5 reasons to use EDC for your clinical trial
Over the last decade the use of electronic data capture methods with comprehensive data collection and efficient management in clinical trials has become more prominent. According to Grand View Research, Inc., the global electronic data capture systems market size is expected to reach a value of almost €935 million by 2025.
At the same time, the volume of collected data during the trials continues to grow. Electronic data capture is used to help pharmaceutical companies and CROs achieve maximum efficiency when it comes to managing data, structuring a database and conducting analysis for clinical trials. Such digital tools can significantly reduce the time that would be spent if done with a traditional or paper-based method. On average it has been proven that EDC cuts 41% of pre-study preparation time, particularly time that would otherwise be spent on designing and producing paper CRFs.
So, let's just dive in and look through the complete list of advantages of EDC:
1. Data accuracy
- Real-time data and consistency checks;
- Legible entries;
- Automatic calculations;
- Better data management quality performance (less data entry errors).
EDC systems vastly improve data quality. Computerized system enables legible entries and automatic calculations contribute to cleaner data.
2. Efficient data management
- Data entries at sites;
- Real-time access;
- Unified database;
- Less time managing queries.
Digital templates are easily modified for each new study. Data is collected and entered into the system only once. In a paper-based method, data is typically first recorded on paper (CRF), and only then entered into the system by a data entry group, and saved in an eCRF. Although well-established, this method is not only time-consuming, but also error-prone.
3. Data security
- Data protected;
- Data backed-up;
- User and role-specific permissions.
Software vendors make sure data is protected and backed up. The system is hosted online. Each user account has designated permissions, and most actions can only be carried out by those holding certain roles.
4. Regulatory compliance
- Validated system;
- Data integrity;
- 21 CFR Part 11;
- Electronic source data verification.
An electronic data capture system must be compliant with regulatory requirements and standards. SOPs (standard operating procedures) are also required to ensure that regulatory and organizational requirements are met.
5. Patient safety
Using electronic solutions, investigators can improve patient safety. Today, with the rapid changes in clinical trial conduct that may occur due to the COVID-19 pandemic, including multiple deviations to address patient safety, EDC systems and ePRO are the best way for sponsors and investigators to capture data. Validated Data MATRIX solutions enable investigators to capture clinical trial data in a secure environment.
Nowadays, many research and biotech organizations realize the advantages of EDC over paper CRF and leverage on advanced technologies to support clinical trials. Most software vendors are constantly developing new functional enhancements and features to keep up with changes in the industry. For example, besides functionality that you’ll find in just about every EDC solution, Data MATRIX solutions include a Randomization Module, Electronic Patient-Reported Outcome (ePRO), and a Trial Supply Module for efficient planning of shipments and dispensing of drugs. Given the considerable reduction in the time from data collection to database lock, Data MATRIX solutions maintain a commitment to reducing research-associated costs.
