The concept of digital twins has gained significant attention in recent years, revolutionizing industries such as manufacturing, urban planning, and increasingly, and healthcare. A digital twin is a virtual replica of a physical object, system, or process, enabling real-time monitoring, simulation, and analysis. By creating a digital version of something in the real world, industries… Continue reading Digital Twins in Healthcare: Unlocking Potential and Overcoming Challenges
Tag: Methodology
Integrated Evidence Generation Strategy for Rare Disease: A Comprehensive Approach Across Clinical Phases
Developing an integrated evidence generation strategy for a rare disease requires careful planning, cross-disciplinary collaboration, and adherence to regulatory guidelines. The strategy should be holistic, incorporating real-world evidence (RWE), clinical trials, and patient-centric data to address the unique challenges associated with rare diseases and to support regulatory approvals, market access, and ongoing patient care. … Continue reading Integrated Evidence Generation Strategy for Rare Disease: A Comprehensive Approach Across Clinical Phases
RWD for EMA Regulatory Submissions: Differences in Use for Pre- vs. Post-Approval
Real‐world evidence (RWE) has an increasing role in both pre-, and post- approval applications to support the authorization of new medicines and indications, or to address post-marketing safety concerns. Therefore, the use of Real-World Data (RWD) in regulatory processes at the European Medicines Agency (EMA) varies depending on whether it is being used for… Continue reading RWD for EMA Regulatory Submissions: Differences in Use for Pre- vs. Post-Approval
EMR to EDC Integration: Applications, Challenges and Operational Considerations
EMR to EDC Integration refers to the process of transferring data from Electronic Medical Records (EMR), which are used in healthcare settings to maintain patient health records, to Electronic Data Capture (EDC) systems, which are specialized databases used in clinical trials to collect and manage study data. This integration aims to automate data transfer, enhancing… Continue reading EMR to EDC Integration: Applications, Challenges and Operational Considerations
Converting Unstructured Data into Structured Data from EMR: Challenges and Solutions
Discover the challenges and solutions in converting unstructured data into structured data from Electronic Medical Records (EMRs). Learn how Natural Language Processing (NLP), standardized terminologies, and data integration tools can help overcome these obstacles, ensuring accurate and efficient data extraction for improved healthcare outcomes.