Life Sciences Translation: How to Localize your Product

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If you're planning to launch Life Sciences products into a new market, whether it is medical devices, vaccines, or disease management products, you have to be sure that the translations related to these products are accurate. Failing this, confusing translations may lead to negative, even life-threatening results, and the company may face serious legal and financial repercussions.

In this article, you'll learn:

• why you should pay attention to the localization of your Life Sciences product
  
• what the common Life Sciences documents are
  
• global Life Sciences market trends
  
• what challenges you may face and how to deal with them
  

how to make the most of localizing your product

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Life Sciences comprise all fields of science that involve the scientific study of living organisms: plants, animals, and human beings.

The Life Sciences industry includes but is not limited to:

• Anatomy. The study of form and function, in plants, animals, and other organisms, or specifically in humans.
  
• Bioengineering. The application of technologies to living things, such as humans and plants.
  
• Cell biology. The study of the structure, function, and behavior of cells.
  
• Genetics. The study of genes, genetic variation, and heredity in organisms.
  
• Medical devices. Any instrument, apparatus, appliance, software, implant, reagent, material, or anything else that helps healthcare providers diagnose and help patients recover from disease and improve their quality of life.
  
• Pharmacology. The study of how drugs exert their effects on living systems.
  
• Veterinary medicine. The branch of medicine that deals with the prevention, diagnosis, and treatment of disease, disorder, and injury in non-human animals.
  

These are just a few aspects, as there are many more branches that are dedicated to improving and saving the lives of organisms.

So, as far as medical content is concerned, it needs to be of the highest quality. There is no room for mistakes because translations can affect people's health and even be a matter of a life or death. Moreover, poorly translated content can end up in a lawsuit, involving significant expense.

Life Sciences is a highly regulated industry. Legal and regulatory requirements are constantly evolving in the Life Science sector to keep up with innovative therapies, diagnostics, and other medical technologies, as well as increased service provision by manufacturers and other suppliers. That's why it's essential to ensure the quality of Life Science localization services. Translation services providers must be familiar with the relevant industry and local regulations and follow international quality standards, such as ISO 9001 and ISO 17100.

Let's look at the types of Life Sciences Documents that usually require translation services.

• Research & Development
  
  • Patents
    
  • Scientific Research Articles
    
  • Lab Reports
    
  • Validation Reports
    
  • Declarations of Conformity
    
  • Adverse Event Report Forms
    
  • Informed Consent Forms (ICFs)
    
  • Patient Diaries
    
• Clinical Research
  
  • Study Protocols
    
  • IRB/Ethics Committee Submissions
    
  • Clinical Trial Documentation
    
  • Pharmacological Studies
    
  • Investigator Brochures
    
  • Patient Education (CMI and PHI)
    
  • Deviation Reports
    
  • Data Sheets
    
  • QMS Audit Documentation
    
• Regulatory Affairs
  
  • Registration Dossiers
    
  • CMC Documentation
    
  • Labels and Package Inserts
    
  • Instructions For Use (IFUs)
    
  • Case Report Forms (CRFs)
    
  • Site Operations Manuals
    
  • IVRS Prompts
    
  • Adverse Event Reports (SAEs)
    
  • Patient-Reported Outcomes (PROs)
    
• Sales & Marketing
  
  • Websites
    
  • Software and Hardware
    
  • Marketing Materials
    
  • GMP Documentation
    
  • Batch Records and MBRs
    
  • Pharmacovigilance and Postmarketing Surveillance
    
  • Patient Recruitment Materials
    
  • Patient Questionnaire
    

According to Persistence Market Research, the global Life Sciences market was estimated at more than US$ 2,500 million in 2015 and is expected to reach approximately US$ 4,200 million by 2025. The market is expected to grow at a CAGR of 4.3% over the forecast period.

The trends that are shaping the Life Sciences industry include:

• More advanced vaccines. The industry's focus is to create personalized therapeutic cancer vaccinations based on mRNA technology. Also, researchers will develop more effective vaccines to protect against multiple coronavirus strains simultaneously.
  
• Reduction of racial inequality in diagnostics. Medical professionals will be able to use the "Mind the Gap" manual to see how disease symptoms appear on dark skin.
  
• Digital twins. This technology allows healthcare professionals initially to use a digital version of a patient that contains medical records, genetic data, and other biomarker information. Digital twins can help avoid side effects and save costs, as doctors can use them to develop and test individual medicines.
  
• E-Immunotherapy. Can be used in place of invasive methods, for example in the treatment of autoimmune diseases. E-Immunotherapy implies electric stimulation of the brain, helping make neurological connections to boost immune function.
  
• Individual implants from a 3D printer. 3D printing makes custom implants more accessible and provides new opportunities for working with biocompatible materials.
  

Technavio experts expect that the global life sciences software market will grow by USD 2.55 billion during 2020-2024, with a CAGR of over 7% throughout the forecast period. The report offers an up-to-date analysis regarding the current market scenario, the latest trends and drivers, and the overall market environment.

