CTR's Impact on Localization
In the 8th post of our life sciences series, we’ll discuss the impact of CTR (EU) No 536/2014 on localization. CTR marks a significant milestone in the harmonization of EU clinical trial procedures. Its primary aim is to ensure a more streamlined and efficient clinical trials framework, emphasizing safety, transparency, and data reliability. In Jan. 2023, the Clinical Trials Information System (CTIS) was implemented as the single entry point for clinical trial data and information submission.
Challenges Posed by CTR
1. Increased Complexity: CTR introduces a unified submission portal for all EU member states, which necessitates a higher degree of localization management. Documents must be submitted for multiple jurisdictions simultaneously. In the past, localization was often focused on a single language or a small set of languages. With all languages are required to be submitted at once, more resources are required.
2. Stringent Timelines: With CTR enforcing tighter deadlines for the assessment and approval of clinical trial applications, localization processes must be expedited without compromising quality.
3. Enhanced Transparency: CTR mandates increased clinical trials transparency, requiring public registration and disclosure of trial summaries in plain language. For all Phase 1-4 interventional trials conducted within the EU, trials must be submitted with a PLS. With CTR’s full enforcement, sponsors must submit PLS into the CTIS within 6 months of the trial’s conclusion for pediatric trials and within 12 months for the remainder.
How to Address CTR’s Challenges
1. Standardization and Quality Improvement: Sponsors should work with their LSP’s to drive process and technology harmonization and improvement.
2. Technology Integration: To meet the demands of CTR, sponsors and LSP's should focus on increasingly integrating advanced technologies. These include AI-driven translation tools, translation management systems, and automated QA platforms. The integration between sponsor’s content and LSP’s translation management systems is becoming increasingly critical.
3. Enhanced Focus on Plain Language Summaries: Creation of PLS requires a specific skillset, with deep knowledge around the requirements and intent of these PLS. Education of localization resources providing this service is critical to the success. Resources must focus on delivering PLS with fewer words, at the appropriate reading level, and with critical information at the forefront.
Read the full post here: https://lnkd.in/gg2rVS4R
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