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Reading Time: 2 minutesGenerative (gen) AI is transforming industries, reshaping how organizations operate and how people work. While this technology brings immense opportunities, it also presents challenges that demand thoughtful exploration. Its full potential is just beginning to unfold, offering both innovation and disruption. In many fields, there’s concern that AI might replace jobs. But gen AI thrives […]

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Reading Time: 2 minutesIn oncology clinical trials, accurate and reliable imaging is pivotal in assessing treatment response and disease progression. Computed tomography (CT) scans, in particular, are widely used for their ability to provide detailed cross-sectional images of the body. But the value of CT imaging is only as good as its quality. Ensuring the quality of images […]

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Reading Time: 3 minutesHeraclytus of Ephesus (fl.c. 500 BCE) said, “The only constant in life is change.” But throughout history, there have been periods when that change has been momentous. In just thirty years, we’ve seen unprecedented technological, societal, and business transformations; and we’re about to take another giant leap forward. An example of transformative change is the […]

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Reading Time: 5 minutesAdopting a modern approach to the audit trail review (ATR) process is more important than ever. Continue reading to learn why audit trails are important, explore several use cases, and discover how generative AI can be instrumental in overcoming the challenges of conducting ATRs within today’s complex clinical trial landscape. The Purpose of Audit Trail […]

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Reading Time: 2 minutesIn the fast-paced world of clinical trials, managing patient randomization, drug supply, and site logistics can be a complex challenge. That’s where interactive response technology (IRT) comes in. IRT plays a critical role in ensuring that clinical trials run smoothly and comply with regulatory requirements. But what is IRT, and how does it fit into […]

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Reading Time: 2 minutesEnsuring data integrity in clinical research is essential for regulatory compliance and producing valid study results. Protocol deviation remains one of the most significant challenges, potentially undermining study credibility, impacting patient safety, and delaying regulatory approval. While clinical data management is not directly responsible for protocol deviations, it plays a crucial supporting role in identifying, […]

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Reading Time: 3 minutesClinical research is taking another major leap forward. For decades, drug development relied on in-person, site-based clinical trials as the gold standard for gathering safety and efficacy data. Today, as our global clinical trial ecosystem evolves—shaped by digital health technologies, patient centricity, and the urgency accentuated by the COVID-19 pandemic—this traditional model has shifted. Decentralized […]

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Reading Time: 3 minutesEffectively and accurately measuring disease progression in central nervous system (CNS) diseases, such as multiple sclerosis (MS), is complex and challenging. MS generally presents with a wide range of motor, cognitive, sensory, and visual impairments which can vary greatly between individuals over time. Adding to the difficulty are traditional clinical assessments that often rely on […]

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Reading Time: 4 minutesClinical trials are the building blocks of modern healthcare. The eczema ointment within reach in your bathroom cabinet, the antiretrovirals that allow people with HIV to live long and healthy lives, and the various treatments giving hope to patients across the globe—these are all the result of careful testing to make sure they’re safe and […]

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Reading Time: 5 minutesThe International Council for Harmonisation (ICH) is standardizing drug and medicine development for greater safety and efficacy. Good Clinical Practice (GCP) guidelines for the industry date back to the 1990s, and there was an update to these in 2016. But this third revision (R3) is a real modernization of the guidelines as we know them […]

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Reading Time: 3 minutesManaging essential trial documentation efficiently and compliantly is paramount in the fast-evolving world of clinical research. The electronic trial master file (eTMF) has emerged as a transformative solution, revolutionizing how clinical trial records are stored, managed, and accessed. Unlike traditional paper-based trial master files—which require manual effort and physical storage—the eTMF digitizes the entire process […]

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Reading Time: 6 minutes“Alzheimer’s is the cleverest thief, because she not only steals from you, but she steals the very thing you need to remember what’s been stolen.” – Jarod Kintz1 For patients living with neurological or neurodegenerative disorders, memory loss is a devastating erosion of identity. Diseases that affect the central nervous system (CNS), like Alzheimer’s, chip […]

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