The key market trends, according to the report, are as follows:

• The pharmaceutical industry is the main driver of market growth. Pharmaceutical companies can benefit from the global healthcare standard offered by life science software. It enhances the existing ERP, augments the capabilities of logistics partners, and collaborates with trading partners such as contract packagers. It also increases the visibility of the Life Science company and improves analytics and risk management aspects.
  
• North America was the largest life science software market in 2019. During the forecast period, this region will provide market suppliers with several growth opportunities. The need for security, easy access to data, and effective patient information management will be the main drivers of market growth in this region.
  
• The global life sciences software market is fragmented.
  

As COVID-19 spreads to businesses, the global life sciences software market is expected to see positive and significant growth in 2020-2024.

As we've already pointed out, poor quality translation can have severe consequences, especially in medicine. It can damage a company's image, put off customers and partners from your products and services, and even lead to life-threatening results.

At Palex we know that every word and detail is vital. That's why we perceive quality in two dimensions: quality of the process and quality of the output. In addition to project management and translation departments, we have our quality control and prepress services, and engineering and software development department. Thanks to this, we don't just translate various topics into more than 50+ languages; we offer our clients an integrated approach to their business tasks.

Our company is ISO 9001 and ISO 17100 certified and is a member of the GALA and ALC industry associations. To maintain a complex system, assuring quality in the translation company is a challenging task, which is audited annually by the supervision officers of a certifying body.

Quality isn't cheap. If you want to hire a professional translator, it'll take both time and money.

Some companies try to save by choosing the cheapest, fastest option they can find. However, they risk getting a low-quality translation, which costs even more to fix or redo.

Being aware of how acute the budget issue is, we've developed a system allowing for a budget economy. It involves termbases, translation memory, maintaining records for future use, and automation of repetitive tasks. As a result, you can save without compromising on quality.

For almost two decades, more than 50 clients have benefited from our Life Science localization solutions. Based on our experience, we've compiled a list of tips that will help you run your localization project smoothly and ensure high-quality translations.

• Find an experienced and reliable translation agency that can meet your goals and needs. Make sure the project manager and team members have experience in the specific field and are familiar with life sciences industry conventions and processes.
  
• Select a person in your company who will be responsible for communication and control of the work of professional translators. They must have experience in project management and translation.
  
• Consider a standardized process for your translations. Pay attention to how you plan to check the quality when you approve translated texts. Assign one or more people to answer any questions you might have about terminology.
  
• Make sure the source documentation is accurate and clear. If the source material is unclear or contains errors, there is a risk that mistakes and incorrect translations will be made in all target languages, which might ultimately lead to damage to human life in some situations.
  
• Ask your translation agency to create a multilingual termbase based on your company's materials, to ensure professional term management for all languages.
  

Let's look at the key stages of the translation process at Palex.

"Before anything else, preparation is the key to success." At the beginning of the project, we focus on identifying the goal. To do this, we create a requirement specification document that provides a comprehensive and unambiguous description of the task and the desired results, the essential conditions to which the service must conform, and the characteristics or features of each deliverable.

The purpose of writing a translation requirements specification is to make sure that both the client and the agency are on the same page regarding the project outcomes. Thus, the customer fully understands what they'll receive. The vendor can select the most appropriate resources and prepare a realistic schedule.

Based on the requirements and other factors, including the complexity of the subject matter, word count, and formatting, the budget and deadlines are defined and agreed upon with the client.

At this stage, we conduct content analysis to select the best matching linguists.

Next, we extract terms and prepare a glossary. Medical terminology can be complicated, so we make sure that every word is clearly defined. We also prepare a reference pack.

Translation of texts in Life Sciences, as previously mentioned, requires extra accuracy and care. Our translators are not only familiar with translation, but also have professional knowledge. In addition, they are professional linguists, fluent in both the source and target languages. At Palex we strive to provide our customers with the highest quality. That's why we apply the four-eyes principle, which helps ensure strict requirements for translation quality in compliance with the ISO 17100 standard.

In addition, the translated documents can be adopted for a specific market or group. This process is called localization.

After the translation is completed, we move on to editing. The goal of this stage is to compare the translation and the original text to check the translation for accuracy and style.

Quality assurance is an important stage in production for many industries, and the translation industry is no different. We perform linguistic quality assurance to detect errors, ranging from simple spelling errors to those which are harder to spot, such as missing terminology.

We also perform a formal QA with our versatile Verifika tool for glossary adherence, checking punctuation, complying with country standards, punctuation, etc.

At this stage, we send the translation to the client's reviewer (in-house linguist, subject-matter expert, end-user) for bilingual and/or monolingual revision. They check whether the document matches the requirements. After that, we thoroughly analyze the feedback from the client and incorporate changes suggested by the client's reviewer.

It's important to conduct localization testing among native speakers. When all the edits are made, and the customer is satisfied with the outcome, the text can be used for business purposes.

If you need Life Sciences translation and localization services, we'd be delighted to assist you. We are experienced in working with clients from all over the world and we are proficient in creating translations that correspond to international standards. Moreover, we're a leading provider of translation services in Life Sciences, with almost 20 years of experience. Feel free to contact us at sales@palexgroup.com.

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