Clinical Translation and Linguistic Validation at Scale with ICON’s Brian Mallon

SlatorPod #172 - ICON SVP Brian Mallon on Linguistic Validation

ICON plc’s Senior Vice President of Commercialisations & Outcomes, Brian Mallon, joins SlatorPod to shed light on the crucial role of language services within clinical research organizations (CROs). 

Brian recounts ICON’s growth journey, from a team of five in Dublin back in 1990 to its present-day workforce of over 41,000 across 50 countries. Brian outlines the clinical cycle for drugs or medical treatments, which consists of several phases aimed at evaluating safety, efficacy, dosage, and potential side effects before making them available to the public.

Brian reveals how language services play a vital role in improving clinical trials by enhancing the quality of data, reaching a more diverse patient population, and increasing retention and access to trials. He shares how medical translation and linguistic validation in clinical research require expertise in medical terminology and cultural nuances of the target language.

Brian talks about how ICON led an industry-wide shift towards insourcing language services instead of relying on external language service providers. Key motivators include cost savings, increased efficiency, faster turnaround times, and the importance of data security and confidentiality.

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Brian explains how the cost of failure in translations is high, as errors can impact patient safety, regulatory compliance, and the overall success of the research. To manage these risks, ICON’s Language Services team implements stringent quality assurance processes, audits, and ongoing training.

When it comes to the EU Clinical Trial Regulation and Clinical Trial Information System, Brian believes it has not had a major impact on language services in terms of volumes. However, the expectation is that over time, these regulations will improve the efficiency of conducting trials in Europe and make the EU more attractive for large-scale clinical trials.

The pod rounds off with Brian’s view on the role of AI in the life sciences market and ICON’s  “string of pearls” approach when it comes to broadening its capability in line with industry trends in the life sciences sector.


Florian: For the listeners who are not familiar with the live sciences, can you just explain in a nutshell, what does ICON actually do? What types of services do you provide?

Brian: In very, very simple terms, ICON, as you rightly point out, is a contract or clinical research organization. And we help our clients to accelerate the development of drugs and devices that help improve patients’ lives in terms of quality of life. So from molecule to medicine, we advance research by providing outsourced services to the pharmaceutical, biotechnology, medical device, government and public health organizations. And we certainly like to believe that we offer the most comprehensive and integrated suite of clinical services in the industry. So our story as ICON is a story of growth. We come from very, very modest and humble beginnings. Started in Dublin in 1990 by five people and as you say, we now employ 41,000 people, over 41,000 people across 50 countries. So we’re a really competent and large force, I guess, within the CRO market and the life sciences sector.

Florian: Quite the story. I didn’t know it was started in 1990 by five people. So it’s a startup and then we’re going to speak about how you grew to that size later on. But maybe can you expand on your role as senior vice president of Commercialization and Outcome services and also for the audience, how is that related to language services?

Brian: I’m extremely privileged to lead the ICO group, as we call it, the ICON Commercialization and Outcomes division. And in very simple terms, within this organization, I would say there are three main or distinct groups. We have our Real-World Solutions team, which is one of the largest real-world evidence and late-phase research providers in the industry. We have a Medical Device and Diagnostics division that’s fully dedicated to device and diagnostics research and that’s a specialized team delivering from consulting to post-approval support. And then I guess most importantly for our conversation today, we have our Patient Centered Sciences group within which our Language Services team and our Mapi Research Trust reside. So Patient-Centered Sciences is, I guess, the divisional name. And within that, we’ve got our language services and Mapi research trust groups.

Florian:  You mentioned before that you’re supporting, for example, big pharma companies when they’re in their clinical trials and we’ll speak about that in a second as well. But can you give us a brief explanation of the clinical cycle, from phase one to four, post-marketing, it’s a very complex area. I remember it from my days back with a language service provider and I was trying to drum up some business among CROs and it felt like I had to do like a mini PhD just to be able to have an informed conversation with the CRO leaders there. So tell our listeners who are not familiar, what is that clinical cycle? What’s phase one to four? What does post-marketing mean and all of that?

