE FIVE-STEP STRATEGY FOR QUALITY AND RISK-MANAGED LIFE SCIENCES TRANSLATIONS PAGE 1 library

Transcription

1 ebook library PAGE 1 THE FIVE-STEP STRATEGY FOR QUALITY AND RISK-MANAGED LIFE SCIENCES TRANSLATIONS

2 The Five-Step Strategy for Quality and Risk- Managed Life Sciences Translations Companies in the life sciences industry face a particularly difficult set of challenges in bringing products to the global marketplace, not least of which is delivering multilingual content. The importance of translating product information carefully and correctly cannot be overstated. As many companies can attest, errors in language translation can yield disastrous consequences, including patient injuries, product recalls, missed product launch dates, damage to their corporate brand, litigation and financial losses. Managing translation into one additional language is challenging enough but when multiplied across two, five or ten languages, the process can become cumbersome, expensive and risk-laden, particularly if it is not managed in a centralized manner. United Language Group has supported hundreds of life sciences companies with the translation, localization and formatting of product development, sales and marketing materials. The following tips, based on our 30 years of experience, will help you select the most suitable LSP for your needs and get the most from that partnership. ESTABLISHING BEST PRACTICES The world of global product marketing is more competitive and moving faster every day, with more companies entering the international sales arena than ever before. Advances in design-tomanufacture technology have led to shorter product development cycles and accelerated time-to-market. Not surprisingly, companies are seeking ways to expedite translations for product, regulatory and marketing documentation into multiple languages without sacrificing quality or increasing costs. Today, companies can reduce their risk and streamline the translation process by partnering with a qualified Language Services Provider (LSP) that offers the right combination of expertise, infrastructure and resources to meet their needs. To achieve this, look for a provider who offers the following: PAGE 2

3 1. Documented, internationally recognized quality and risk management standards 2. Content management system (CMS) support to streamline process development 3. High-quality, documented method for qualifying and managing vendors and resources 4. Web-based technology tools to foster efficiency 5. Multilingual rebranding expertise In addition, various auditing organizations are increasingly suggesting that their clients partner with outside vendors that have formal quality and risk management strategies. Some manufacturers have internal staff to monitor translation quality, but many must rely on their LSP to be their language quality expert. This is an acceptable trade-off, provided you choose an LSP with documented, proven quality and risk management practices. As you assess providers, consider the following: Does the LSP maintain certifications for key industry quality and risk standards? One way to ensure that your quality and risk management requirements are being met is to select an LSP with certification/ registration in the internationally accepted standards established by the International Standards Organization (ISO) that apply to your industry. 1. CHOOSE AN LSP WITH DOCUMENTED AND INTERNATIONALLY RECOGNIZED QUALITY AND RISK MANAGEMENT STANDARDS Companies today are increasingly aware of the need to expand their quality and risk management procedures beyond traditional product development, to include the process of translating product support materials. This is being driven from both a business and a regulatory perspective. Some companies are taking it upon themselves to include language translation in their overall quality and risk management strategy. Together, these certifications provide assurance that the most stringent process and quality standards for translation and desktop publishing are followed. Partnering with an LSP that maintains these certifications/registrations gives companies the assurance that the standards applied to their product development life cycle are just as stringently applied to their translations process. Is quality ingrained in all staff on the LSP team? How is this accomplished? Does the LSP have documented standard operating proceduers (SOPs)? Are they updated regularly? PAGE 3

