To streamline the process of collecting, storing, and managing patient data gathered during clinical investigations, medical device manufacturers can benefit from using an Electronic Data Capture system. These days, many EDC systems follow the Software-as-a-Service (SaaS) model of distribution, where they are hosted off-site and are accessed by sites and sponsors via the Internet.
Researchers conducting a clinical trial can use electronic case report form (eCRF) forms designed by the trial’s sponsor using an electronic data capture (EDC) system. Data managers can set up EDC systems with input validation and programming to ensure all data collected is accurate and comprehensive. EDC software lets clinical study managers transfer data to other programs for analysis once enough information has been gathered.
Advantages of using EDC software in clinical investigations and studies of medical devices
- The streamlined data collection process
To streamline data collection throughout the medical device lifecycle, it is recommended to use a software-based EDC system for clinical activities.
Conventional paper-based data collection necessitates researchers filling out CRFs on paper, sending them to the study sponsor, and then having data entry teams enter the information into a database by hand before any analysis can be performed. By allowing researchers to generate data in a digital format using an eCRF, electronic data capture (EDC) systems streamline this time-consuming process.
- An elevated standard of data
One more benefit of using an EDC to gather information for clinical trials is an increase in the reliability of the information collected. Clinical study managers can reduce the prevalence of errors in data entry and transcription by simplifying the previously laborious paper-based data collection procedure. Using the EDC tools, researchers can fix mistakes and inconsistencies in data entry before affecting the study results.
- More easily accessible medical records
Accessibility is another benefit of recording clinical data in an EDC system. After researchers have finished filling out an eCRF, it can be stored in your EDC system and accessed immediately from any location with an Internet connection by anyone with the proper permissions.
Data reviewers no longer have to wait for a box of paper CRF forms to arrive in the mail before they can begin reviewing and analyzing eCRF data. Managers of clinical trials can better spot trends and make educated decisions when they have access to data in near real-time.
- Reduced the cost of running hospitals
The overall expense of medical trials can be minimized by using an EDC system to collect data. EDC systems cut down on the total data collection and analysis cost by simplifying the process, using automation to ensure high-quality data, and minimizing the need for data cleaning and preparation.
By shortening the time it takes to conduct clinical trials, medical device manufacturers will have a much easier time gaining approval to sell their products and, ultimately, making a profit.
Conclusion
By using Electronic Data Capture, businesses can get off to the right start in developing a more efficient system for handling their data. It’s the first step in creating an enterprise-wide intelligent automation process.
