Clinical Data Management; Used In Clinical Research to Manage Clinical Trial Data

Clinical data management is a critical process that leads to the generation of reliable, high-quality, and statistically sound data from clinical trials. It is a process of collection, integration, and management of clinical data in compliance with regulatory standards. It is important for clinical trials or procedures and to pharmaceutical and biotechnology companies. This helps in reducing the time taken for drug development. Clinical data needs to be maintained in a standard way to avoid corruption, loss, or alteration of important data. The data collected from multiple sources is captured in a paper or electronic format, and stored in a data repository, in a patient-centric fashion, known as the clinical data repository.


Contract research organizations (CROs) and pharmaceutical companies are involved in clinical data management activities. Clinical data management outsourcing is done by the organizations to focus on core competencies of clinical research and pharmaceuticals, investment in research and development activities, and reduction in operational expenditure. Moreover, clinical data management is the primary means of patient records, which include demographic, clinical, and demographic information, laboratory-radiology information, vital signs, information regarding medications, and trial information such as subject name, the number assigned to each patient, reasons for discontinuation, the reason for withdrawal, etc.

Clinical data management is an important process in clinical studies, which contributes to the generation of reliable, high-quality, and statistically significant data from clinical studies. This makes the sure efficient collection, processing, and distribution of high-quality data. Clinical data management also involves efficient analysis and reporting of collected data. The main tasks of clinical data management are a collection of details about participants, research procedures used, analysis of data, and finally sharing of results with the research team, the physicians, etc. Thus, it is one of the most important roles in research.