Brian: I’ll try to keep it simple. In essence, it is quite simple. So the clinical cycle, also known as the clinical development process, is, think of it as a series of phases that a drug or medical treatment or device undergoes before it’s approved and made available to the public. So broadly speaking, those phases are designed to evaluate the safety, efficacy and dosage of treatment as well as any potential side effects or risks. And broadly it falls into a number of distinct, I would say buckets or phases. So phase one, or sometimes referred to as first-in-man trials, typically involves a small number of healthy volunteers, typically less than 100, who are given the treatment. And the main goal of phase one trials is to assess, I guess, safety, dosage and potential side effects of the treatment so that’s first-in-man phase one, we would then sort of move on to phase two. And the treatment is, broadly speaking, administered to a larger group of patients who have the condition or disease that the treatment is intended to target. And those phase two trials focus on further evaluating the treatment safety and effectiveness and may also in certain circumstances involve exploring different dosages and treatment regimes. Then we would move on to phase three, a much larger group of participants and patients ranging from several hundred to several hundred thousand, often global studies they’re conducted in multiple locations and are designed principally to gather more comprehensive data on the treatment safety and effectiveness. Phase three: trials compare treatment typically to the existing standard of care where there is a standard of care or placebo and ultimately provide evidence, data for submission to competent authorities and regulatory authorities for the approval of the drug or device. And then after it’s approved, we would move into sort of phase four or late phase which sits within my organization and that’s sometimes also known as post-marketing surveillance or post-approval studies. And those phase four trials occur after the treatment has been approved by the regulatory authority such as the FDA or EMA, to name but a few. And the treatment is actively available to the public. And these trials monitor the long-term safety and effectiveness of the treatment in a larger and more diverse patient population. And sometimes they can also involve investigating new indications or use for that treatment. So, that’s a very whistle-stop tour as to the four principal phases and we certainly think across the entire drug or device development process from phase one to phase four ICON has an enormous scale competence and capability as one of the world’s leading CROs.

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Florian:  You’re supporting that process on behalf of the big pharma companies who actually own the molecule, I guess for lack of a better term, right? I mean, Icon doesn’t own that kind of fundamental IP and the molecule but you’re providing all kinds of essential support services around that development cycle.

Brian: You’ve got that exactly right. We don’t own any drug or device ourselves. We simply, I would say, support our customers to develop that product, that device, that drug from early phase right through to post-marketing.

Florian:  Of course, that’s a huge undertaking and comes with a lot of documentation and regulatory compliance, etc. And where these language services come in? Who are the people that require it, buy it and use it?

Brian: It’s utterly synergistic to our ICON customer base, which is ICON principally serves the pharma, biotechnology, medical device and government and public health organization within, I guess, the very generalized context of life sciences. So that customer base for ICON reflects the same customer base for ICON language services. And it’s probably worth pointing out at this stage that our language services team’s sole focus and specialization is obviously within that life sciences vertical. We’re consistently and constantly looking at better ways of running clinical trials to deliver better quality data, to reach a more diverse patient population and to increase retention and access to clinical trials. And our language services team directly supports that goal. So clinical development is global in nature and supporting participants and patients with language and culturally appropriate materials is, I guess, fundamental and critical to the success of clinical trials. So there’s a huge amount of synergy between Icon language services and the other services that we provide to our sponsors all within that specialization of life sciences.

Florian:  Then you said increased retention like supporting participants. Is that the big bulk of demand, like basically informing people that are involved in these trials? Or is there also a lot of just simple or complex regulatory documentation that requires language services?

Brian: It’s a great question and it’s certainly a mix of both. So I guess a very short way of thinking about this is that language services and that capability is simply ubiquitous. So medical translation and linguistic validation, they play a crucial role in clinical research, especially in those sort of phase three trials, those multinational or international studies where participants and researchers come from different linguistic backgrounds. So you touched on a few of those examples patient-facing material or regulatory submission. But I guess a few key areas where medical translation is essential in clinical research probably ranges from informed consent forms. So that’s a really good example of patient-facing material, a fundamental ethical requirement for the research we do. And it’s critically important that our patients understand the purpose, risks and benefits and procedures of a study before they give their consent to participate. So that must be accurate and comprehensive. That’s one example study materials and protocols, including our clinical outcome assessments, case report forms, study protocols, they need to be translated to ensure that we enable accurate data collection and a standardization across multiple language groups. And as you mentioned, other sort of patient recruitment and communication material, effective communication with our patients is critical, is really crucial, I guess, throughout the clinical research process. So translating those educational materials, those participant recruitment materials and study-related communications into the native language helps facilitate understanding and engagement and adherence to the overall study design and requirements. So I guess, that’s a very top line of some examples where our ICON Language Services team support our customers in clinical and device research. But probably more important to note that medical translation and linguistic validation goes way, way beyond mere language translation, to your earlier point. It really requires in-our-domain expertise in both medical terminology and the cultural nuances of the target language. So that specialization and subject matter expertise for our industry, for life sciences, to ensure it’s accurate and culturally appropriate is absolutely critical, absolutely critical.

