Thought Leadership
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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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How to Select the Right Regulatory Writing Company for Your Organization's Needs

In a landscape defined by ever-evolving global guidelines from health authorities, many life sciences organizations’ clinical and regulatory teams face challenges in navigating the regulatory affairs writing and document submission process. Adhering to strict rules while...
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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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Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

Author: Maria Arnott and Corinne Shoch, COA/eCOA Licensing Management Team In clinical trials, it is usually necessary for sponsors to obtain permission to use copyrighted materials, such as clinical outcome assessments (COAs). The process to obtain these permissions is called...
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4 Immediate Applications for AI Translation in Pharma

Precision and speed are key facets of success in the dynamic world of pharmaceutical development. To achieve these goals, AI-powered capabilities, such as machine translation (MT), can have a considerable and transformative impact.  Automated translation workstreams enable...