This streamlining offers many benefits to stakeholders on all sides. But it also presents new regulatory process challenges. That’s because sponsor/clinical research organizations (CROs) with operations spanning multiple markets are required to bring together all of their submissions-based content in a concentrated, consolidated way and satisfy any follow-up queries (requests for information or RFIs) within a short time window — of just 12 days (all in).
Too often, factoring translation/language expertise is left too late. That now needs to change if the overarching goal of clinical trials transformation is to be assured — expediting and democratizing patient access to important drugs, therapies, and vaccines.
Whereas translations and wider language services were previously accessed on a more ad-hoc basis for submission country by country, the emphasis now is on consolidating everything and channeling it through one reporting EU Member State. Once all of the materials have been collated, the work is then typically fed to a designated language service provider (LSP) on the assumption that the necessary resources and experts will be available to process what can amount to a significant batch of work requiring a fast turnaround.
Staying ahead of the curve
With so many considerations, it’s important that life sciences companies stay ahead of EU-CTR demands. That means having in place optimized processes and maintaining ongoing dialog with providers of language services. This ensures that content throughput and associated deadlines can be anticipated and planned far in advance. Foresight and forward planning will uphold the highest levels of quality — which are crucial for patient safety and engagement — while keeping pace with tight timelines.
Given that regulatory requirements are evolving all the time, having access to focused expertise is important, too, which is a further reason to be mindful and communicative about what is coming up. There may be a specific call for language service experts who understand document redaction requirements, for instance, to protect patient identities and commercially confidential information. Or there may be an upcoming requirement around the specifics of informed consent requirements or plain language summaries. For marketing-type materials used for patient recruitment and engagement, the skills needed are likely to be different again — geared more to hitting the right tone and level of empathy with the required content, as well as all-important message clarity.