4 Does the LSP conduct regular staff meetings to ensure that everyone is following these SOPs? If the LSP operates multiple sites, are they driven by the same quality procedures so that work can move seamlessly from one site to another as needed? Does the LSP open up their operations for client quality audits? How are these quality standards reflected in the services you receive as a client? These questions should help you identify strengths and weaknesses, whether you are assessing current practices or considering new providers. 2. FIND OUT HOW THE LSP QUALIFIES AND MANAGES ITS PROJECT MANAGERS AND TRANSLATORS When working with an LSP, your work will be managed by a team of project managers, linguists and desktop publishing specialists. Each of these team members plays a critical role in producing consistent, high-quality translated materials, according to your specifications, and making sure it happens as efficiently as possible. An important consideration in assessing the LSP is its experience in supporting clients in your industry. As experienced project managers know, life sciences translation projects carry additional requirements beyond traditional language translations. Project managers should understand the importance of accurate translations and document layout for the safety and performance of their client s products. They should know to never compromise where language and regulation converge. Clearly, the best results are achieved when everyone on the project team has prior experience working on related projects. Some LSPs can provide complete, specialized teams with years of experience. They also capture client-specific project handling preferences in a client database, ensuring the shortest possible learning curve for any new members who join the project team. Project manager qualifications The project manager plays a pivotal role in ensuring that you receive consistent, high-quality translations, on-time and within budget. For best results, your LSP should provide you with a project manager who has hands-on industry experience. For example, if your company specializes in pharmaceuticals, cardiology products or managing clinical trials, your translations will be best managed by a project manager who has worked in the industry as a translator or in a marketing, product or project management role and understands the critical aspects of language translation for your products. They will come into the project knowing which questions to ask and when to ask them, preventing any delays in final file delivery. PAGE 4

5 Additionally, the LSP should be able to provide translation services in all of the time zones that your product team requires. For example, if your product teams are located in the U.S.and Europe, your LSP should be able to address all translation needs for each location, in real time, without delays due to time zone differences. The best LSPs have established qualified project teams in a network of locations, all operating according to the same quality management systems. This enables them to seamlessly transfer translation work between teams as needed, without the risk of compromising quality standards. Desktop publishing considerations Many of the documents commonly used in the life sciences industry which require translation (IFUs/DFUs, case report forms, user manuals, clinical study protocols, drug registration documents and regulatory compliance documentation) also require formatting for publishing or printing. Depending on the languages involved and the requirements of the client, this process can bring its own challenges. Ability to work with documents authored in multiple software programs and versions Ability to process translations that encompass doublebyte characters (required for languages such as Arabic, Chinese or Japanese) Does your LSP have in-house desktop publishing resources? If they are outsourcing or subcontracting this function to another company, are the outsourced documents subject to a quality audit when they are received by the LSP? The best option is to choose a provider with extensive resources and experience. Not only does this provide the greatest control over quality standards, but it also gives you more flexibility in dealing with unanticipated last-minute document changes that may be made to publication numbers, publication dates or art files. For these reasons, LSPs that provide formatting for publishing or printing should have the following credentials: Formatting expertise in matching source to target, with the capabilities to also implement client-specific layout requirements and preferences PC and MAC expertise Qualification standards for translators An experienced project manager is critical to the process, but what about the people actually performing the translation? The value that a language solution provider PAGE 5

6 brings to you, beyond managing the process, is a team of highly skilled translators. So how does the LSP qualify its translators? You may never meet or interview these individuals, but you still need to be certain the LSP has vetted them properly. At minimum, the LSP s translators should have the following credentials: A four-year university degree Be a native speaker of the target language Minimum of three years experience successfully translating from the source language into their native tongue Three references Insist that the LSP utilizes professional translators who have been vetted by testing and checking references. Be certain that they have in-depth expertise in the language pairs and the subject matter you require. While many LSPs can handle a Spanish-to- English translation of a contract, far fewer can handle highly technical terminology included in, for example, an engineering document for submission to a foreign ministry of health. Vendor management Once linguists are pre-qualified, they should be trained on the LSP s standard operating procedures, translation tools, systems and processes. After an initial test period of training and evaluation, the strengths of the linguist should be confirmed. These strengths should be used to match the linguist with the LSP s clients and their specific subject matter. It is the duty of the LSP to identify their client s needs, requirements and expectations and match linguists to these criteria. Linguists should be expected to provide exceptional quality work at all times. At every stage of the translation process, feedback should be given by the LSP to their linguists to improve their skills. 3. SELECT AN LSP THAT CAN INTEGRATE WITH OR PROVIDE A CONTENT MANAGEMENT SYSTEM TO STREAMLINE THE TRANSLATION PROCESS One of the most dramatic ways to transform your translation processes is to manage your documentation in a languageenabled Content Management System (CMS). Many companies already manage their native content in a CMS in-house, but do not have the means to manage translations in their existing CMS environment. Imagine the efficiencies that could be achieved by embedding the language translation process directly into the content editing life cycle. In this scenario, as changes are made to content source files in the native language, they are also automatically updated in all translated documents containing the same source content. Companies who have adopted this model have achieved dramatic improvements in accuracy, efficiency, cost management and time-to-market. CMS integration options In some cases, it may make sense to ask your LSP to integrate their language translation system to share information with your existing CMS. Ask your LSP to outline their experience in this PAGE 6

