What’s Cooking in Life Sciences Localization

Mark Shriner is the Strategic Sales Director for memoQ, leading the company’s market growth in the regulated industries. He has previously worked in several leadership roles in the localization industry including CEO Asia Pacific for CLS Communication.

 

Hello, and welcome to The Lab, a new column of updates and insights into the latest in life sciences localization. In this column, we will discuss the latest trends and innovations in technology, tools, and processes that are relevant to those working for, or providing services to, life sciences organizations. We will also look at the regulatory landscape for life sciences and introduce new business opportunities as they arise.

Why are we doing this? For starters, life sciences is an incredibly important, diverse, and robust business sector that includes medical devices, pharma, clinical trials, and contract research organizations (CROs). There has also been an explosion in vaccine development, trials, and delivery.

These sectors are all experiencing impressive growth and are expected to continue their current rate of expansion, or even surpass it, in the coming five to 10 years. For example, industry research provider Insight Partners predicts that the CRO market will grow at compound annual growth rate (CAGR) of 8.5% between 2021 and 2028. This will increase revenues from an already impressive $50 billion USD to $88.8 billion USD in the next seven years.

The medical devices market is predicted to grow at CAGR of over 5% from 2020-2027 resulting in a global market size of over $671 billion USD. Precedence Research, a market research provider, attributes this growth to advances in technology and the proliferation of wearable devices such as fitness trackers and activity monitors. In fact, some studies show that as much as 21% of the adult population in the US owns or has owned a fitness tracker.

Growth in the medical device market is also driven by factors including the medical needs of graying populations in the world’s leading economies and most populous nations including China, the US, Japan, South Korea, and many European nations, and the continued rise in chronic diseases including cancer and diabetes in those same countries.

While the prospect for steady continual growth is nice, it’s not all sunshine and rainbows. Organizations are under increasing pressure to get more products to more markets more quickly, keeping pace with the projected market expansion. At the same time, regulatory guidelines including GDPR, HIIPA, MDR, IVDR, and guidelines from the FDA in US and Japan’s PDMA must be adhered to and incorporated into best practices for data protection, privacy, and readability for all localization workflows.

For those involved with localization in life sciences, these pressures require optimized processes via the adoption of new technologies, tools, and improved workflows. Processes related to source content creation, structured content, and content templates are all being discussed as they can reduce costs and delivery times for both content creation and translation. Process optimization also helps to improve quality, consistency, accuracy, and readability, thus checking many of the required regulatory boxes.

The Rise of Structured Content

One example of using new processes and tools to meet business and regulatory needs is the increasing importance of structured content creation and use. By creating structured and reusable source content for all text that might be reused or translated, companies are achieving impressive savings in both time and costs. At the same time, they’re improving the quality of the final product.

By beginning the content creation process with the end in mind, organizations are finding ways to automate the creation and revision of product documentation, eliminate errors, improve readability, shorten the review and revision cycle, better adapt documents for digital submissions, and facilitate faster, more consistent translations.

The white paper, The Pharma Content Evolution: Content Reuse and Automation created by Val Swisher and Regina Lynn Preciado from Content Rules, explains how life sciences companies have historically produced large volumes of content but have done a less-than-optimal job of reusing that content. The problem starts with how the text is created, where it’s created, how it’s stored, and how it’s retrieved and repurposed.

The white paper points out that, “An analysis of any pharma company’s dossier content typically shows a high level of semantic similarity and linguistic variation. In other words, the content uses different words to say the same thing.”

Using different words to say the same thing causes a lack of consistency, can hinder readability, and makes leveraging source content for additional uses more difficult. One of the root causes of this problem is the fact that content has typically been created in various organizational silos.

For example, the teams responsible for quality, marketing, regulatory compliance, and labeling often have the need for, and create, almost identical product descriptions, instructions for use (IFU), and other important text. But instead of having a centralized content creation process producing material that can easily be re-used, each team re-invents the wheel every time they need something new.

Another hurdle to the efficient re-use of text is that content has traditionally been created and stored at the document level for one-off projects. This makes it difficult to search, retrieve, and use smaller parts of the document. This is especially true when the documents are stored in different parts of organization and not centrally.

So, for example, if you were looking for product description to be used in a regulatory filing, it’s inefficient to search through all the documents across all departments to hopefully locate the product description. It would be much easier if all product descriptions for a specific product were tagged as such and could be searched from a central repository. This would allow you to quickly compare all previously written descriptions, select the best option, and insert it into the new target document.

I say “insert” and not “copy and paste” because using a tool that allows for the automation of this process will both save time and reduce formatting errors. According to the previously mentioned white paper from Content Rules, by adopting an optimized processes for structured content creation, “You can speed content creation time by up to 400%. You can save at least 10% on your translation costs.”

