Electronic data capture is a system that is used to computerize data gathered from clinical trials. EDC can be entirely web based, which means that the software runs primarily on a web server and information can be accessed anywhere. This method replaces the traditional pen-and-paper. Although you may record data collected first-hand by writing it on a sheet of paper, you can encode it afterward into the system to manage the data gathered.
How is EDC beneficial to its users?
Several things need to be considered in order to successfully administer a clinical trial. Without carefully thinking about how to gather the data, results from the trials may become inconclusive. Listed below are the reasons that EDC is useful in conducting clinical trials. Watch the video below for more info on the benefits of EDC:
1. Clinical data management
With clinical trial software, errors would be reduced. Data errors submitted from the investigative office to a biopharmaceutical company could be reduced by up to 70 to 80%. This results to enhanced efficiency and ultimately diminishes the cost of clinical trials.
2. Results are available sooner
Instead of waiting for about 5 to 8 weeks, the EDC system can deliver results in a matter of hours. Enhancing quality and shortening the duration of production are the cores of effective drug development programs.
3. AccessibilityThere is no need to wait for the delivery of data from the investigating center for a week after your request for a copy of the collected data has been sent. Data encoded into the system can be accessed anywhere, so long as you have Internet connection.
The Evolution of Clinical Data Management System
In the early 90s, clinical research organizations (CROs) depend highly on the paper-based approach for collecting the patients data. As a result, processing the trial takes a lot of money and time.
An archaic version of EDC is known as the Remote Data Capture (RDC). This system uses thick client software. This kind of clinical trial management software is installed into the local computer, and is called thick client software. The system would then need to connect to a modem over analog phones that transmit the data back to the sponsor in an interval.
Who uses EDC?
EDC software users can be categorized into 3, namely, CROs, sponsors, and sites.
- CRO - A Contract Research organization (CRO) contracts with sponsors in order to facilitate the planning and execution of a clinical trial. CROs may operate trials in behalf of their sponsor. In some trials, they will only take significant roles such as data management, monitoring, and analysis. CROs are sometimes called Clinical Trial Units, Academic Research Organizations (AROs), or Data Coordinating Centers.
- Sponsor - A sponsor of a clinical trial is the owner of the trial. Many life science companies sponsor clinical trials to get their medical breakthroughs approved by authorities. One of these authorities who regulate the medical innovations of these companies is the FDA. Sponsors have the ability to employ various people who know how and EDC system functions: Biostatisticians who help in planning and analyzing collected data and data managers who make sure the trial data is ready and fit.
- Sites- A site is the entity that gathers the needed data from the clinical trial subjects. These are usually hospitals or clinics. Coordinators, such as nurses and other designated employees, are tasked in encoding the data into the trials EDC system. The sites Investigator, usually a doctor in charge of the patients care and data, is assigned to review and electronically sign the data.
Selecting EDC Tools
It is important to know how crucial eClinical solutions are, and the value that standards are able to provide throughout a process that makes use of multiple modernized technologies. Thus, consideration that instantly come to mind in the process of choosing a technology can be viewed with an eye toward the broader surroundings. Among these considerations include, but are not limited to, regulatory requirements, user acceptance, and cost.
- Regulatory requirements - Regulations that directly apply to EDC and FDAs Computerized Systems Used in Clinical Trials or CSUCT, have been revised over the years. The regulatory community is generally supporting of using EDC tools.
- User acceptance - One of the significant factors to make sure that both site personnel and in-house employees are accepting of the tool is its usability. The seller must provide usability test and, ergo, user acceptance results.
- Cost - Companies usually give out requests for proposal (RFP) to do a cost comparison. It is critical to establish project requirements that allow a credible comparison between proposals.
Although EDC is always the better choice over paper-based systems, there is a reason that the latter is still in use it requires an investment. However, the benefits outweigh the costs.