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

Chart Review and EMR Extractions in RWE Research

Two primary methods used to gather data for Real World Evidence (RWE) research are chart reviews and Electronic Medical Record (EMR) extractions.   Chart Review involves manually extracting data from patient medical records, including both paper-based charts and digital documents. This method provides a rich source of detailed clinical information.   EMR Extractions involve the… Continue reading Chart Review and EMR Extractions in RWE Research

Standards of clinical research and reporting

Selecting the appropriate study design is crucial for the effective execution of clinical research. Researchers can choose from a variety of study designs within two main categories: observational and interventional studies. Each design offers unique strengths and weaknesses, and understanding these limitations is essential for drawing accurate conclusions. Observational study designs, also called epidemiological study… Continue reading Standards of clinical research and reporting

Leveraging Real-World Data: Enhancing Drug Safety in Clinical Practice

In the realm of healthcare, ensuring patient safety is paramount. As new drugs are developed and introduced into the market, it becomes imperative to monitor their safety and efficacy beyond the controlled environment of clinical trials. This is where real-world data (RWD) steps in as a powerful tool, offering invaluable insights into the safety profile… Continue reading Leveraging Real-World Data: Enhancing Drug Safety in Clinical Practice