McElroy's LIFE SCIENCES TRANSLATIONS
Clinical and regulatory client documentation has been a cornerstone of our translation and localization work for much of McElroy Translation’s 40+ year history. Our experience serving this community covers every aspect of global medical and pharmaceutical business needs, including translation of all types of clinical trial documentation in all languages:
• Informed Consent Documentation
• Case Report Forms
• Patient Information Sheets
• Lab Reports
• Serious Adverse Event
• Clinical Trial Reports
McElroy Translation’s clinical research and development clients are commonly complying with specific regulations for back translations. No matter what the specs, we can work with you. Additional services we have provided include:
• Into-foreign-language translations by two separate translators resulting in a harmonized, consensus translation and reconciliation report
• Additional reviewers
• Translation memory maintenance
Pharmaceutical translation is a sophisticated process with exacting levels of language quality control and requiring multilanguage output for successive stages of drug development. Volumes of content vary widely from single brief patents, correspondence, and twenty-patient Phase I clinical trials to twenty-language patent applications, regulatory submissions, inch-thick licensing agreements, extensive thirty-plus-language Phase III clinical trials, thousands of pages of process, MSDS, and manufacturing documentation, precise multilingual patient information, medical packaging and insert materials, and finally online and print marketing and informational materials authored and translated for both medical professionals and consumer audiences.
As the fields within medical biotechnology have expanded, so have the volumes of material requiring translation for research, patent applications, clinical trials, patient information, and marketing. This now presents biotech firms with the additional challenge of obtaining increasingly large volumes of translated content in emerging areas of biotech science. The resulting bottleneck increases translation costs and turnaround and can potentially impact quality.
MEDICAL DEVICE TRANSLATIONS
In medical device translation services, Class II and Class III medical devices, in particular, demand greater investment in the translation of associated documentation to mitigate risk. Because labeling is such an integral component of risk management in medical device use, obtaining a high-quality translation targeting the intended audience, e.g., patient, surgeon, or lab technician, is critical.
“McElroy Company has been a provider of translation services for the National Institutes of Health since Fiscal Year 1988 as one of a small group of vendors under our Blanket Purchasing Agreement system of procurement. During that time we’ve replaced a number of vendors because of dissatisfaction, but have kept McElroy because of the company’s consistent performance in the various aspects that make up good service: quality, timeliness, and professional attitude. McElroy is by far the most accommodating of our vendors, and certainly the most pleasant to deal with. The company provides us with a wide variety of source and target languages, both into English and from English into foreign.”
Life sciences translation and pharmaceutical translation services include:
• In-Country Review
• Back Translation and Reconciliation
• Website Translation
• Marketing Materials, Publications, and Labels
• Desktop Publishing (DTP) & Custom Formatting
• Multimedia—Coding, Dubbing, and Subtitling
McElroy Translation, as a division of TranslateMedia, is certified ISO 9001:2008 and EN 15038:2006. ISO ensures that quality assurance processes are clearly defined and each step of a project is tracked, monitored and scored. EN is setup specifically to solve issues of quality within the translation industry by setting benchmarks for linguist qualifications, translation workflow and provider/client communication procedures.
Contact our life sciences business development manager for more information.
McElroy Translation’s certifications are notarized documents signed by an authorized agent of McElroy Translation which indicate that the translation has been professionally and competently translated. Our certifications are accepted by the U.S. PTO, the FDA, and other U.S. and international regulatory agencies.
We strongly recommend in-country reviews on the client side, when schedules and resources allow it. Although referred to as “in-country,” these are often performed by a colleague who speaks the target language and is familiar with the terminology choices, often regarding proprietary products and processes, in use in that language within the company.
Reviewing such preferences allows us to incorporate them into our translation memory database, so that continuous upgrades in customizing output can be achieved. Please see additional information on this process in our data sheet “In-Country Review Tips.”
BACK TRANSLATION AND RECONCILIATION
Frequently used as a quality control method by IRBs, pharmaceutical, and medical device companies, a back translation requires that a translated document be translated back to English. McElroy has developed a three-stage process which includes a final review by a third translator to compare the original, foreign language and back to English documents. A report is submitted that provides details regarding where variations occurred, which document they were introduced in, and whether the variation affects the integrity of the document. If any errors are found, the documents are updated and finalized prior to delivery, with the reconciliation report providing an account of all changes.
McElroy Translation works with your product, marketing, and corporate teams to develop a multilingual website that is linguistically and visually appropriate for your target audiences. The final product will be culturally appropriate to the target market while reinforcing your carefully crafted branding. Updates can be managed centrally while still allowing local input.
MARKETING MATERIALS, PUBLICATIONS, AND LABELS
McElroy Translation offers expertise and guidance in the production of all types of marketing, labeling, and manufacturing. Experienced account managers, project managers, and a full-service production department ensure that your collateral is appropriately targeted, expertly translated, and reproduced in any DTP application in any language. These offerings, which include localization of websites and software, ensure that McElroy can provide turnkey solutions for all of your marketing and publication needs.
DESKTOP PUBLISHING (DTP) AND CUSTOM FORMATTING
McElroy Translation retains desktop publishing experts who are experienced with all of the major publishing software platforms. Our DTP specialists are trained to spot potential layout and design issues that arise from complex scripts and fonts (e.g., double-byte and bidirectional issues) and are able to deliver projects quickly, accurately, and cost-effectively.
MULTIMEDIA—CODING, DUBBING & SUBTITLING
McElroy’s multimedia resources include professionals who specialize in providing talented localization of media output formats such as websites, web applications, audio, video, CD-ROMs, eLearning tools and applications, and movie platforms. We are capable of handling every step of the process, including culturally appropriate translation, production, and editing.
TRANSCRIPTION + TRANSLATION
McElroy Translation provides high-quality transcriptions of audio and video files. Source material can be transcribed from a CD, DVD, tape, video cassette, MP3, AVI, mpeg, or wav file. If you are unsure about the file format of your source material, please contact us. There are multiple formats for audio and video files with multiple conversion or playable solutions.