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Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges
 

Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges

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Presented by Inna Kassatkina at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis, IN....

Presented by Inna Kassatkina at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis, IN.

Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects’ human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process.

* Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management – from regulatory, financial, and efficiency perspectives.
* Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.

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    Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges Presentation Transcript

    • Centralized Translation Processes: Overcoming Global Regulatory and Multilingual Content Challenges Inna Kassatkina, President Email: inna@globallanguages.com Tel: (949) 798-1400 www.globallanguages.com 1
    • Global Language Solutions Founded in 1994, Global Language Solutions (GLS) is a full service ISO 9001:2000 certified translation company delivering solutions in over 100 languages. • Specializes in professional translations, website localization, cultural review, linguistic validation, multilingual typesetting/ graphic design, interpreters, and medical regulatory consulting services. • WBENC-certified women's business enterprise (WBE) based in Aliso Viejo, California. • In-country representatives in over 30 countries • Member of the American Translators Association, DIA, ACRP, RAPS, APHA www.GlobalLanguages.com 2
    • Session Overview Accurate translations of clinical trial documents play an important role in meeting global product demands. Mistakes from poorly done translations can result in product delays, cost overruns, malpractice or product liability lawsuits, and confused subjects / patients. This session will address: • U.S. demographics and impact on life sciences / healthcare industry • Regulatory, language, and cultural issues • Challenges of managing global content • Centralizing the translation process www.GlobalLanguages.com 3
    • Growing Need for Language Translation Projection: the global pharmaceutical market will double over the next 12 years (to $1.3 trillion)1 Facts: 47 million people, or 18% of the total U.S. population aged five and over, speak languages other than English at home. Since 1990, the number of non-English speakers at least doubled in six states: Nevada (193 %), Georgia (164%), North Carolina (151%), Utah (110%), Arkansas (104%), and Oregon (103%). 2 Commonly Known Fact: Hispanics are the largest minority group in the U.S. – 41.3 million people as of July 2004. 3 Question: Do you know the second largest non-English speaking minority group in the U.S.? How about in your own state? Sources: 1 PricewaterhouseCoopers, “Pharma 2020: The Vision” 2 U.S. Census 2000 3 U.S. Census Annual Report released on June 9, 2005 4
    • Top 10 Foreign Languages in California 5
    • Top 10 Foreign Languages in New Jersey 6
    • Language Translation Needs of the Healthcare & Life Sciences Industries: • Healthcare services system (insurance, hospitals, managed care facilities) • U.S.-based and global clinical trials • Medical and pharmaceutical product marketing 7
    • Language Barriers Result in Difficulty Getting Care in the U.S.: • 1 in 3 Latinos is uninsured compared to 1 in 5 African-Americans and 1 in 10 white Americans • 3 in 10 of the Latinos surveyed by the Kaiser Family Foundation say they have a problem communicating with healthcare providers • 50% of the surveyed Latinos who speak predominantly Spanish attribute those difficulties to language barriers Source: Health Poll Report by the Kaiser Family Foundation 8
    • Language Barriers Result in Difficulty Getting Care in the U.S.: • 20% of Spanish speaking Latinos do not seek medical treatment due to language barriers: 1) difficulty explaining symptoms/concerns to healthcare providers 2) reluctance to ask questions (“saving face”) 3) lack of medical treatment follow-up SUMMARY: When dealing with Non-English speakers, not only literacy but also language and cultural issues must be addressed. Source: Robert Wood Johnson Foundation 9
    • U.S. Regulations and Guidelines Pertaining to Language Translation • Civil Rights Act of 1964 (Title VI) and revised Guidelines of the U.S. Dept. of Health & Human Services (Office of Civil Rights) protect patients with Limited English Proficiency (LEP): http://www.lep.gov • OHRP set translation guidelines for clinical research: http://www.hhs.gov/ohrp/ • FDA regulations (ex., 21 CFR 56.111) govern language translation in clinical research and marketing of the medical devices and pharmaceutical products 10
    • • Medical Devices Directive (MDD) quot;Directive 93/42/EEC of the European Parliament and of the Council,quot; Official Journal of the European Communities (June 14, 1993) • In-Vitro Diagnostic Devices Directive (IVDD) quot;Directive 98/79/EC of the European Parliament and of the Council,quot; Official Journal of the European Communities (October 27, 1998) • European Directive on Clinical Trials: quot;Directive 2001/20/EC of the European Parliament and of the Council,quot; Official Journal of the European Communities (April 4, 2001) • Global Harmonization Initiatives: Medical Devices – GHTF (www.ghtf.orf) Pharmaceuticals – ICH (www.ich.org) 11
