EMA releases updated QRD Style Guide– say no to “drugs”

The European Medicines Agency (EMA) is responsible for evaluating, supervising, and monitoring medicines for safety– its mission is to foster scientific excellence in the assessment and management of medicines in the EU. Committed to providing clear and unbiased information, the EMA employs a variety of regulatory mechanisms that are continuously evaluated and optimized for the benefit of the public.

The EMA recently published its compilation of Quality Review of Documents (QRD) decisions about the stylistic guidelines in product information– citing frequent translation issues and providing additional policies that directly impact multilingual labeling and packaging. 

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Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference

Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021?

The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational challenges and innovations in clinical development. This year’s event will feature a keynote talk from Ken Getz, Associate Professor at Tufts University School of Medicine as well as leaders from companies such as Novartis, Sanofi, Pfizer and AstraZeneca and others.

Dates: November 9 – November 10, 2021
Location: The Westin Boston Seaport District, Boston, MA

We’ll be there as well, so let’s connect!

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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

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.

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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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Freelance translators vs. an LSP: What you need to know

What do you think of when you hear the term “freelancer?” If you’re like most people, the first thing that comes to mind is a one-person company with no overhead costs to pass on to you. And while this is true, there are a few things you should consider before hiring a freelancer to translate your life sciences or legal documents.

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How to successfully incorporate translations into your workflow

More often than not, you need important documents translated yesterday. Unfortunately, rushing translation won’t net you the best results. So what’s the answer? You need to ensure that translation is part of the overall process, and this means building it into your workflow. By including translation into your overall workflow you’ll be able to manage expectations better, ensure quality, and receive high-quality translations everytime.

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Six steps that will optimize your medical device marketing

If you’re a marketer, you know that there are many challenges in delivering a successful marketing campaign. Your goal is to engage your target audience by providing the content that’ll make them want to buy your product. And, when you’re marketing a medical device in other countries, the process is riddled with even more obstacles. 

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Grow business by partnering with a language service provider (LSP)

On any given day, the economy of a single nation or across many nations fluctuates. Similarly, business growth also fluctuates and can become stagnant. To stabilize revenue streams and grow the business, many organizations diversify by taking their product(s) or services across international boundaries.  

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Life sciences translations: Critical success factors

Within the life sciences industry, ensuring the highest quality of a translation can’t be underestimated. To minimize even the remotest possibility of a mistranslation, every component of the translation process needs to be optimized.   Read more