Many types of life sciences documentation require translation as outlined by each country’s governing medical agency.
Some examples of content that may need to be translated include clinical trial instructions, medical device IFUs (instructions for use), software that runs surgical equipment, medical textbooks and more.
If you’re responsible for procuring professional medical translation services in this unique and highly regulated industry, here are seven things you should know:
1) Absolute accuracy
Medical translations are a specialization, and they require high-quality work. There is zero tolerance for errors in medical translation and editing—even an accidental numerical error on a pharmaceutical document could cause harm or death.
2) Subject matter expertise
Given the nature of the content, medical translations can’t be done by just anyone. Medical translations require translators, editors and proofreaders to be highly experienced subject matter experts in the specific medical field.
3) National translation requirements
The international medical industry is highly regulated, so be sure you work with a language services provider (LSP) that specializes in medical translations. In most countries, clinical trial documentation and medical labels (on containers, packaging and/or inserts) must be translated, however the requirements for translations in each country vary and are regulated by local agencies. For example, countries in the European Union follow the Medical Devices Directive 93/42/EEC, which defines translation requirements based on the type of content and user type, and also outlines requirements for countries that have more than one official language. An LSP that specializes in medical translations will know what’s required in each country and can help you successfully navigate the requirements.
4) Proper documentation
Within the medical field, the pharmaceutical industry may be the most specialized. This industry requires detailed documentation of all processes and products, with regulatory requirements requiring translated content to advance between stages. Translators should come from the pharmaceutical industry with experience translating a range of pharmaceutical content & documentation.
5) Cost considerations
High quality medical translations need to be performed and proofread by subject matter experts in the relevant medical field. Some translations must undergo the additional step of linguistic validation, depending on their use. Don’t compromise on quality by selecting the cheapest translator – when it comes to medical translation, quality has to be perfect.
6) Confidential information
Depending on the confidential nature of your content, you may need to ask your LSP to secure confidentiality agreements from the team members working on your project. An LSP should be able to accommodate this request.
7) Terminology management
Using correct, consistent terminology is a critical part of producing high-quality translations. If you don’t have one already, your LSP can help you develop a glossary of terms that will be used throughout your translation project/s. Establishing these terms before translations begin increases translation consistency while also saving time and money.
The biotech and pharmaceutical industries both work at the cutting edge of science to deliver medical innovations to patients around the world. While the intellectual property portfolios of each industry vary widely, the path to obtaining strong IP protection is similar. To recoup R&D investment, both industries need to file their parents broadly and on a global scale, and that path includes extensive patent translations.
What’s the difference?
Biotech & pharma are often used interchangeably but it’s important to understand the distinction. So before we cover the similarities between translation requirements for IP in the biotech and pharma industries, let’s take a brief step back to understand what types of products each industry covers:
- The pharma industry regularly seeks patents for new chemicals, pharmaceuticals, drugs, reformulations of existing medicines, as well as innovative manufacturing methods.
- The biotech industry is more wide-ranging with patents covering biological materials such as proteins, DNA, RNA, cell lines, hormones, engineered tissues, and artificial body parts. Biotech process patents can also include methods for working with DNA, proteins or cloning.
The question of patentability
It’s important to note that the nature of biotech innovations, especially those involving animals, plants and DNA, often makes them more challenging to protect because of the ongoing question of their patentability. In addition to the three global patent standards that an invention must be novel, non-obvious and useful, inventions must also cover a subject matter that is eligible for patent protection.
Many countries around the world are debating whether or not biotech innovations can be claimed by individual human beings or companies, which makes the international landscape for biotech patents extraordinarily complex as each nation works out its own set of rules and regulations.
Similarities in product development
Regardless of where you’re planning to file a pharma or biotech patent application, you will be required to provide extensive supporting documents about each phase of product development in that country’s local language. This continues after the patent has been issued and commercialization begins. A translation flaw anywhere along the way can slow down or even derail the entire process. For example:
- Preclinical studies — This phase often requires translations of internationally sourced case reports and data sheets before clinical trials can begin.
