Next-Generation Sequencing (NGS) is a technology that allows the rapid sequencing of entire genomes, targeted regions, or specific sets of genes. It represents a significant advancement that enables the parallel sequencing of millions of DNA fragments simultaneously. NGS can be used for a variety of applications, including whole-genome sequencing (WGS), whole-exome sequencing (WES), targeted gene… Continue reading The Evolving Integration of NGS Data into EMRs: Transforming Clinical Research and Precision Medicine
Category: Methodology
Leveraging Natural History of Disease Studies for Integrated Evidence Generation Plans and Regulatory Success
Natural history of disease studies are intended to track the course of a disease by identifying demographic, genetic, environmental, and other variables (e.g., treatments, concomitant medications) that correlate with the disease’s development and outcomes. Natural history of disease studies play a crucial role in integrated evidence generation plans, especially for rare diseases and conditions where… Continue reading Leveraging Natural History of Disease Studies for Integrated Evidence Generation Plans and Regulatory Success
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
Secondary and Primary Data Integration in Clinical Research
Secondary data are data that have been originally collected for purposes other than a specific research question. This includes data from sources like electronic medical records (EMRs), medical claims data, product or disease registries, and other digital health technologies. Secondary data are often used in pharmacoepidemiological research to evaluate the safety and effectiveness of medicines… Continue reading Secondary and Primary Data Integration in Clinical Research
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