Florian:  These experts in the in-house team, can you give us an idea of the size and if is it a contained, distinct unit or is it across a number of different divisions that you have? I think you mentioned before that it’s under patient-centered outcomes but how distinct of a unit is the language services team?

Brian: It’s distinct and ring-fence. So it is a division in its own right within ICON and look within the context of the work we do, words and understanding words really matter when dealing with patients and their lives and the data used to support the approval of drugs and devices on the market. So to answer your question, it is an absolutely distinct unit within ICON, albeit it leverages the broader ICON organization in terms of medical expertise, scientific expertise. So it’s separate but really integrated into the ecosystem of the broader ICON organization. And that’s hugely beneficial to us when it comes to seeking out that specialist therapeutic, medical, scientific knowledge needed to deliver a quality product to our customers and ultimately to our patients, investigators, etc.

Florian:  I was just going to say that’s quite the edge over the smaller, still large LSPs – language service providers that you used to actually have as vendors, probably still have some of them, but traditionally CROs have been among the most, the biggest clients of language service providers. And there’s been this gradual shift over the past five to ten years to insource language services and basically deliver this directly. What prompted this on ICON side? I think you’re not alone in actually doing this among the big CROs.

Brian: Again, another definitely good point in terms of maybe some changes that we see as it relates to even some of our competition, frankly. We do see some other CROs to begin insourcing language and translation services instead of, as you say, outsourcing to external language service providers. Why other CROs are doing it and moving? Look, to that type of modality, I can only guess, but I can speak from an ICON perspective and having built this capability out organically and through M&A over the last 15 to nearly 20 years, I think some critical factors come into play as to why that trend, Florian, may continue. And I guess some probable key areas are probably around cost and efficiency. So insourcing versus outsourcing may sometimes offer some cost savings or increased efficiency to CROs. Probably another key area would be faster turnaround times. In certain situations, CROs may require quick translation for time-sensitive tasks. I’m not saying that can’t be done externally, but having it integrated internally means that it can be actioned really quickly. And confidentiality, data security is another really important facet of our industry. So we’re dealing with extremely sensitive and confidential information, including patient data, protocols, proprietary information. So it may add, certainly in our case, more control over data security and confidentiality. But I guess the key component, certainly in our decision well over 15 years ago, to think about this as a strategic imperative for us was, I guess, that seamless collaboration within a broader sense of delivery to our customers. So certainly from an ICON perspective insourcing language and translation services can foster that closer collaboration between our language services team and our other divisions and specialities within ICON. So we work very, very closely with the clinical researchers, project managers and other key stakeholders to allow for integration of those translation activities within the overall research process. So that collaboration allows us to improve alignment, turnaround and better understanding as to the translation needs within the overall context of the clinical research that is being conducted, including the timelines and delivery targets for it, where we can maybe get a little bit ahead of it and start contemplating earlier our customers needs and expectations and specialization needed to make sure that we fit into the overall clinical development plan and broadly remain, dare I say it, invisible. It feels invisible. And that’s a benefit in many cases and occurs in many cases. But that’s really our goal and that’s where we see the benefit of having this capability internally. And I may postulate as to why others now are moving like we moved 15+ years ago to creating this speciality.

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Florian: How much of a consideration was risk in translation language services, in the clinical setting? It’s probably one of the highest cost of failure areas, right? I mean, if you’re in marketing and app, etc. a failure or a translation error wouldn’t matter that much but in your domain, obviously, it’s very critical. Can you just talk a bit about those risk considerations, how you manage them, how you maybe use certain standards as well?

Brian: You’re absolutely right. The consequences of error are extremely high, I would say, and our tolerance for it is very, very low. So translation and other language services within clinical research do carry that unique risk. And due to the critical nature, I guess, of the content and the potential impact on patient safety, regulatory compliance and frankly, the overall success of the research involved. So I guess due to that sort of high stakes and that within clinical and device research, as you put it, the cost of failure in translations can be really substantial. And dare I say it, that cost of failure doesn’t occur in a vacuum. Any error, it doesn’t just affect ICON language services, it affects ICON as an overall organization and a preeminent industry leader. So for us, the stakes are really high. So quality, quality, quality is absolutely critical for us. And we manage this, I guess, as mentioned previously, by, frankly, staying in our lane, we have no interest and we solely focus on expertise in the medical and clinical research domain. We don’t stray outside of that. That’s our specialty, that’s our focus and we couple that with stringent as others do quality assurance processes and audits and ongoing training and professional development within our team. But we would consider, because we sit in that CRO environment and because of that risk, we’re quite regularly and frequently subject to the controls that exist within a CRO, which again have to be, dare I say it, highly, highly robust. So our language services capability is subject to those quality assurance audits, that oversight from a very, very sophisticated and large quality assurance organization, global risk and compliance organization. So it does attract a fair degree of scrutiny, rightly, as to ensure that our services and our delivery is up to the standard expected from a preeminent and leading CRO, as well as, I guess, some of the other table stakes like ISO certifications, etc., that we would obviously have as it relates to our capability. But broadly speaking, that’s how we manage this for you.