- International clinical trials — This phase requires expertly localized informed consent documents, personal information forms, case report forms, physician protocols and notes, and patient-reported outcome forms. Additionally, live interpretation services may be needed during this phase to help international teams communicate.
- Regulatory approval — Accurate and comprehensive translations must be submitted to national or regional patent offices, as well as other regulatory agencies, in regions where distribution of the product is anticipated. This includes dossiers, labeling, adverse event notifications, and other types of supporting documentation.
- Manufacturing — Documentation for Standard Operating Procedures (SOP), as well as health and safety materials, must be localized for each country or region in which the product will be manufactured.
- Marketing and sales — Customer-facing materials must be translated for each different market, expertly leveraging a deep knowledge of the local language and culture. This phase includes translating product websites, brochures, displays, advertisements, and other promotional materials.
Why a centralized translation source matters
It can take over a decade for a pharma or biotech innovation to go through all the phases of product development before it actually hits the shelves in your local pharmacy. Having a single language service provider (LSP) responsible for coordinating and delivering all of the various translations required throughout the product lifecycle guarantees a level of consistency and accuracy that simply can’t be replicated by the work of multiple independent agencies strung together along the way.
In addition to improving translation quality, using a singular LSP can save you time. Think about it this way: Instead of introducing and explaining yourself, your company and your invention to numerous agents repeatedly over what could be a 10+ year process, an LSP can set you up with a dedicated project manager who acts as your single point of communication for years to come. If you have questions, need clarifications, or require late-stage changes, the dedicated project manager is trained and positioned to shepherd your project to a successful conclusion.
Start early and start right
Now that it’s clear why an LSP is beneficial for biotech and pharma companies, let’s discuss how to choose one. First, the best time to start looking for an LSP is before entering the preclinical studies phase. This allows you and the LSP time to create and implement a clear project lifecycle calendar. Of course, an LSP can start working at any phase of product development, but it will be less stressful for you knowing it’s all taken care of from the start.
When selecting an LSP, you can check the credibility of an organization by asking about its ISO certifications. These are internationally recognized standards of excellence written by the independent, non-governmental International Organization for Standardization (ISO). There are literally thousands of ISO certifications to choose from, which (understandably) can seem a bit overwhelming. Here are three of the most useful ISO standards to look for in the language services industry:
- ISO 9001 — This certification means that a company meets international standards for maintaining a quality management system.
- ISO 13485 — This certification is based on ISO 9001 but adapted specifically for the medical device industry, with an emphasis on risk management and strict quality control.
- ISO 27001 — This certification means that a company meets international standards for information security management. Its primary goal is to help prevent data theft, loss and corruption.
Once you’ve found an LSP you trust, be sure to notify every relevant department in your company as to your choice. This will ensure that you consistently benefit from the quality control and cost-saving tools available to you. For example, biotech and pharma documents contain a great deal of repetitive text. Certain professional translation tools exist to cut out redundant work and increase consistency across projects. These tools are especially handy for families of related products:
- Translation memory (TM) — This tool creates a database of previously translated text segments from which human translators can retrieve and re-use words, sentences, and paragraphs.
- Terminology management and glossaries — Every company has its own terminology, branding, and way of expressing itself. To ensure the consistent use of language across all projects and documents, an LSP can construct confidential, client-specific glossaries of your organization’s terminology which translators can utilize while working on your projects.
Additionally, check to see if the LSP offers an online client portal where you can manage all of your company’s projects, submit new ones and leverage historical data like glossaries, style guides and TMs.
Why make things harder?
The documents required for biotech and pharma patents, regulatory approvals, and marketing are complicated and must be impeccably executed. Quality is king in these industries and either one cannot abide costly, potentially even dangerous, errors in translations. Years of research, millions of dollars and lives are literally at stake – which is why the alternative to using a centralized translation service can quickly border on the nightmarish: identifying, hiring, managing and also verifying qualified service providers in each and every single region or country in which a product is to be sold or where its ownership must be protected. The redundancies are stupefying. Instead, with a centralized translation service, a single good hire of the service itself ensures consistency, quality and timely delivery for years to come.
