The most powerful benefits of Electronic Data Capture system usage in clinical trials
Electronic data capture (EDC) system - is the system for data collection and management in clinical trials. It is used as a convenient and beneficial alternative to the paper CRF. More than 75 percent of clinical trials are held with the EDC system. Indeed, clinical trial electronic data capture system has a bunch of advantages. We are going to list the most significant advantages for the clinical trial.
The duration of clinical study
You can save your time by using EDC system. At the end of the data collection stage, all refinements and preparation for statistical processing take minimum time. While paper-based trial initiation is fast, the main delay comes up during refinement, cleaning and database structure forming processes.
Lowering the clinical trial cost
One of the main cost items in clinical trials is on-site monitoring cost. The more countries and sites are involved in the trial, the more CRAs are needed to monitor the process. Each CRA requires payment per hour. And don’t forget about the travel expenses. As the result - total amount of a project cost comes out to be really high.
Electronic trial data capture system automates most of the clinical trial procedures in order to make them more facilitate. As the result, the total cost of clinical trial comes up to be lower, than without using the EDC system.
Concerning EDC, the main part of the monitoring process can be held remotely. CRA watches through all completed CRFs in the system, and in case if problems occur - reports to the investigator. Additionally, remote monitoring takes a couple of hours and doesn’t assume any business trips.
Also, we have to take into consideration, that each month of drug development prolongation causes tens of thousand USD lost profit. Thus, a qualified data management makes market authorization faster and speed up the return on investment.
Clinical trial process clarity
Via electronic trial data collection system, it is possible to audit the clinical study process online, using the computer only. Thereby it is easy to determine bottlenecks on different stages of clinical data gathering.
Quality of the collected data
Each modern EDC has a variety of tools to ensure data quality.
- Auto checks. They work online when data is entered. These checks cut off incorrect data, identify mistakes during the fields filling out. For example, the user can’t enter text into date area. The system instantly informs of invalid data so that the investigator have to check it.
- Medical coding. All symptoms and diseases names are coded according to international terminology. This helps to avoid inaccuracy and statistic processing issues.
- Remote monitoring. EDC system allows to set up special authority (access rights) for CRA, so he can observe data in every CRF and create queries in one click. So if the mistake was not identified automatically, it can be found and fixed manually.
- Numerical data validation. This function helps to detect and to fix uncertain data. For example, the system can check numeric values for height and weight. In the case when investigator entered 17sm instead of 170sm the program will report it.
Database safety, confidentiality and reliability
All data entered is stored on protected servers. As usual, servers are located in different countries. In case of troubles with one of the servers, it is not a problem to restore data from another one.
EDC system instantly copies entered data to the backup server. These copies are made incrementally after a certain period of time. Thereby, an information can be completely restored.
There are different levels of access rights. It means that only limited quantity of users can have access to view electronic CRF after the end of the trial. Every view and every change is logged. You can find information about who and when has made changes to eCRF.
OnlineCRF - an electronic trial data gathering system
We created our electronic clinical study data management system including modern requirements and normative documents. Thereby, we have successfully implemented all available advantages of EDC in one product - OnlineCRF.