Florian: Some other players would issue press releases about this and wouldn’t consider table stakes, but in your case it is. Can you share anything around linguistic validation? It’s one of the services that a lot of the rest of the industry keeps hearing, keeps thinking that it might be attractive to get into, but doesn’t fully understand the complexity. I’m not sure how deeply involved you are in linguistic validation, but maybe just a high-level overview of what it is and how it fits into your overall offering?

Brian: It’s really, really critical to our overall offering because, again, it’s critical to our sponsors and our clients as it relates to the data they collect using COAs. So it’s a critical process. Linguistic validation is a critical process in the development and adoption of clinical outcome assessments to, broadly speaking, ensure that their linguistic and cultural equivalents across different languages and cultures is broadly the same. So I should probably maybe just step back a little bit and explain that a COA or a clinical outcome assessment, they’re measures used to assess patient-reported outcomes such as symptoms, quality of life, treatment satisfaction in clinical research and in healthcare settings. So think of it as the voice of the patient that sometimes can be used as a primary and or secondary endpoint in submission to competent authorities to get a drug or approved or on the market. So the voice of the patient is possibly maybe the simplest way we should think of that. And in terms of linguistic validation, it ensures that those measures, those COAs accurately and reliably, are translated while maintaining their conceptual equivalents and psychometric properties across multiple languages and cultures. So it’s a pretty complicated process. And our Mapi Research Trust that fits in Patient-Centered Sciences and our language services team have been doing this for a very, very long time. And we’re instrumental in setting the standards, dare I say it, by which that is now done by the industry at large. A breakdown as to that validation process on some of the key stakeholders involved. You obviously have the translation team. That linguistic validation is conducted by a team of professionals, including translation, linguistic experts and subject matter experts, clinicians, researchers or developers, including the authors of the instrument or the clinical outcome assessment. And we have expertise in both the source and the target language as well as sort of knowledge of the cultural nuances and relevant target population that will use that COA. So, forward translation, we begin with that simple step to translate the COA – qualified translator fluent in both languages, translates it: the original into the target language, and then we would do a reconciliation process. That forward translated version is then reviewed and reconciled by the translation team. And that involves comparing the forward translation with the original COA to address any sort of discrepancies inconsistencies or culture adaptions that’s required. And the goal is to achieve conceptual and semantic equivalence between the original and the translated version. Then we do a back translation and a review and a cognitive debriefing to ensure that, broadly speaking, any discrepancies or issues are identified through Iterative versions and consultations, and that the reconciled version is then subject to cognitive debriefing interviews with representatives from the target population. And that qualitative feedback helps assess the clarity and relevance and cultural appropriateness of the translated co-op. So, I guess, broadly speaking, the key considerations during that LV, or linguistic validation process is to make sure that there’s semantic equivalence or cultural relevance and an equivalent conceptual understanding and linguistic clarity to ensure that the COA and its intended meaning can be understood by our patients across multiple populations without introducing bias or distortion within the data. That’s a very top-line summary, but I would say probably with confidence. That ICON leads the way through the Mapi Research Trust and has one of the most comprehensive libraries in terms of COAs in the industry and that is expertly supported by our language services team as it really is a critical component of clinical research.

Florian: There’s so many other areas in the language industry where you strive to get this type of outcome from a translation or from a localization, but there’s just not the means or the budgets or regulatory need there to actually go into such a detailed process. I mean, the semantic o the other equivalents that you achieve here with this very sophisticated process, it’s just incredible. Very fascinating and complex also from just a language expert point of view, I guess, but that was very well explained. Thanks, Brian. For the regulatory environment, there has been some change over the past two to three years. I don’t know if we have to touch on all of them, but I mean, there was this in the European Union, the EU Clinical Trial Regulation and Clinical Trial Information System that came into effect this year, I think early in January 2023. Have you seen any major impacts from this on the language services side or it’s been business as usual so far.

