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:
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.
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:
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:
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.
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:
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:
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:
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.