Faster access to data. With effective EDC systems, real-time access to data is not a myth. In addition, EDC supports faster decision-making and enables tailor-made trial designs. There’s also faster access to data for analysis, with less time spent on query management. All these features and opportunities promote the study progression and further audits.
Data accuracy. With the implementation of EDC, it is much easier to enforce certain features of data quality and its readability. In fact, there are checks implemented in data entry, reducing the probability of errors. Various tools can clarify the discrepancies in the data for identifying, reporting, and resolving data issues. This, in addition, makes the process more efficient and reduces the number of in-person visits during a clinical trial.
Facilitates the progression of the trial. EDC systems guide the series of study events during a certain trial, thereby helping experts achieve the study objectives much faster. Most EDC systems have user-friendly navigation and search options, enabling a user filter to find the required information at a given time. That also limits the time needed for training personnel, which in addition cuts costs. Note that data can also be stored in one location with greater visibility for later analysis and quality control.
Compliance and Safety. EDC systems have numerous technical controls that ensure the integrity of data in line with the statutory legal regulatory requirements in research. EDC means safety. Data entry in an EDC system is done on a web-based interface, usually, with the system being hosted online. ConductScience Digital Health ensures that such data is always backed up and protected with restricted user accounts. These features guarantee the integrity of the data collected and its safety – simply because most actions are only permitted by authorized persons.
Features of Effective EDC Systems
Although EDC systems have many advantages over paper forms, some researchers still prefer conventional techniques as they feel insecure about changes, implementation, and costs. Therefore, to eliminate any confusion among experts and patients, EDC systems enable the following vital features:
- Data entry functionality that enables the entry of information into appropriate forms. Note, the study protocol must be set up in the system first.
- An eCRFs design tool that provides access to eCRFs. In fact, this feature guarantees the adoption of the specific standards involved in the study.
- A reporting tool to capture, manage and analyze the data collected. The transparency of data has always been the main objective.
- A graphical and easy-to-use interface. As mentioned above, this feature not only facilitates research but increases the levels of motivation and satisfaction.
- A validation component, such as out-of-range values and specific codes. Thus, errors are easy to spot and fix.
- Edit checks are also needed to limit the entry of invalid data. Missing answers and values are an obstacle to a good EDC system.
- Export of data and safe access. In other words, standards and regulations are followed, while at the same time, multi-centered research is enabled.
- Query management to support streamlined communication between data managers, monitors, and the coordinators of a clinical study. All with the purpose to help patients and medicine.
mEDC: Pick up your phone, answer research demands
During the years, EDC systems have continued to evolve leveraging the latest Internet-based technologies. The providers have come up with specialized software solutions that can target specific subject profiles or study phases. The rise of wireless EDC systems in clinical trials has also proven to be very useful, especially in countries with unreliable internet access. The development of mobile device-based electronic data capture (mEDC) that is used to capture electronic data by use of cellular phones has revolutionized clinical research.
The use of mobile devices, such as mobile phones and personal digital assistants (PDAs), in such places, has demonstrated great performance in conducting clinical studies. More effective training to the staff, high-quality data, cost-effectiveness, improved user-friendly design, real-time data exchange, and constant monitoring of the study are just some of the advantages of mEDC.
On top of that, with the implementation of apps, data could be collected remotely (via mobile devices) by experts worldwide. This feature is particularly handy in telemonitoring and project management. In fact, a study conducted by Zhang and colleagues (Zhang et al., 2017), which was validated across 14 hospitals and 1333 patients, showed the high levels of effectiveness of mEDC. Although mEDC systems are comparatively new, all parties involved in research show high levels of satisfaction. mEDC facilitates site equipment, patient recruitment, data collection, patient referral, remote validation of data, data storage, data management, quality control, and institutional review board operations.