BURG Translations Blog

EU Clinical Trial Regulations

Top 4 Ways the EU Clinical Trial Regulations Will Impact the World

The way we conduct clinical trials in the European Union (EU) will experience a significant transformation when Regulation (EU) No 536/2014 goes into full effect in late January 2022. In May 2014, the EU officially published this new regulation. It was to replace the EU directive No. 2001/20/EC. However, technical difficulties with the new database delayed the launch, and the European Medicines Agency (EMA) pushed back the timeline.

In July of this year, the European Commission announced that the Clinical Trials Information System (CTIS) is fully functional, based on an independent audit of the new system, and will go live on January 31, 2022.

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Stop by to see us at ADRP 2021 Annual Conference

Stop by to see us at ADRP 2021 Annual Conference

 ADRP 2021 Annual Conference Are you planning to attend the upcoming ADRP 2021 Annual Conference, August 17-19? ADRP 2021 Annual Conference is the must-attend event of the year for the blood industry.

Why government agencies need language translation services

Why government agencies need language translation services

As the limited-English proficient (LEP) population continues to grow, so has its linguistic diversity. As of 2018, a whopping 67.3 million U.S. residents spoke a language other than English at home, nearly triple the number in 1980. And when it comes to school children during the same time period, 22.5% of them didn’t speak any English at home. As a melting pot of diverse nationalities and languages, government agencies have an obligation to deliver public services in a way that all citizens are able to easily understand and comprehend – making language translation services critical.

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Waterfall vs. agile vs. continuous localization: Which one should you use and why

Waterfall vs. agile vs. continuous localization: Which one should you use and why

You may have heard the terms waterfall localization, agile localization, and continuous localization, but do we really know what they mean? The common thread between each of these terms is that they are mainly used to describe translation and localization processes for international audiences. That being said, there are significant differences between the three such as different translation project management models or methodologies. Let’s take a closer look at the definitions of these localization terms.

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Here’s how to ensure your multinational clinical trials meet international guidelines

Here’s how to ensure your multinational clinical trials meet international guidelines

With an estimated market size of USD 44.3 billion in 2020, the global clinical trials market is expected to reach USD 69.5 billion by 2028. This exceptional growth is primarily attributed to the increasing prevalence of chronic diseases, the growing demand for clinical trials in developing countries, the adoption of new technology, and the COVID-19 pandemic. As we look to the future of this highly regulated market, globalization of clinical trials, continued technological advancements, and the rising demand for Clinical Research Organizations (CROs) to conduct clinical trials are expected to further fuel its growth. 

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