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: Clinical Research
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
Process for Health Technology Assessments (HTAs) in France
Health Technology Assessments (HTAs) in France are a key component of the healthcare system, used to evaluate the clinical efficacy, safety, and cost-effectiveness of new medical technologies, including drugs, devices, and procedures. The HTA process in France is highly structured and involves several key organizations, each with distinct roles and responsibilities. 1. High… Continue reading Process for Health Technology Assessments (HTAs) in France
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