Category: Regulatory

medical translation

The impact of language errors in clinical trials can be significant, leading to confusion for the participants and researchers. These frustrating events can lead to dropouts, delays in execution timelines, and even affect the validity of the ultimate trial results. Because of this, regulatory agencies now require that global clinical trials are accurate, consistent, and culturally appropriate in each of the local countries they are administered.

Investing in high-quality transcreation services can be a major differentiator for a successful clinical trial, by ensuring regulatory compliance and improved patient outcomes.

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What is The GDPR? The General Data Protection Regulation (GDPR) is an EU regulation that sets more stringent rules to improve data protection and privacy for all individuals residing within the European Union. GDPR was approved on 24 May 2016, and gives all organizations until 25 May 2018 to fully comply with the new legislation. Does … Learn More

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After over 40 years of negotiating, a single European patent system has been developed that makes protecting intellectual property (IP) easier, more efficient and cost effective. This new system will grant one patent to cover the 25 countries that are joining and endorsing the new system. This Unified European Patent system reduces translation requirements and maintenance … Learn More

ce marking translation

This year Croatia becomes the 28th EU member state to require CE Marking. This means that manufacturers will be able to place products, devices and machines on the Croatian market, but those items must have documentation in the Croatian language. After reading the above sentence you may find yourself asking, “what is CE marking, and what … Learn More

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On October 1, 2012 the US Federal Transit Administration (FTA) and Department of Transportation (DOT) finalized and released Circular 4702.1B which clarifies and explains guidelines for Title VI language and translation requirements. Previously the DOT language requirements were confusing. Some transportation agencies did not understand that the language requirements applied to them. To address the … Learn More

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This blog on Pharmacy Language Requirements rightfully belongs to our subsidiary RxTran, but since our CEO Brian Kratt is standing today to deliver a presentation on nationwide pharmacy language laws and options for pharmacies to offer language services, I thought it only right to make it my blog topic. Increasingly, pharmacies recognize the mandates to … Learn More

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There is a debate about bringing the language of Informed Consent Forms (ICFs) down to a level that is more universally understandable. If English speakers struggle to understand the language of Informed Consent Forms, imagine the difficulty that exists for people with limited English proficiency (LEP). The US Food and Drug Administration (FDA) (21 CFR … Learn More

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You may not have thought of it, but if you are localizing or translating your website and digital content, you may need to keep it Section 508 compliant. With over 20% of web users that have some disability, Section 508 compliance can help you reach up to 20% more of your target audience that you … Learn More

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It seems a no-brainer that companies with employees that speak other languages would want to provide safety information and warnings to those employees in a language they understand to protect both themselves and their workers. Further, OSHA (Occupational Safety and Health Administration) has revised the Hazard Communication Standard (HCS)to improve safety, standardize hazard information and … Learn More

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Regardless of your views of the Patient Protection Affordable Care Act (often referred to as ACA or more controversially as “Obamacare”), it was passed and is currently in the process of being implemented. Since the Affordable Care Act was intended to cover all uninsured Americans, this law will dramatically increase the number of limited English … Learn More