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Generative AI in Clinical Development

Reading Time: 5 minutesArtificial intelligence (AI) has become quite the buzzword over the past couple of years, and for good reason. We’ve seen significant advances both in how compelling AI can be – from writing a bedtime story to composing a tweet – and the impact it can deliver in almost every sector, from driving cars to providing […]

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Addressing Data Privacy Concerns in Clinical Development with Synthetic Data

Reading Time: 2 minutesThe benefits of implementing AI into the clinical trial process are promising—potentially mitigating prevalent concerns surrounding data privacy and protection. In traditional clinical trial settings, companies are understandably hesitant about sharing clinical trial data due to the fear of violating patient data privacy or any of the strict data protection laws. It’s widely known and […]

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What’s Driving the Adoption of Clinical Trial to Real-world Data Linkage?

Reading Time: 4 minutesThe clinical trial landscape has become increasingly complex, resulting in fewer study starts, longer approval timelines, and greater budget cuts—ultimately challenging organizations to do more with less. Discover why sponsors are adopting data linkage to tackle the challenges of longer timelines, complex trials, and high costs in clinical development—and learn how linking clinical trial data […]

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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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