    • Life Sciences Product Life Cycle: Translation Support • Discovery/Research/Preclinical • Clinical • Manufacturing • Sales & Marketing 12
    • Life Sciences Companies’ Departments Requiring Language Translation • R&D / Clinical Operations • Regulatory • Manufacturing • Global Documentation • Marketing • Advertising • Legal • IT • Human Resources 13
    • Cost Per Word vs. Value • Translation services are not a commodity • Cost per word vs. value • Use of statistics in translation memory tools • “We have competitive prices, fast turnaround, and great quality” – all translation agencies sound the same. • So how do you select the right translation provider for your company? 14
    • Procurement of Translation Services: Three Main Objectives • Purchasing translation services = providing a solution in support of your company’s globalization efforts. • Vendor selection process should be done periodically, not every time a translation project comes up • Procurement of translation services should be done the same way as most other services - in a centralized fashion 15
    • Centralized Procurement: Vendor Selection Process • Appoint the primary person/team in charge of vendor evaluation • Create a questionnaire/internal RFI form(s) allowing you to collect the following information from each department or division involved in translation: – current translation needs and requirements – past translation experience, including the “pain points” in dealing with specific project- or vendor-related issues – past translation spending ($$), including pricing and total translation spending in a given fiscal period – projected translation spending ($$) for the next fiscal year 16
    • Centralized Procurement: Vendor Selection Process • Identify a list of existing vendors and potential new vendors. Things to look for: – expertise in your vertical market – client references (check them!) – defined and documented QA process – prompt communication at all stages • Send a formal RFI to all vendors, prior to discussing specifics of a potential contract or negotiating prices. Evaluate the responses, and narrow down your vendor list. • Prepare a total cost RFQ/RFP. Make sure you identify all of your translation requirements/components, which will allow: – vendors to quote a firm cost on each item, and – your company to compare “apples to apples”. 17
    • Centralized Procurement: Vendor Selection Process • Schedule telephone conference or face-to-face presentations with the vendors whose proposals seem to address all or most of your company’s needs. Invite your team members, especially those with prior experience in managing translations, to participate. • Award the translation contract to one or several translation providers, depending on your company’s size, structure, and language needs. • Make sure that all company departments are aware of the chosen translation vendors and use them for the duration of the contract. 18
    • Centralized Translation Management • One vs. several translation vendors: If several vendors have been selected for a specified period of time, each vendor’s scope of work has to be clearly defined. • Centralized management of terminology glossaries (vendor- independent) and translation memories (TMs). • Challenges of managing global content: – overwhelming amounts of information to manage – content consistency is difficult to manage even in one language (source content creation) – content management in multiple languages is further complicated by the need for content adaptation in foreign markets 19
    • Centralized Translation Management • Content management challenges are overcome by integrating content management systems (CMS) with translation management systems (TMS). • In most cases – except companies with internal translation departments and no need for outside translation vendors – the client’s CMS can be successfully integrated with the translation vendor’s TMS. 20
    • Organizing the Translation Process – Do It Right! 1) Determine your target audience, its cultural and education level, and the purpose of the translation 2) Address readability issue of the original documents: a) aim for 4-8th grade reading level b) use “plain English” (shorter sentences, less complex grammatical structures, etc.) c) avoid excessive “legalese” and “medicalese” in the text 21
    • Organizing the Translation Process – Do It Right! 1) Replace English idioms and catchy phrases with their equivalents in the target languages: a) “Dr. Nibbler” in English  “Dr. Bocado” in Spanish b) Example of how marketing lingo gets translated: Beware of the 3 B's: Recuerda las 3 “C”: Bad for Brain - can't think Malos para el Cerebro – no clearly puedes pensar con claridad Bad for Bones - takes calcium Malos para el Calcio – te lo away quitan del cuerpo Bad for Body - makes you Malos para el Cuerpo – te overweight engordan 22
