Thought Leadership
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Transcreation in Clinical Research: How to Use Transcreation and Localization to Resonate with Your Audience

Clinical teams need to communicate with multilingual audiences across the globe while also meeting strict regulatory requirements. In addition to helping teams remain compliant, accurate translations ensure the highest standards of patient safety are met across clinical...
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How Pharmacovigilance Automation Solutions Can Help You Meet Tight Regulatory Reporting Timelines

Pharmacovigilance (PV) teams play a critical role in detecting, assessing, understanding, and preventing the unintended adverse effects of medications and treatments. Their work, which includes drug reaction monitoring, drug safety surveillance, side effect monitoring,...
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How to Improve the Speed and Accuracy of Patient Communications in Clinical Development

According to Phesi, more than a quarter of clinical trials conducted in 2023 were canceled during Phase II.  As clinical research teams struggle with patient recruitment and engagement under tight deadlines and immense regulatory pressure, patients also grapple with...
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3 Ways to Leverage Generative AI in Pharmacovigilance

Despite the rigorous drug safety and efficacy standards in trials, study medicines can have unintended side effects on patients throughout the clinical trial journey and even in the post-market setting. To ensure patient safety and mitigate risk, global health regulatory...
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5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions

Moving a drug from development, through clinical trials, to eventually the market involves many critical content pieces and challenges along the way.   According to research commissioned by Genpact, 72% of senior executives across the life sciences industry cited regulatory...
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How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations

Authored by Pierre-Frédéric Omnes, Executive Director The publication of clinical data has been a focus of public policies and regulations in the European Union (EU) in recent years to avoid duplication of clinical trials, foster innovation, and encourage the development of new...
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Localizing Platforms for Digital Health: The Importance of Post-Localization Context Review

In a landscape defined by continuous technological advancement, many organizations in the life sciences industry strive to increase audience engagement through digital modalities, such as mobile and web applications or web portals. Building a robust technological infrastructure...