EDC software is a web based application used in clinical trials to help collect, manage and store patient data in electronic format. It replaces the previous systems of data collection by means of paper based documents and in this regard it is more efficient and reliable in terms of clinical trial data management. EDC software is used for:
Data collection: Assists researchers to key in data into electronic Case Report Forms (eCRFs) thus enhancing efficiency and decreasing the possibility of errors.
Data validation: It has built in checks for errors and gaps, thus enhancing the quality and completeness of the data.
Real time data access: It enables quick access to trial data this makes it easier to make quick decisions and come up with analyses.
Integration: Some EDC systems can integrate with other clinical trial technologies, which allow for automatic data transfer from different sources.
Data security: It has stronger measures to secure the data collected to ensure that it is not lost, altered or tampered with.
Regulatory and compliance: EDC systems assist in the meet up of the regulatory requirements such as 21 CFR Part 11.
The application of EDC tools in clinical trials may enhance the velocity of the trials, decrease costs, increase the quality of the data and, therefore, the speed of development of new drugs.
