An electronic data capture (EDC) system is at the forefront of the technology evolution in clinical trials. Undoubtedly, the research paradigm is shifting towards greater decentralization, further globalization, increasing data endpoints, and more complex protocols.
With immense pressure to maximize efficiencies, research teams are searching for the right solutions to support their work. The right EDC system can set researchers up for success in building faster, robust trials.
Here’s what you can expect from this article:
- What is an electronic data capture system?
- What should an EDC support?
- What are the benefits of an EDC system?
- Frequently Asked Questions about EDC
- What to Look for in an Electronic Data Capture System?
If you want to learn more about what to look for in an EDC and its vendor, explore our buyer’s guide “Finding the Right EDC Solution for Your Next Clinical Trial”.
What is an Electronic Data Capture System?
An Electronic Data Capture system or EDC was originally created to digitize paper-based case report forms (CRFs).
Today, EDCs are no longer merely data entry systems for sites. Their function is transforming to accommodate the growing complexity and speed of clinical research. Rather than a single point of data entry, electronic data capture systems can now absorb a huge range of data sources coming from many places at different times.
In fact, EDCs are evolving into true clinical data management systems (CDMS) with the ability to support the end-to-end management of clinical trial data, including:
- data collection
- data cleaning
- data analysis
While electronic data capture is a component of a CDMS, the CDMS itself may include additional modules and features beyond data capture.
What Should an EDC Support?
Every study is different, so the right mix of purpose-built technologies can look different for each one. There are some basics, however, that every study needs for its success.
Your EDC solution should support the following:
- Secure, real-time access to clinical and patient-reported data
- Efficient data capture options with participant- and event-based workflows
- Simple mid-study updates and protocol amendments
- Consolidated monitoring with customizable ad hoc reports and visualizations
- Seamless integration of third-party data sources
The right electronic data capture system should provide features that help sponsors, CROs, and research sites achieve speed, ensure data quality, maintain control, and create seamless workflows.
What Are the Benefits of an EDC System?
Not all electronic data capture systems are the same. But EDC systems with an intuitive design and flexible functionality can provide benefits that ultimately help sponsors and CROs run more efficient, higher-quality clinical trials.
A few of the benefits you could expect from an intuitive EDC are:
- Speed up study build timelines
- Improve data quality
- Maximize operational efficiency
Speed up study build timelines
Overly complicated database builds can slow a study down before it’s even begun. On average, companies report needing 68.3 days to build and release a study database.1
To achieve greater speed, an EDC with an intuitive design and flexible functionality makes your study build and start-up process easy. To move forward faster, leverage EDCs that allow you to skip programming and unleash the power of automation and built-in logic.
Improve data quality
As we all know, the importance of quality clinical trial data cannot be overstated — maintaining data quality and control is key to ultimately getting regulatory approval.
An EDC that allows you to test and manage mid-study changes without risk offers real-time access to your data and includes built-in data standardization can help you to improve the overall quality of the data you are collecting.
Maximize operational efficiency
As clinical trials decentralize, the ability to collect electronic data from various sources is important for operational efficiency and an EDC plays a primary role in this collection.
Tufts Center for the Study of Drug Development reports that applying decentralized clinical trial (DCT) methods in Phase II and III studies can reduce a phase’s duration by three months.2 In the same report, they mention an increase in value of $8.6 million, on average, per investigational drug—nearly a five-fold return on investment (ROI).
An electronic data capture system that integrates with other solutions is critical to support clinical trial workflows—traditional, hybrid or decentralized—and maximize operational efficiency.
Frequently Asked Questions about EDC
- What is an electronic data capture system?
- An electronic data capture (EDC) system is a digital system that’s purpose is for the collection of electronic data during a clinical trial.
- What is the difference between EHR and EDC?
- EHR stands for electronic health record and is a digitized version of patient medical records. EDC stands for electronic data capture and is digital data captured during a clinical trial.
- What is an example of EDC data?
- A few examples of EDC data could be patient demographic information, bloodwork, symptom information, or any details about the treatment or condition being studied.
- Who uses EDC systems?
- Sponsors, contract research organizations (CROs), and research sites use EDC systems while running and managing a clinical trial.
What to Look for in an Electronic Data Capture System
The clinical trial landscape is evolving. A 2021 analysis by the Tufts Center for the Study of Drug Development (CSDD) found that phase III clinical trials now generate 3.6 million data points on average—approximately three times more data points compared to a decade ago.3
At the same time, more trials are embracing accelerated programs and blending multiple phases. This means future studies will include more sites, participants, data, arms, and mid-study changes.
With all these changes, it is important to choose the right digital tools to support clinical trials.
- Tufts CSDD Impact Report Volume 20, Number 1 January and February 2018 & Tufts CSDD Impact Report Volume 23, Number 2 March / April 2021
- Tufts CSDD Impact Report Volume 24, Number 5
- Tufts CSDD Impact Report Volume 23, Number 1 | Jan/Feb 2021 (2021). Tufts CSDD Impact Report, 23(1). https://doi.org/Jan/Feb