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

SlatorPod

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.
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.

Chapters

1. Intro and Agenda (00:00:00)

2. ICON in a Nutshell (00:01:18)

3. Role as SVP of Commercialisations & Outcomes (00:02:53)

4. The Clinical Development Process (00:04:11)

5. Language Services at ICON (00:09:02)

6. Shift to Insourcing Language Services (00:15:36)

7. Translation Risks in Clinical Research (00:20:01)

8. Linguistic Validation (00:23:38)

9. Impact of EU Regulations (00:29:47)

10. ICON's TMS (00:32:41)

11. The Role of AI (00:34:58)

12. Growth Strategy (00:36:43)