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Explore the evolution of the FDA decentralized clinical trial (DCT) guidance, highlighting key updates on responsibilities, data variability, inspections, and trial design. Whether you are a sponsor, investigator, or industry professional, this article delivers valuable guidance on navigating the evolving landscape of decentralized clinical research.
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The seamless and secure sharing of electronic health data across systems is essential for improving patient outcomes, driving clinical research, and enhancing healthcare efficiencies. Explore healthcare data interoperability and its role in reducing redundant processes, enabling real-time data sharing, and supporting informed decision-making.
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Learn more about the shift from traditional 100% SDV/SDR to risk-based monitoring (RBM) and risk-based quality management (RBQM) approaches. This white paper details the inefficiency of complete SDV, regulatory trends, and the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV to enhance trial efficiency, data integrity, and cost-effectiveness.
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The confusing world of AI is clarified when you listen to this webinar explaining how to evaluate and operationalize the adoption of AI applied to clinical data management tasks. Watch to learn the "5Es" of AI; how AI can be applied to clinical data management and quality tasks with use cases and a framework; and the additional considerations and challenges of using Generative AI.
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Electronic Clinical Outcome Assessment (eCOA) has transformed data collection in clinical trials by prioritizing patient engagement and improving data accuracy. eCOA leverages digital platforms to enhance compliance, reduce errors, and streamline study workflows. This shift aligns with the growing emphasis on patient-centric research, ensuring that patient voices are effectively integrated into clinical outcomes.
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This Everest Group report examines Medidata’s Rave Electronic Data Capture (EDC) and its impact on the clinical development value chain of life sciences. Learn more about: Rave EDC’s position and growth in the EDC market; changing market dynamics and emerging trends; Rave EDC’s capabilities and case studies.
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