The demands of clinical trials have never been higher – faster timelines, stricter compliance, and greater volumes of data. Meeting these expectations requires smarter, more streamlined ways to manage trial information from start to finish.
That's where electronic data capture (EDC) systems come in. These tools form the foundation of modern trials, enabling cleaner datasets, faster access, and smarter decisions from day one.
What is EDC?
Electronic data capture (EDC) is software used in clinical trials to collect, manage, and store patient data electronically. It replaces traditional paper-based methods with a structured digital workflow that allows researchers to capture information more accurately and efficiently. EDC systems are widely used to improve data quality, reduce manual errors, and support real-time access to clinical trial data across teams and sites.
Types of EDC systems
Understanding the types of EDC software is essential when choosing the right system for your trial. Deployment models vary based on your infrastructure, regulatory needs, and scalability requirements.
Cloud-based EDC systems
Cloud-hosted systems are managed by a vendor and accessed via the internet. They're widely used because they’re fast, flexible, can be updated in real time, and don't have heavy IT overheads.
Benefits:
- Rapid deployment and upgrades
- Easily scalable across global study sites
- Minimal internal maintenance required
Drawbacks:
- Less control over data storage policies
- Dependence on vendor infrastructure and uptime
Web-based EDC systems
Like cloud-based EDC, web-based platforms are accessed through browsers, but may be hosted on private servers. This hybrid model provides a good balance of accessibility and control.
Benefits:
- Accessible from multiple devices and locations
- Customizable for site-specific or sponsor-specific needs
Drawbacks:
- May require dedicated IT resources
- Updates aren’t always automatic
On-premises EDC systems
These are hosted within an organization’s own infrastructure. They provide maximum control and security but require more internal support and have higher costs.
Benefits:
- Full control over system architecture and data storage
- Can be tailored for highly regulated or proprietary environments
Drawbacks:
- Expensive to set up and maintain
- Slower to scale across multiple study sites
Electronic data capture examples in clinical trials
There are many electronic data capture systems to choose from so exact functionality varies, but it’s important to clear up a common misconception. EDC isn’t an umbrella term for different clinical tools. It describes a system designed to capture, manage, and store data only. EDC systems aren’t all-in-one solutions. Tools like electronic case report forms (eCRFs), electronic patient-reported outcomes (ePROs), and wearable tools are often confused as being part of an EDC system, when in reality, they’re integrations or add-ons.
These tools form part of a broader eClinical suite – each working in harmony with the EDC to support specific aspects of trial design, data capture, and patient engagement.
So, what are some accurate electronic data capture examples?
These are specific types of clinical trial data that an EDC system collects and manages, such as:
- Demographic data
- Treatment details
- Medical history
- Efficacy data
- Safety data
Now let’s look at some key EDC integrations – tools that connect to or enhance the EDC system – and how they function in real trials.
Electronic case report forms (eCRFs)
eCRFs are digital forms used by clinical sites to enter data based on the trial protocol. These forms capture information from the site, such as clinical observations, lab results, visit logs, and adverse events. They feature built-in logic and real-time edit checks that validate entries at the point of capture – flagging out-of-range values, missing fields, or timeline inconsistencies. This immediate feedback reduces downstream data queries.
For instance, in an oncology trial, eCRFs might be used to capture critical data such as lab values, imaging results, and physician notes at each patient visit – allowing consistent, data collection over time. Or, a dermatology study could use custom eCRFs to monitor lesion size and track treatment adjustments, enabling accurate response evaluations across patient visits.
Electronic patient-reported outcomes (ePROs) and electronic diaries (eDiaries)
ePROs and eDiaries allow participants to submit self-reported data – such as symptoms, treatment side effects, and quality-of-life measures – using smartphones, tablets, or web portals. These tools reduce recall bias by enabling real-time data entry and give researchers a more continuous, nuanced view of treatment impact.
For example, in a chronic pain trial patients might use a mobile app to log daily pain scores and sleep quality, giving researchers valuable insights into treatment efficacy. In a respiratory study, ePROs could collect data on breathlessness during everyday activities, capturing patient experiences that wouldn’t be easy to record during site visits.
Device and wearable integration
Integrating EDC systems with wearables and connected medical devices allows researchers to collect continuous data like heart rate, glucose levels, or physical activity. These integrations are typically achieved through APIs or middleware and are particularly useful in decentralized or long-term trials.
For example, a cardiovascular study might integrate ECG patches to monitor arrhythmias remotely between site visits. This would reduce reliance on in-person assessments. Or, a diabetes trial might use continuous glucose monitors (CGMs) connected to the EDC system to track blood sugar levels in real time – helping identify trends and optimize treatment regimens.
Real-world examples from Viedoc
Accelerating patient screening with ePRO integration
LINK and AlzeCure streamlined participant screening by using Viedoc’s ePRO software to collect patient-reported data during the early stages of enrolment. The system enabled real-time data capture directly from participants, improving data quality while reducing site burden. They shortened screening timelines by shifting from paper forms to a digital, patient-facing tool and improved protocol adherence.
Enhancing medical device trial management with EDC
When managing complex medical device trials, Qmed implemented Viedoc’s EDC clinical trial software, so they could scale efficiently, simplify data collection, and maintain data integrity. The system supported rapid study builds and regulatory alignment, helping Qmed adapt to protocol changes and device-specific requirements.
Supporting global device trials with EDC and eCRFs
MDCES manage multiple medical device studies across international sites using Viedoc’s EDC software with integrated electronic case report form software. The solution enabled consistent, compliant data collection across locations, while the user-friendly interface made it easy for global teams to capture and validate data in real time. With the EDC and eCRFs working in tandem, MDCES improved operational efficiency, streamlined workflows, and maintained regulatory compliance across borders.
Making sense of electronic data capture
Electronic data capture software streamlines the entire clinical data lifecycle, from the first patient visit to regulatory submission. True electronic data capture examples refer to the core data collected during trials, while tools like eCRFs, ePROs, and device integrations expand the reach and value of the EDC system.
If you're evaluating EDC options, we can help you navigate the selection process and build a system tailored to your trial’s needs.
