Localization is a mandatory step for all global life-science companies — but doing it successfully is by no means a given.
In order to find out more about which priorities life-science companies should have when it comes to localization, we sat down with Bruno Herrmann, global advisor to many life-science companies around the world to learn about what does localization success look like in such a complex industry.
Bruno, what is the first thing that LS companies look to have in their localization journey?
The first and foremost objective is to establish effectiveness and efficiency. This is enabled by another very important objective which probably is number two here, which is the creation of an ecosystem that can empower and support all localization activities, and even all content-operation activities. So that is the foundation, if you will, to achieve efficiency and effectiveness.
There is a also driver that we call the ‘3C driver’ which stands for compatibility, connectivity, and centralization. All of these factors go beyond content-localization operations and make them all more cost- and time-effective for life-science companies, specifically due to the compliance that they have to consider at every stage of content operations.
You mentioned efficiency but that is a broad term. Can you specify more about what type of efficiency?
When we talk about efficiency and effectiveness in life science, the number one objective is time effectiveness. This is, of course, paramount for several reasons, not just because of compliance because of regulations. Dependency on time and delivering content on time stems from all these regulations, but also it has an impact on finance. Every delay or every piece of content that can’t be created, localized, or submitted in time is a loss of financial resources at best, and costly penalties at worst.
The second is content quality. Let’s use the word ‘quality’ instead of efficiency here. Content effectiveness is again driven by several criteria which are all usually well explained and well defined in SOPs (standard operating procedures), that stipulate that content must be accurate and precise.
Last but not least, is cost-effectiveness. Companies need to make the most of the budgets that are dedicated or allocated to localization because despite it being a mandatory activity for all life-science companies as part of compliance and regulations, it’s still a huge investment that needs to be maximized. However, time and content effectiveness are the main targets for localization teams.
Companies have to strike the right balance between automation and human contribution. It’s very important to automate as much as it is safe to do so.
Bruno Herrmann
Global Advisor
What are the main challenges that life-science companies face during localization and how do they overcome them?
SOPs certainly pose the biggest challenges, because they reflect everything that has to be done from a translational, localization perspective to meet regulatory requirements, so that is something that no life-science company can escape. Of course, these SOPs require not just full compliance or thorough implementation, but also require a lot of work in terms of operations.
What type of operations?
When I say operations here, I mean, of course, the people working on the content. You have different types of people working on the end-to-end process, not just translators and linguists but also medical writers, clinical trial teams…
So integrating them into a single workflow becomes critical.
Exactly. For this reason, processes and workflows have to be well-defined and properly followed, and this is something that is even more sensitive in some content operations, like linguistic validation or in meeting the latest EU-CTR regulations, which is a European Union clinical-trial regulation.
Therefore, workflows are important in building the localization ecosystem, to make sure that everything during translation, localization, and any other content operation remains as smooth as possible. The ecosystem itself is what enables connectivity among all repositories, tools, and systems, ensuring they are all compatible with each other.
Talk us through the decision-making process of choosing the right localization technology
To some extent, it’s not so different from any other procurement or selection process in other industries. However, it is of course very specific and more sensitive in this industry, since we are in a regulated environment just like it would be for finance or legal companies. First of all, there is a great deal of compliance-related procedures that play a big part in the selection process. And then the right tool as a hub for the ecosystem needs to be chosen, such as a translation management system, and it goes from there.
How does a TMS as the central hub for all localization activity help life-science companies in particular?
Among its many useful features, it provides automation. But of course, companies have to strike the right balance between automation and the need for “Human in the loop” as we say, or human contribution. It’s very important to automate as much as it is safe to do so. Also, when it comes to the tool-selection process, it is important to highlight if it will be able to connect to different repositories, and perhaps even integrate them into the ecosystem.
Most life-science companies have a lot of content, even at the source level. It’s a must that this tool can handle big volumes. Another sensitive point is how it is going to centralize activities and allow companies to measure the project’s effectiveness in terms of cost and time, as I mentioned previously.
Lastly, what advice would you give life-science companies embarking on their localization journey or searching for the right solution?
That’s a difficult question. From an operational perspective, it’s important to make sure that the solution that you’re going to use for your localization journey is not just fit for purpose today, but that it can be scalable in the future.
Why is scalability so crucial?
Scalability is an essential requirement because content is changing, volumes are growing, etc. so operations have to be scalable as well. From a purely technological perspective, my main advice would be to try to build your localization technology stack or localization platform with the perspective of an ecosystem in mind, so that even if you’re just selecting a few components today, like a TMS or a CAT tool, that at least you start by thinking about how they can connect among each other and with other systems to drive efficiency.
And how does this affect any potential additions to the ecosystem?
That’s going to make any additional tool more effective because it will fit in more seamlessly rather than just being another system somewhere in the organization working on its own. Having a connected and compatible ecosystem is paramount.
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