7 arena. Have they integrated their language system with other industry-standard CMS solutions? Do they have technical staff and resources to assist you with the integration mapping and installation? The best providers have established a track record of managing such integrations and should be able to provide references. Take advantage of their experience in developing the best solution for your approach to language-enabled CMS. If your company is planning to purchase a CMS, ask the LSP what recommendations they may have. Well-established LSPs will likely have relevant experience with other systems that may be helpful to your assessment. They may also have established partnerships with industry standard CMS providers. This means that they have already created a standard systems interface between their language translation system and the host CMS, eliminating the time and cost associated with custom integration. Web-based language-enabled CMS solutions Another consideration is the option of a Web-based CMS. In this scenario, the CMS is hosted by the provider, via the Web eliminating the time-consuming and costly process of implementing hardware and configuring an on-site CMS. These solutions are now available as part of a language-enabled content management solution. Ask your LSP if they have established any partnerships with CMS companies offering this solution. 4. LOOK FOR AN LSP THAT CAN LEVERAGE AND INTEGRATE TECHNOLOGY Today s leading language translation providers have streamlined their services using technology that simplifies sharing and management of content, and facilitates better language translation. Make sure your language partner provides the right technology for your needs. Consider the following: Web-enabled project management tools. Does the vendor utilize a Web-based project management system that allows you to submit projects, obtain quotes automatically and track the status of your projects? An LSP should have multiple project management teams in their various offices to handle large projects with aggressive turnaround times. Additionally, these teams must be able to work simultaneously in real time via a Web-based system. Translation memories. Does the LSP work with a translation memory (TM), where translated text segments (blocks, paragraphs, sentences and phrases) can be stored and reused? If so, what is their approach for maintaining, distributing and updating the system? Who owns the files? It should be the intellectual property of you, the client, and the LSP should be willing to make it available to you upon request. Language glossary. Your LSP should be able to provide an easy-to-use glossary building tool that can be used to create, update, manage and distribute glossaries to the translators PAGE 7

8 and team members working on your projects. Glossaries help enforce consistency and quality within and across documents by enabling your team to easily locate and reuse previously approved terminology. This will prevent errors, create consistent translations and clarify critical terminology. Moreover, the glossary that you build should be your property, maintained as a courtesy for you by your LSP. 5. BE CERTAIN THE LSP CAN SUPPORT YOUR INTERNATIONAL BRANDING EFFORTS Your language services provider should also be considered a valuable resource on any branding efforts. For example, imagine that your company is about to launch a major branding initiative, involving 200 individual IFUs authored in three different desktop publishing formats. Of these documents, some have been translated into ten languages, but some require the addition of five new languages. In addition, imagine your source text changed along the way. What role can you expect your LSP to play? Depending upon the partnership, you may be able to leverage your LSP as an extension of your authoring team on an as-needed basis. Following are some questions to consider: Does the LSP have previous rebranding experience? What does it include? Will their past experience lend to process improvements for both parties? What human and technology resources can the LSP provide? Are those human and technology resources enough to support the volume of work that your rebranding project entails? Has the LSP handled a project of this size in the past? Can the LSP provide references for past rebranding projects? Can the LSP accommodate your deadlines? How? What type of quality will they deliver? How can they demonstrate this? Does the LSP have sufficient experience/knowledge to work independently or will they require frequent handson guidance from you? In the best scenario, your LSP should have the expertise, resources and technology to manage the entire process, from original acquisition of the source documents through translation, layout and final production all managed according to ISO quality standards and in adherence with your company s standard practices. At a minimum, expect the LSP to provide you with print-ready documents that meet your deadlines, quality, brand and revenue objectives. SUMMARY As the preceding pages attest, there are many reasons why choosing an LSP should not be solely a price-based decision. Select an LSP who understands the precision, adherence to deadlines and risk management requirements of the life sciences industry. Make sure that it offers the right combination of expertise, infrastructure and resources to deliver the greatest benefit to you. PAGE 8