The Benefits of Digital EDC Systems in Clinical Studies
Research by Sahoo & Bhatt (2004) has demonstrated several clear advantages of an EDC system over traditional paper-based methods in clinical research:
1. Increased Data Reliability
EDC systems minimize human errors through real-time and automatic data validation. For instance, if you accidentally enter an implausible age like 150 years, the system will flag this and prompt you to correct it. EDC systems ensure that everyone follows the same rules for data entry, making the data consistent, accurate, and reliable. This reduces the need for manual data checking and cleaning, as it automatically excludes patients with incorrect or incomplete data from the analysis.
2. Improved Efficiency Leads to Faster Results
By collecting data digitally in a centralized location, many processes in the clinical study are accelerated. Researchers can gather, analyze, and report data more quickly, saving significant time and effort. This efficiency arises from reduced work with form retrieval, correction requests, and resolving data analyst queries.
3. Cost Savings Between 49 and 62%
The increased efficiency in processes speeds up the duration of clinical studies by weeks or even months. This reduces the total costs of the study. Therefore, using an EDC system is an investment that results in both time savings and cost reductions (Chakraborty et al., 2022).
4. Compliance with Regulations
An EDC system helps meet stringent regulatory requirements and simplifies external audits. The system includes detailed logs that record all data interactions. Every time data is entered, modified, or deleted, it is logged. This meticulous tracking allows auditors to more easily and quickly access the necessary information to verify that the clinical study was conducted correctly. Managing everything on paper can quickly become overwhelming and time-consuming during an audit.
5. Remote Access and Better Collaboration
With cloud-based EDC systems, researchers and clinical staff can view real-time status and access data remotely. This enhances collaboration and significantly simplifies the process of collecting patient data from multiple locations.