In the January edition of Multilingual, Acolad Life Sciences experts Daniela Rughetti and Stephane Millet shared their views on the new language planning challenges faced by clinical research organizations regarding the new guidelines for clinical trial submissions.
In early 2023, the EMA (European Medicines Agency) implemented its new, centralized Clinical Trials Information System (CTIS) meant to streamline the submission, assessment, and approval of clinical trials across multiple EU markets. Since then, all new life sciences clinical studies conducted by or for organizations with sites in one or more EU countries must be submitted through the CTIS.
While there were clear benefits to the change, it also translated into tighter deadlines and a number of new challenges, especially for the localization part of the process – which was often left to a later stage. The new centralized procedure entails channeling all steps and stages through a single EU member state, meaning that usually a single language service provider (LSP) is designated, under the assumption that resources and expertise are available and a quick turnaround is ensured.
That not always being the case and the need to factor in translation/language expertise much earlier in the process becoming evident, Acolad’s Daniela Rughetti, Strategic account Account Manager, and Stephane Millet, Director for Strategic Accounts and Patient Engagement Lead, discuss how language planning in clinical trials can be an invaluable aid in expediting and democratizing patient access to drugs, therapies, and vaccines in a recent article published by Multilingual.
“At Acolad we firmly believe that ensuring an open dialogue with your language services provider is key to stay ahead of all these developments and ensuring the highest quality outputs,” said Daniela Rughetti, “The process can be quite overwhelming if you don’t plan it out, and consider all elements, including translation and localization, so partnering with the right provider to optimize your processes is fundamental.”
“And, of course, having it all planned out, and working with a provider whose expertise you trust, who has the resources to guarantee 24/7 service and full understanding of local and global regulations, will allow organizations to totally focus on the patients and their needs,” concludes Stephane Millet.
Acolad Life Sciences is the division within Acolad dedicated to certified language solutions for pharma, medical devices, medtech and clinical research organizations. Supported by the unmatched expertise of its medical translators and technology-driven language solutions, Acolad Life Sciences partners with clients through every stage of product development - from clinical trials to post-market surveillance - ensuring adherence to industry standards and regulatory requirements of national and international health authorities worldwide.
Recently, Acolad launched its innovative Clinical Center of Excellence, specializing in culturally relevant translations of patient-facing and clinical trial documents. By meticulously translating and adapting critical medical documents for clinical trials, Acolad's Center of Excellence ensures accuracy and respect for diverse languages and cultures.
You can access the full article here and read more about how Acolad partners with pharma, medical device and clinical research companies here.
Acolad is the global leader in content and language solutions. Its mission is to support companies in every industry to scale across markets and enable growth through cutting-edge technology and localization expertise. Established in 1993, the group is present in 25 countries across Europe, North America, and Asia, with over 2.500 employees supported by a network of +20.000 linguists around the world.