Electronic data capture systems revolutionised how we collect data in clinical trials increasing efficiencies and improving the quality of the data. However, two decades on, the marketplace is now saturated with EDC systems, all with vastly different functionalities and some more suited to specific therapeutic areas. Choosing a provider now becomes a tedious task for sponsors who may not be happy with their current supplier, but it’s often easier to stay with them than identify a better solution.
We have highlighted 5 key features of an EDC system which help streamline data collection in clinical trials and should be considered when choosing a new supplier.
One problem with many systems is a high learning curve due to the complexity of the system interface. With this in mind, a large amount of training and support is subsequently required to help the user understand and capture good quality data in a timely manner. An EDC system needs to be intuitive enabling the user to navigate naturally. A system with a low learning curve means that excessive training and support are unnecessary, saving time and costs, and removing any trepidation in using the system, causing delays to data being captured.
Access to your data is very important, it belongs to you. As part of this, relevant users of an EDC system should be able to view the data in real time, enabling active decision making during the trial rather than waiting for period summaries or reports. Data should be easily retrievable and exportable throughout the study lifecycle.
- Clear dashboard visualisation reporting and the ability to drill down into your data
As well as real time access, data should also be available in clear visualisations in a multitude of different methods. Scatter plots are a key visualisation where parameters can be compared and trends can be identified with the data. Traditionally this would not be available until TFL outputs are produced. Drill down from such visualisations to data listings and the eCRF data itself are important to better understand the trial – from a high level overview down to the intricacies of an individual dataset.
- Ability to capture multiple data types from different sources and devices
As we are now presented with an abundance of different technologies, we can harness these to capture data in a whole host of different ways. Through EDC, ePRO, medical devices, wearable technology and more. All integrated into one platform, feeding the data into a central repository. More “real time” data options are available, enabling subjects to capture data more frequently, enriching the data on a study, and minimising inconvenience to the subjects. EDC Systems must be able to capture and display such data in a meaningful way for the investigative and analysis teams.
- Integrated validation within the eCRF
More streamlined solutions are now in place to speed up and automate the cleaning and verification of data. Field level validation and verification at the point of entry ensures fast capture of good quality data and reduces the workload in source verification, query management and data management processing. Something as simple as using visibility switching to display only the fields the user must complete based on prior entries greatly simplifies the data capture process and provides clarity on data requirements.
Our system, SQN Health EDC, was designed around the needs and feedback of our clients and system users. We have translated these into an intuitive system with simple yet sophisticated electronic case report forms (eCRFs). We found that the features above have enabled us to meet the needs of the more complex study designs that are common now. They have proven to be important factors in the clinical trials we support for our clients. Our SQN Health ecosystem includes a number of technologies to help facilitate data capture within a trial, from EDC to ePRO and data visualisations.
To find out more, fill out our contact form and we will be in touch to discuss how we can support and enhance your clinical trial experience.