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AI Technology: The Future of Advanced Analytics in Clinical Trials

Reading Time: 5 minutesOver the last few decades, the stream of data available to life sciences companies has grown from a trickle to a tidal wave: genetic and genomic portraits of individual patients, metabolomic and proteomic profiles, real-world data from wearables measuring everything from heart rate variability to blood glucose levels, and detailed patient clinical histories from electronic […]

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Clinical Trial Site Selection: How to Improve Your Process

Reading Time: 2 minutesIdentifying high performing sites for a clinical trial is a crucial step in the study feasibility stage to make sure trials remain on their targeted timeline. However, it’s often difficult to confidently identify the best sites for a trial purely based on anecdotal experience or limited historic performance data. With real-time, industry-wide, site performance data, […]

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Diversity in Clinical Trials: FDA Draft Guidance on Diversity Action Plan Requirements

Reading Time: 3 minutesThis blog was authored by Ashni Parekh, Global Compliance and Strategy Analyst at Medidata. The topic of diversity in clinical trials has received much attention from the FDA over the past few decades, but this wasn’t always the case. In 1977, the FDA recommended that women of childbearing potential be excluded from clinical trials, due […]

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Medidata Presents Research at ASH 2024

Reading Time: 3 minutesBlood cancers make up a large portion of cancer types—these can include lymphomas, myelomas, leukemias, and myelodysplastic syndromes (MDS). There are over 100 different types of blood cancers, highlighting the importance of getting a proper diagnosis and individualized treatment plan into place. Because of the large number of blood cancer types and the increasing complexity […]

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Clinical Interoperability: Everything You Need to Know

Reading Time: 10 minutesWhat Is Interoperability in Healthcare? Healthcare interoperability (also known as clinical interoperability) is the ability to effectively and seamlessly communicate, securely store, and share electronic health data in a timely manner. This allows relevant parties to access full medical histories within the healthcare ecosystem. Ultimately, the goal is to positively impact health outcomes for patients. […]

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The Essential 5 Es for Operationalizing AI in Clinical Data Management

Reading Time: 4 minutesModern clinical trials are accelerating towards increased complexity, with their expanding array of digitized source data coming from a wider variety of sources, decentralized clinical trials (DCT), and adaptive designs. Artificial intelligence (AI) is being used in many innovative applications across the entire drug and device development continuum. It can be broadly categorized into several […]

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Generative AI in Life Sciences: The Challenges & Opportunities

Reading Time: 3 minutesThe potential that generative AI may have on nearly all industries is exciting. Though, like any new technological advancement, there are both challenges and opportunities to understand. For the life sciences industry, the stakes are particularly high due to the sensitive nature of the data and the growing adoption of this technology. Understanding these challenges […]

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Decentralized Clinical Trials: FDA Guidance Analyzed

Reading Time: 4 minutesIn 2024, the US Food and Drug Administration (FDA) issued final guidance on the use of decentralized clinical trials (DCTs), Conducting Clinical Trials with Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties. This new guidance hasn’t introduced radical sweeping changes, but it does acknowledge the DCT practices that have been in place for […]

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Generative AI: The Next Wave

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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The Challenge, the Change, the Solution: Reinventing Medical Imaging

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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From Paper to Digital to Virtual: The Past, Present, and Future of Clinical Research

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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