And when this automated approached can be integrated with a translation management system, the benefits of lower costs, improved quality, and reduced turn-around times can be passed on to all target language translation work.

Lay Summary Best Practices

One area that lends itself to use of structured content is the creation of Lay Summaries for clinical trials. Regulation (EU) No. 536/2014, Article 37 (“EU-CTR”), requires trial sponsors to submit a summary — AKA a “lay summary” (LS) — that is understandable to laypersons for each clinical trial with pharmaceuticals into the EU Database. The LS must be submitted to the via the EU’s Clinical Trials Information System (CTIS) no later than 12 months from the end of the clinical trial and within six months for pediatric studies.

According to the Good Lay Summary Practice developed by the Roadmap Initiative and adopted by the Clinical Trials Expert Group, a well-designed lay summary will provide key information about a clinical trial in an easy-to-understand manner using “plain language” or “lay language.” It should use short words, sentences, and paragraphs, an active voice, consistent terms and words, and respect language and cultural sensitivity. On the other hand, an LS should not use technical, scientific, or promotional language and Latin phrases.

GOOD LAY SUMMARY PRACTICE THE PHARMA CONTENT EVOLUTION: CONTENT REUSE AND AUTOMATION

 

LS content should be created and presented in a manner that is understandable for the public at the age of 12 years. There are different guidelines for pediatric patients that include the importance of storytelling to convey a message.

The Good Lay Summary Practice guideline states, “Availability of a LS in a patient’s language in an important element of fair access to information. While the EU CTR nodes request translation, the EU CT Expert Group Recommendations suggest as a minimum, the LS should be provided in the local official language(s) of each of the countries where the trial took place, matching the languages employed in the Patient Information Sheet/Informed Consent Form (PIS/ICF).”

The document also makes recommendations on how to optimize the translation of lay summaries including the use of technology and states that, “…a well-managed translation process, and the use of glossaries, and pre-defined terminology are helpful for achieving successful translations of LS.”

It is also recommended that companies create LS templates as an “…aid for the efficient and consistent preparation of an LS.” Once templates are finalized they can be translated into all target languages and checked for readability. This would only require updated drug, effect, and report-specific content to be translated and added afterwards.

Post Market Surveillance – An Opportunity

Sometimes regulatory requirements can lead to new business opportunities for service providers. For example, the EU Medical Device Regulation 2017/746 requires companies to track the performance and feedback of any medical devices that have recently been taken to market. This “post-market surveillance” (PMS) includes the collection and review of any information related to the product’s use and performance, and is expected to generate significant volumes of content for translation.

According to a recent post from Barbara Peralta, Director of Life Sciences Solutions at Acolad Life Sciences, “These activities, as outlined in a post-market surveillance plan, must be maintained as long as a product is on the market. The goal of the PMS plan and system is to ensure patient safety; it must be included for all medical devices, requiring the production of PMS reports (PMSRs) or Periodic Safety Update Reports (PSURs), depending on the device’s class.”

Data can be pulled from a variety of sources including focus groups and customer feedback surveys, complaints and adverse event reports, media and literature reviews, Post CE Mark trials and Post Market Clinical Follow-up (PMCF). All of this content can come in various languages and must be translated in order to be used in the evaluation of a product’s post-market release.

Some documents such as the Summary of Safety and Clinical Performance (SSCP), which contains information on the safety and performance of a medical device and is required for class III and implantable devices, must be translated into all EU languages and updated annually. So clearly, there are large volumes of content to be collected, translated, analyzed, and disseminated.

One best practice for handling these projects is the use of machine translation (MT) to get a quick understanding of the nature of the content and flag any issues that raise concern. Flagged content should then be translated again using professional linguists and may require back translation to ensure accuracy.
Greater efficiencies are possible through workflow automation with a translation management system that can be accessed via a customer portal and leverages translation memories, term bases, and a choice of MT engines.

According to Acolad Life Sciences’s Barbara Peralta, the use of their portal “…allowed us to deploy our translation memory and machine translation technology in chained automated workflows with integrated linguistic pools. Thus, prepared and pre-translated content can flow easily through our linguistic review steps.”

When considering the projected market growth and when looking at some specific requirements in life sciences such as lay summaries and PMS, there are great opportunities for content and translation service providers. There’s also a place for MT, TMS, term base, content management system, and authoring tool vendors to help life sciences localization teams to scale, maintain standards for accuracy and quality, shorten delivery times, and meet regulatory requirements for readability and privacy.

Next time in The Lab we will be investigating some new technologies and tools being adopted by services providers and governments to streamline content and translation workflows and securely share important drug and device-related information with stakeholders.