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Harnessing AI in Pharmacovigilance: Insights from World Drug Safety Amsterdam 2024

Introduction In the pharmacovigilance space, the overwhelming trend in the current landscape is data overload. Increasingly unmanageable volumes of information pose a core challenge for today’s pharmacovigilance professionals. While digital transformation and new technologies...
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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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Where to Apply Machine Translation in Life Sciences Content Workstreams Right Now

In the life sciences industry, it’s increasingly essential to reduce cycle times and enhance operational efficiencies, especially across clinical and commercial team processes. To address evolving regulations from global health authorities and the common pain points of costs,...
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The Imperative of Accurate Translations in Clinical Research

With the increase of global clinical trials, clinical documentation is required to be accurately translated at every stage from lab to launch. Despite the administrative burdens and tight regulatory timelines that clinical teams face, accuracy cannot be sacrificed in life science...
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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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Implications of AI in Healthcare and Life Sciences: Ethical Considerations in the Age of AI

Artificial intelligence (AI) models have already shown transformative potential in the life sciences industry, including automating administrative clinical research tasks, analyzing patient data to predict future health risks, synthesizing medical information, and more. ...
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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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Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up.  It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance,...
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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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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...
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Navigating the Bias Challenge: Medical Data for Ethical AI in Life Sciences

From drug discovery to personalized medicine, AI systems are broadly transforming how we approach health and disease. The clinical development life cycle generates enormous volumes of data, and its potential is fully realized through the strategic application of AI tools, such as...
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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...
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ICH E6(R3): Understanding the Updated Good Clinical Practice Guidelines (GCP) and Their Future Impact

The International Council for Harmonization (ICH) announced revisions to its Good Clinical Practice (GCP) guidelines, marking a significant move towards more closely aligning clinical practice with the rapidly evolving technological landscape.   The purpose of the ICH...
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The Role of Artificial Intelligence (AI) in Clinical Outcome Assessments (COAs)

Written by Mark Wade, Global Practice Leader, COA SME. Abstract  Artificial Intelligence (AI) is the new frontier for content creation, reuse of language assets; saving time and effort in the curation of documentation. The widely adopted generative AI tools, such as ChatGPT...
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Five Essential Roles Artificial Intelligence Plays in Medical Writing

In the biotech and pharmaceutical industries, the importance of effective communication cannot be overstated. With a responsibility to accurately convey critical scientific findings, regulatory updates, and patient information1, the pressure is on medical writing teams to develop...
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Maximizing Learning on a Budget: 3 Cost-Effective Strategies for Clinical Education and L&D in Medical Device Companies

Are you struggling to provide high-quality training to your clinical education and L&D teams while keeping costs low? As the medical device industry continues to evolve and grow, it’s more important than ever for medical device companies to invest in learning and development ...
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Patient Recruitment and Inclusivity - The Patient Perspective

In the third installment of our annual series of C3 Summits which took place in London on September 13, we invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens...
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Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology

Introduction The question of leveraging digital technologies in rare disease studies with smaller patient cohorts is not one of ROI, but rather data integrity. When compared with traditional paper-based patient reported outcomes (PROs), data integrity is much more easily...
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Anticipate Your Language Needs: The Ultimate Clinical Trial Translations Checklist

“Content is king” is cliché marketing jargon, but in clinical product development, the cliché holds true. Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and...
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Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials

Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers, and...