Morningside is excited to announce that IQ, the ground-breaking instant quoting feature on our IP Platform is now available for client use.
Designed specifically with our IP clients’ needs in mind, our secure, market-leading IP Platform streamlines and centralizes the patent translation & foreign patent filing process by letting you easily request quotes, place orders and manage IP projects all from one place.
Our newest feature, IQ, enables you to view instant and accurate quotes for patent translation, national filing and EP Validation — at the click of a button, from anywhere in the world. IQ gives you more control and visibility on costs, with fast quotes that help accelerate decision-making and avoid last-minute filings. IQ and Morningside’s competitive fee structure make IP budget management simple.
It’s just 3 steps to place an order:
1. Choose your countries
2. Receive your instant quote
“I love Morningside’s new cost estimator tool,” says Jan Weissenberger, Patent Assistant at Bozicevic, Field & Francis LLP in San Francisco. “All you need to do is just insert the PCT number or EP number (for validation costs) and the estimator finds your application. It walks you through each step. I liked this online tool a lot. It is much nicer than the ones we used in the past.”
Are you interested in learning learn more about IQ? The new feature is available to all our IP clients free of charge. You can request a demo from [email protected].
About Morningside IP:
Morningside is the largest IP-focused translation company in the world and a leader in foreign filing services. With a single instruction, Morningside can prepare high-quality patent translations and file applications in over 150 jurisdictions. Find out why over 1/3 of the Top 100 PCT filers in North America rely on Morningside for their patent translation & foreign filing needs.
NEW YORK, NY – Morningside Translations, a Top 25 global provider of language services, recently acquired life sciences specialist Net-Translators. Headquartered near Tel Aviv, Israel, Net-Translators provides high-quality translation, localization and multilingual testing services to leading global medical device manufacturers, pharmaceutical companies, life science research organizations, and software developers.
The addition of Net-Translators dramatically expands Morningside’s global life sciences practice and significantly extends its life science reach across Europe, the Middle East, and Asia-Pacific. Morningside is already one of the largest global providers of IP services to the life sciences sector and a major partner to life sciences companies for their regulatory and clinical translation needs.
“We are thrilled to bring Net-Translators into the Morningside fold. This acquisition perfectly fits our DNA as a language service provider focused on regulated industries where quality is paramount,” said Morningside Translations’ co-CEO, Roland Lessard.
As the Tel Aviv branch of Morningside, the Net-Translators team will continue to provide the same exceptional quality and service to clients, while also leveraging Morningside’s broad international presence and top-tier network of linguists and subject matter experts.
The addition of Net-Translators also makes Morningside one of the largest language service employers in Israel, where it has had a robust presence since 2006.
“This is a natural extension for us across EMEA and Asia where our patent and legal work is flourishing,” said co-CEO Tom Klein. “Clients in the U.S. and overseas are always asking us where else we can help them across their broader business portfolios. We’re proud to now offer expanded, specialized capabilities.”
About Morningside Translations:
Morningside is the fastest growing major language service provider in North America and one of the largest IP service companies in the world. Specializing in patent, life sciences, and legal services where accuracy and subject matter expertise are paramount, Morningside provides ISO-certified translations into more than 150 languages and offers a suite of technology-enabled localization and IP management solutions. Morningside is the trusted partner to thousands of organizations including Fortune 500 companies, Am Law 200 firms, and international regulatory bodies. Headquartered in New York City, Morningside has offices across the globe in San Francisco, London, Hamburg, and Tel Aviv.
Innovation is on the rise, with a handful of industries — namely IT, telecom and life sciences — driving patent growth worldwide. According to WIPO, “Patents granted by the EPO grew by 40% in 2016 – the fastest growth since 1983.” In 2016, the Chinese patent grant rate increased by 13% and in Japan and Korea it rose by 7%. As the number of granted patents grows around the world, the number of IP litigation cases has also grown – which is a serious concern for businesses and patent owners, given their high costs. Check out our infographic below to learn more about the latest trends in IP litigation and to get tips for overcoming IP litigation challenges.