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Reading Time: 3 minutesData linkage—the process of connecting clinical trial data (CTD) and real-world data (RWD) to show a comprehensive view of the patient journey—is shifting the existing paradigm of clinical trials. Whereas CTD and RWD have traditionally existed in silos, a robust data linkage solution helps sponsors overcome these gaps that hinder evidence generation. With a deeper […]

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Reading Time: 2 minutesData linkage—the process of connecting clinical trial data (CTD) and real-world data (RWD) to show a comprehensive view of the patient journey—is shifting the existing paradigm of clinical trials. Whereas CTD and RWD have traditionally existed in silos, a robust data linkage solution helps sponsors overcome these gaps that hinder evidence generation. With a deeper […]

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Reading Time: 5 minutesToday’s clinical trial technologies allow patients to complete clinical trial activities remotely to create better patient experiences while enabling sponsors and clinical research organizations (CROs) to execute faster, smarter trials and sites to focus on patient care, rather than administrative duties. The promise and potential of decentralized clinical trials (DCTs) are great, but execution and […]

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Reading Time: 7 minutesThis blog was written by Sheri Lillis, RTSM Solution Services Principal at Medidata. What keeps you up at night? Or prevents you from falling back asleep? As a Medidata Rave RTSM subject matter expert (SME), there is one nightmare that can keep me up at night, and it can take several forms: Unblinding a patient […]

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Reading Time: 2 minutesMedidata and Imunon Corporation—a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines—published their findings on the use of a Synthetic Control ArmR (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (the OVATION 1 Study) in the American Society of Clinical Oncology […]

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Reading Time: 5 minutes Medidata NEXT New York 2022 was truly special, with hundreds of industry leaders coming together to explore tomorrow’s breakthroughs in life sciences. For the first time in three years, NEXT returned in person to Spring Studios in downtown Manhattan. Check out some of the highlights from the industry’s premier event. Keynote Highlights The NEXT […]

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Reading Time: 4 minutesModern clinical trials continue to increase in complexity as they include more decentralized elements, adaptive study designs, and data originating from multiple sources. Comprehensive data and risk surveillance technologies are now addressing this complexity, helping study teams ensure data veracity and quality across large datasets and supplementing traditional site-based monitoring activities. Conventional monitoring methods—typically involving […]

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Reading Time: 3 minutesSummary After investing years and significant resources in clinical development and R&D, clinical-stage biopharmaceutical companies only have one shot to successfully launch their product. A huge part of setting a company up for success is having access to the right patient-level data and operational data to guide your commercialization decisions. But with over 50 different […]

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Reading Time: 2 minutesThe Medidata Knowledge Hub is a new, state-of-the-art content experience that unifies all customer-facing product knowledge into a single self-service site. Aimed to give our customers a streamlined, connected, and personalized interface, you no longer need to search through the various help and support sites you’ve become accustomed to when using the Medidata Unified Platform. […]

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Reading Time: 5 minutes2022 was a remarkable year for external control arms (ECAs) in clinical trials. Developed by Medidata AI, a Synthetic Control Arm (SCA) is an external control arm derived from both cross-industry historical clinical trial data and real world data. In contrast to other external controls—static summary measures that do not adequately account for patient baseline […]

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Reading Time: 4 minutes Substantial research suggests that patients participating in cancer clinical trials of new therapies are a small and largely unrepresentative subset of the United States (US) population with cancer. Compared to the underlying US population with cancer, patients who enroll in cancer clinical trials are younger, otherwise healthier, wealthier, more often White, and less likely to […]

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Reading Time: 2 minutesClinical trials are constantly evolving in response to technological advances, new data analysis methods, and diverse trial designs, such as decentralized clinical trials (DCTs). One of the significant developments in clinical trial management in recent years is implementing a risk-based quality management (RBQM) framework. The adoption of these approaches is increasing due to their efficiency, […]

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