Brian: I would hope that over time it positively impacts the efficiency by which trials are conducted, obviously within Europe, and I hope it boosts the attractiveness of the EU as a destination for large-scale clinical trials. Submissions are now centralized and are done through that Clinical Trials Information System – CTIS, that EUY database centralizes the management and reporting of clinical trials within EU member states across the EEA. It doesn’t materially impact language services in terms of volumes to your question, Florian, but our hope and expectation for the good of the industry is that efficiency can be gained out of that, i.e. key documents submitted as part of a clinical trial translation no longer maybe require supporting translation unless they’re required by country-specific regulations, e.g. a protocol or investigative brochure or labels, etc. So those to a degree clarify the translation need and scoping process for clinical documents. And if we do see maybe a reduction in the work that we need to do, that will be a very, very welcome move on the part of the industry and something that we would absolutely sitting within a CRO. Fulsomely support as to ensure that we’re efficient in our delivery and we only do that which is necessary and adds value to our customers’ vis a vis the work that ICON does and our translation team support.

Florian:  Has there been something similar in the US recently or not much or in any other key markets, Korea, China?

Brian: Not much and US, for obvious reasons, much less complicated than Europe from a language services perspective, but look constantly, we’re always looking independent even of regulatory changes, ways to improve and make our services more lean and efficient, I would say.

Florian:  I’m not sure how familiar you are with the details of your iTrans translation management system like your in-house TMS, but maybe you can just give us a bit of an intro what it does, I mean, how long it’s been around and how are you using it.

Brian: Just to explain in very simple terms and probably I am not the person you ought to speak to about that. Conceptually, certainly not at an architecture level, but I understand its value to our language services team and ICON overall. So it’s effectively the core project management tool used by our ICON language services group to track and the progress of translation projects and that’s used relatively ubiquitously across ICON overall and externally with customers. So it’s a client-facing application that allows for submission of new translation requests and to review past requests and to review and approve quotes and receive completed translation documents and translation certificates. And it’s also a gateway to our consultant linguists to allow them to receive and accept offers from ICON language staff and submit invoices. And then we can integrate it via APIs internally within our SSU function and the group that would manage study startups so we can have it on their workbench, so to speak. So they’re not going to alternative systems. So that’s the real value, as it were, from an ICON perspective in that we can have it externally facing for our customers and we can put it in the right place that people are ordinarily doing their day job when they’re thinking about what they need, it’s there for them to request from our language services team what they need within the context of the work that they do. So it’s integrated within many, many other systems and core applications within Icon. And for that purpose alone it has been incredibly beneficial to us. I Recruit Talent. Find Jobs

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Florian: Over the past six, nine months since ChatGPT came out, the whole world’s talking about AI and it’s very specific also to the language industry. These are large language models, after all. How are you thinking about the potential benefit of these models on the business as a whole and then maybe for language services in particular? It’s early days, I know, but maybe some initial thoughts.

Brian: I think, to be blunt, it will play an increasingly important role in terms of the market overall that’s beyond doubt or contestation and is already playing a role in language and translation services within ICON and is likely to be an increasingly evolving and growing area. I guess, stepping back a little bit, what will remain of substantial and significant importance to us, even more so in the clinical and device development setting, is linguistic validation as we’ve just been through and ensuring that appropriate materials have a correct review and a validation by an expert. And there is no doubt that it will help ICON and many, many other LSPs to improve timelines for content and remove repetitive and limited-value add activities. So I see that trend as, broadly speaking, unstoppable. And it’s just going to continue and it’s one that we collectively ICON and the industry need to embrace.

Florian: On M&A, just briefly before we finish, you’ve acquired a lot of companies, including in the language space. I think I remember when Slator started seven, eight years ago, it was Mapi, right, that he acquired. Where do you see M&A fit in your language services strategy and any potential implications for the next two to three years?

Brian: We certainly did acquire Mapi and more recently have made other substantial at an ICON-level acquisitions. And what I would say is our focus is primarily on driving strong organic growth by making sure that we’re serving our customers efficiently and effectively. That’s bucket a really important and then, I guess in a sort of string of pearls approach, we’re always considering where the industry in our very, very specific vertical life sciences is going and what their future needs are. And we’re definitely looking in this space to broaden our capability in line with those industry trends as we would likely project into the future. So probably more to come on that. But it’s an area of, I would say heightened and constant focus for us in terms of what we need to acquire to make sure that we’re ahead or keeping pace with the trends we see in the life sciences industry.