logo
logo
Sign in

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

avatar
CMI Blogging
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.

 

The management involves various activities, which include management of participant details, data quality control, and storage of diagnostic test results, reports on medical treatments and outcomes, billing, data quality audit, etc. An electronic data capture system is one of the important aspects of clinical data management. An electronic data capture system includes a centralized data repository, collection application, desktop computers, etc. It is the most efficient way to store, retrieve, classify, and analyze clinical trial data. The system helps in the timely and correct submission of paper trails for approval and filing of claims. 

collect
0
avatar
CMI Blogging
guide
Zupyak is the world’s largest content marketing community, with over 400 000 members and 3 million articles. Explore and get your content discovered.
Read more