Thought Leadership
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IMP Labeling: EU CTR Transition Considerations

The European Union Clinical Trial Regulation (EU CTR) went live on January 31, 2022. The first-year transition period ended on January 30, 2023, so using the Clinical Trial Information System (CTIS) is now mandatory for all initial submissions of interventional clinical trials...
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Electronic Product Information – Everything You Need to Know

One of the latest initiatives being spearheaded by EMA is publishing ePI, or electronic product information. In some respects, the pharma industry has lagged behind other major industries in terms of how documentation and critical information is relayed to the end patient. Due to...
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Leveraging Artificial Intelligence (AI) in Pharmacovigilance

Expert-driven technologies are continually being implemented into the clinical process to eliminate manual burdens and ramp up efficiencies. AI-enabled automated systems help to remove the barriers that prevent high-quality data and compliance in reporting of clinical events....
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A Comparison Between Document Management Systems (DMS) and Component Content Management Systems (CCMS) for Pharma

CHOOSING THE RIGHT OPTION FOR YOU AND YOUR BUSINESS NEEDS Global pharma companies produce and manage a lot of content that is complexly intertwined. To mitigate risk, ensure patient safety, meet regulatory compliance standards, and reduce cycle times for faster drug-to...
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An Unlikely Perfect Pairing: Life Sciences & Translation

What Is Life Sciences Translation? Let’s first define the term “translation” within a life sciences context. Life sciences translation is the adaptation of clinical documentation and MedTech materials across different languages. While the concept may seem relatively simple, it...
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The Importance of Over-the-Phone Interpretation for Emergency Services

Imagine calling 911 in a state of crisis at the scene of an emergency situation, only to hear the call handler trying to understand you. And there’s nothing wrong with the connection—the poor communication is only because the person doesn’t speak your language.This kind of...