    • Organizing the Translation Process – Do It Right! 1) Use culturally appropriate images, colors, proper names, etc. in translated collateral materials and localized websites 2) Use translation memory (TM) tools Translation memory (TM) software analyzes repetitive text in the source documents and then queries a translation memory database to identify previously translated segments. TM tools ensure consistency of terminology, expedite future document revisions, and reduce overall translation costs. These tools should not be confused with Machine Translation (MT) software, which is unusable for any publication-quality materials. 23
    • Organizing the Translation Process – Do It Right! 1) Turn to professional translators. They are: a) native speakers of the target language b) not simply bilinguals but professionally trained linguists c) not jacks of all trades but translation experts in a particular industry or field d) members of professional associations (American Translators Association and various industry associations) 24
    • Organizing the Translation Process – Do It Right! 1) Don’t let translators “play lawyer”. Example: Translation of informed consent forms (ICFs) for clinical research. When translating ICFs, translators cannot modify its key sections (i.e., Risks, Compensation, etc.). They have to stick to the wording of the original ICF. Since you may not be familiar with the language the ICF is being translated into, make sure you communicate this to your translation provider upfront. 25
    • Typical Translation Process: Stage 1 - Groundwork • Assignment of a project manager. The project manager will be the client's main contact during all stages of the translation project. • Selection of a project team. The team will include translators, editors, proofreaders, desktop publishers, and localization engineers. • Development of a project tracking chart. It should specify deadlines for completion of each stage of the project - translation, editing, proofreading, DTP, etc. • Development of specialized bilingual glossaries. Glossaries are essential for large-size or ongoing projects. They are created for each source/ target language pair and should be reviewed by the client prior to translation of the entire document(s). • Utilization of industry-specific translation memory (TM) tools. TM tools ensure consistency of terminology and reduced overall translation costs. 26
    • Typical Translation Process: Stage 2 - Translation • Translation stage. Translation by is performed by one or several native speakers, depending on the project size and deadline. • Editing stage. Native speakers of the target language (editors) ensure the technical and linguistic accuracy of the translated text. • Proofing stage. Documents are checked for proper hyphenation, punctuation, and formatting in the target language. • Review by client. After the translation is completed, the document is sent to the client, who, in turn, can send it for an in-country review. • In-country review (optional). Review of the final translation by in- county professionals with industry backgrounds. • Consider back translation. For certain healthcare and marketing materials (advertisements, ICFs, product labels) consider back translation as the ultimate test of the translation quality. 27
    • Typical Translation Process: Stage 3 – Review & Delivery • Incorporation of changes. For a specified period of time, the translation provider should offer to correct all errors and omissions free of charge, except for changes made by the client in the source document rather than the translation. • Desktop publishing stage. The documents are typeset and formatted in accordance with the client's specifications and in the same programs in which the original documents were created, whenever possible. • Final product delivery. Upon receipt of client’s approval, translation provider will deliver the final product to the client in the requested format. 28
    • Test Translations With the Audience for Which They Are Intended! • Offer the translation to a small group of people to read • See if these people can understand and remember the information presented to them • Identify any language dialect-related difficulties and correct them • Find out how information could be explained better and consider making the changes 29
    • Concluding Thoughts • Follow strict quality assurance procedures, be it with your on- staff translators or through a third-party translation agency. • All documents are first translated, then edited, and finally proofread by experienced professional translators with life sciences / clinical research background. • Translation memory tools reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds. • Life sciences professionals involved with multilingual content can benefit from a project management approach to content management – from regulatory, financial, and efficiency perspectives 30
    • Finally, some humor… • English sign on a doctor’s office: “Specialist in women and other diseases” • “PET Scan” translated as “examination of domestic animals” • “Keep out of reach of children” translated as “prevent children from stretching” Don’t let anyone ever laugh at your expense!  31
    • Any Questions? Global Language Solutions, Inc. 25 Enterprise, Suite 500 Aliso Viejo, CA 92656 Tel: +1-949-798-1400 Inna Kassatkina, President inna@globallanguages.com 32