Electronic data capture (EDC) systems have become essential technology for clinical trials because they help streamline workflow, increase collaboration, and reduce the costs and resources associated with collecting, storing, and distributing clinical trial data. Although all EDCs deliver some combination of those benefits, selecting the one that best fits an organization’s computing infrastructure, trial types, reporting requirements and more can ensure the organization gets the most out of this essential technology.
This paper is intended to help clinical-trial sponsors, CROs and sites navigate the process of EDC vendor selection and make a better-informed purchase decision on this key technology for clinical research.
High-level EDC benefits
EDC is the essential system in the larger family of eClinical technology, and the repository for data that will be passed to regulatory bodies for scrutiny. EDC modernizes data collection in clinical trials, whether that data is first recorded on paper and manually entered into the system, or captured directly through a computer. When compared to studies in which data is transcribed from paper into an Excel spreadsheet, EDC offers several benefits, including:
- Regulatory compliance
- Data quality
- Data integrity
- Patient safety
These benefits yield cost savings through reduced need for resources, shorter study timelines, or a more nimble study structure that can adjust to changes more quickly. EDC brings the benefits of data aggregation, self-service, and workflow flexibility to clinical trials.
Two fundamentally different types of EDC
A basic, fundamental choice EDC buyers must make is between on-premise software and cloud-based software.
- On-premise software—An on-premise system lives at the CRO or sponsor location, and is maintained by an IT team and supported by one or more programmers. The hardware can range in size and complexity from a single laptop to a rack of servers running custom-built software. It’s usually built from a standard base package, and customized with the addition of modular code and user-specified functionality.
- Cloud-based software—A cloud-based system lives on the internet. While it’s still dependent on a central server, that server can be located anywhere in the world, and the system is accessible from anywhere with internet access. Cloud-based software tends to come standard with more functionality and more frequent updates, and is typically more affordable, since the same software code base is being used by thousands of customers. Cloud computing frees sponsors and CROs to do what they do best—focus on gathering and analyzing data—rather than building and maintaining an on-premise IT infrastructure that requires data centers, real estate to house them, and skilled professionals to operate them.
Deciding between EDC types
Study complexity, number of sites, and budget typically are among the factors that influence an organization’s EDC buying decision. Key differences between the on-premise and cloud options also include:
- Time and cost—On-premise solutions tend to cost more over time, as they’re custom-built to a specific protocol and need a team to install and maintain. As a result, they tend to take longer to implement and set up due to the time needed to complete installations on servers and each individual computer or laptop. They also make mid-study changes harder. But the benefits of having a system tailored to the study protocol can pay dividends on complex studies with unusual data requirements. Cloud-based EDC systems are more affordable because the functionality is off-the-shelf. They cater to the 95% of studies that have straightforward data requirements.
- Data accessibility—Cloud systems excel at enabling collaboration in real time. A recent study found that 76% of CROs and 67% of sponsors are looking for tools to help with collaboration and data transparency, respectively. Cloud-based EDC gives sponsors and CROs visibility into recruitment and data collection goals directly from their sites as well as a way to socialize real-time data between stakeholders.
- Monitoring—Another benefit of cloud-based EDCs is efficient monitoring. If data is collected electronically through an eSource tablet, monitors are able to check source data through the cloud, instead of shipping paper or having the monitor travel to each site. Organizations have reported a 50% reduction in site visits, which results in significant cost savings.
Industry experts believe that cloud solutions are the future. In fact, many on-premise providers are moving to the cloud and its fast, convenient, and safe solution for the collection, storage, and distribution of clinical data at a lower total cost of ownership.
Simplifying study build
The ability to simplify study build is another feature to look for when comparing EDCs. The latest generation of EDCs offer simple setup and an intuitive, drag-and-drop interface that enables organizations to build studies rapidly, without requiring any expertise outside of clinical research. Using these EDCs, someone with a layperson’s experience in computer technology can build studies easily, quickly and on their terms. There’s no need to engage professional programmers or outside vendors and pay additional fees.
In addition to simple study build with no programming, such EDC systems give users full control by offering the ability to make mid-study changes quickly and independently, without taking a study offline or relying on technical support.
Understanding which features matter most
Organizations choosing an EDC should assess how a vendor implements the following features in order to optimize protocol implementation, data entry, and more.
eClinical software users need a solution that offers speed and accommodates sites in various geographies. When it comes to building and deploying electronic case report forms (eCRFs), here’s what that means:
- Ownership and control—As explained above, cutting-edge EDC tools reduce costs and timelines by allowing users to build their own eCRFs with a simple drag-and-drop interface, without relying on IT or programming staff. Users can also make their own mid-study changes.
- Localization and standardization—Cloud-based solutions allow users to deploy new eCRFs by geography and site, helping localize work for language, measurement systems, and more.
Once eCRFs are built, an EDC solution should offer modern features—impossible with paper CRFs or early EDC solutions—that create smarter processes for managing and collecting data. These features accelerate data entry, monitoring, and more, all while maintaining quality.
- Data quality—Soft and hard range checks ensure errors are caught at the point of data collection, where the data can be verified. Reminders ensure measures are taken consistently. And skip logic creates efficiencies by eliminating irrelevant fields.
- Monitoring—The ability to monitor data remotely, with no paper and in real time, will enhance detection of safety issues and adverse events as well as significantly reduce travel and transportation costs.
- Reporting—Robust reporting functionality facilitates the collaboration necessary to proactively make necessary study changes. Users can identify low-performing sites and other issues, and take the necessary steps to get everything running smoothly again.
Features related to regulations
In the evolving regulatory environment of today’s clinical trials, an ideal EDC goes beyond simple CFR Part 11 compliance. Crucial regulatory offerings that buyers should look for include:
- Reduced validation burden—When changes to studies occur solely in the EDC database, with no effect on the code base, it eliminates the need for repeated database validation after each change. The ideal EDC offers this efficiency.
- A finger on the pulse—Today’s best EDC solutions stay on top of current events and recent regulatory changes, such as the upcoming European privacy regulations, the effect of the rise of mHealth tools on FDA regulations, and more. Leading EDCs have the ability to seamlessly adopt these frameworks into the software.
Additional modules for faster data collection, increased patient engagement
eSource brings eClinical technology to the site level, empowering users to capture source data electronically and sync it to EDC with no paper involved. An EDC solution that provides access to eSource, either through native offerings or through integration, can:
- Accelerate data collection
- Ensure accuracy by reducing transcription errors and alerting personnel to missing or out-of-range data
- Share data immediately, reducing the need for monitoring visits
These benefits have a huge impact on trial costs and timelines, allowing organizations to increase the number of studies without scaling up headcount. Even in WiFi dead spots or during internet downtime, the more cutting-edge eSource solutions are still functional. These tools allow users to store data locally and sync data to an EDC when connectivity is restored. Depending on workflow and study needs, users can sync after every subject, before and after each shift, or anywhere in between.
ePRO allows trial subjects to submit information like quality of life data from the comfort of their home or on vacation. This allows organizations to:
- Reduce the number of scheduled visits and burden on subjects’ busy lives
- Improve patient retention rates
- Keep recruitment costs under control
As the clinical research industry places more and more value on patient centricity, eClinical solutions offering ePRO help users stay ahead of the curve.
Maximizing EDC benefits for each organization
There are many EDC vendors, and their solutions offer a range of options, features and functionality. Because there is no one-size-fits-all solution, decision-makers at clinical-research sponsors, CROs and research sites need to assess their needs and evaluate the range of EDCs available to find the one that will best enable them to streamline their workflow, increase collaboration, and reduce costs for collecting, storing and distributing clinical trial data.
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