EDC 101: What is Electronic Data Capture in Clinical Trials?

Clinical trials have long been burdened by huge amounts of data combined with a massive need for meticulous accuracy. Traditional paper-based methods of capturing and recording clinical trial data are time-consuming and prone to errors—all while the scale and complexity of clinical trials have only continued to increase. 

For sponsors and CROs, that has meant there are more opportunities for mistakes and fewer opportunities for optimization. 

That’s where electronic data capture (EDC) systems have played a major role in revolutionizing the landscape of clinical trials.

Here’s a closer look at how much an EDC can optimize the clinical trial process, reduce human errors, and streamline the path to trial success across the industry.

What’s an EDC and How Do They Impact Clinical Trials?

EDC systems facilitate the collection, storage, and management of data generated during clinical trials. Their main function is creating electronic case report forms (eCRFs), which are filled out at each clinical trial site.

These systems feature user-friendly interfaces, making it easy for clinical staff with varying technical expertise to find and enter data. This helps speed the data entry into eCRFs to reduce roadblocks and support more efficient clinical trials. 

Over the years, EDCs have also evolved their data collection capabilities. Other electronic data sources and processes have been integrated with EDC, such as electronic patient reported outcomes (ePRO), interactive response technology/randomization and trial supply management (IRT/RTSM), imaging; and more recently sensors and electronic health records (EHR), expanding the scope of EDC beyond traditional site data entry into eCRFs. 

As a result, many EDCs now have the capabilities of complex platforms, offering real-time data capture, validation, and reporting capabilities. 

The utility and efficiency of EDCs have made them instrumental in supporting the development and optimization of clinical trials.

Typically, the computer systems used for EDC data entry at clinical sites may not be readily available for direct use at the patient’s bedside or in the clinician’s room during a patient visit. Instead, it's common for clinical sites to rely on traditional paper charts and forms for recording patient data, with subsequent transcription of this information into the EDC system.

A notable shift is observed with the growing adoption of eSource, where data is collected electronically at the source—be it at the bedside or during patient visits. EDC systems are adapting to support this trend by offering capabilities for bedside data entry at the site or even facilitating data collection in non-clinical settings (such as a patient's home) through devices like tablets.

This evolving landscape underscores the dynamic nature of data capture methods within clinical trials.

Who Uses an EDC?

Once clinical research coordinators (CRCs) at the sites have entered data into an EDC system, it’s immediately available to contract research organizations (CROs) and sponsors. Clinical research associates (CRAs) can perform monitoring activities, and clinical data managers can review and clean the data, communicating with sites via a query management capability. Once data is finalized, the principal investigator (PI) at the site provides an electronic signature. CRAs and data managers can then mark data as verified and reviewed, and the data can be locked to prevent further changes and allow analysis of the trial data to start.

What are the Benefits of EDC Systems for Clinical Trials?

The advent of EDC systems marked a significant shift, introducing a more streamlined, efficient approach to clinical data management. 

These systems offer unparalleled advantages in terms of data quality, compliance with regulatory standards, and overall trial efficiency.

Some of the most powerful benefits of an EDC system for a clinical trial include:

• Enhanced data accuracy: EDC systems reduce human error in data entry, helping to minimize otherwise avoidable errors in datasets.
• Improved trial efficiency: EDC systems simplify data management tasks, allowing for less time spent on manual processes and enabling faster decision making.
• Real-time data access: Using an EDC, clinical trial teams can access and analyze data instantly.
• Improved cost-effectiveness: EDCs offer significant financial advantages over traditional methods by reducing resource utilization and speeding decision-making.

How Do I Choose the Right EDC System?

Choosing the right electronic data capture system for your clinical trial is a critical decision that can impact the efficiency, accuracy, and success of your research.

Because the data from the EDC is ultimately the data that gets submitted to the FDA for drug approval, features like accuracy and reliability are crucial determining factors when selecting the right EDC. 

By carefully considering these factors, you can make an informed decision when choosing an EDC system that aligns with the specific requirements and goals of your clinical trial:

• User-friendliness: An intuitive, easy-to-use interface is critical to the long-term success of your EDC system. In particular, consider the ease of use for the clinical research coordinator and principal investigator at clinical trial sites. An intuitive interface can minimize training time and reduce the likelihood of errors during data collection.
• Scalability: As the size and complexity of your clinical trials change and evolve, your EDC needs to be able to scale to meet new needs and challenges. Ensure that the EDC system can accommodate changes in the size or scope of your study. Scalability is important for both small early-phase studies and large multicenter trials.
• Customization options: The right EDC should offer your team the flexibility to adapt to the unique demands of clinical trials, regulatory changes, and technological advancements. A flexible system provides researchers with the agility to respond to evolving study requirements and industry trends, contributing to the overall success and efficiency of the clinical trial process.

How Do Medidata EDC Systems Help Optimize Clinical Trials?

Medidata's Rave electronic data capture system optimizes clinical trials by providing a comprehensive platform that enhances efficiency, data quality, and collaboration among stakeholders. 

Medidata is the pioneer in electronic data capture—trusted by sponsors and CROs to run 36,000+ clinical trials and capture data from millions of patients.

Rave EDC has the flexibility and scalability to run all your biopharmaceutical or medical device studies—regardless of size, phase, or therapeutic area. 

Our EDC system also offers unparalleled reliability and uptime. The combination of our technology and experienced Professional Services team ensures smooth implementation of mid-study changes with no downtime—for even the most complex, time-sensitive trials. 

Plus, our data security, privacy, and quality processes, systems, and certifications are second-to-none in the life sciences industry. This ensures the security of your clinical trial data and the privacy of your patients.

“The best qualities of Rave EDC are how user-friendly [it is] for the sites to enter data…, how the query management is very efficient, and [the ease of] getting the data out.”

– Vijay Chundru, Senior Director, EDC Programming Team, Global Clinical Data Operations, Jazz Pharmaceuticals

What Future Trends Will Impact EDC Technology?

EDC technology is dynamic and continually evolving; it’s driven by technological advancements, changes in regulatory requirements, and the increasing complexity of clinical trials.

Several future trends are anticipated in EDC technology, reflecting a shift toward more advanced, efficient, and patient-centric approaches.

Emerging Technologies in EDC

New technologies are continuously influencing the landscape of electronic data capture systems, offering innovative solutions to enhance the efficiency, accuracy, and flexibility of clinical trials.

• Integration with AI and machine learning: AI algorithms can help automate medical coding of EDC data and assist clinical data managers with data reconciliation. They may also help identify patterns, outliers, and potential data discrepancies, improving the overall quality of collected data. Machine learning enables more sophisticated risk prediction models, helping prioritize monitoring efforts based on the likelihood of issues.
• Mobile and remote data capture: Mobile data capture allows clinical trial participants, investigators, and site staff to enter and access data from anywhere, reducing the need for physical paperwork and increasing efficiency. This is especially relevant given the growing adoption of eSource, which facilitates easier data entry from a bedside or even non-clinical location from a tablet device.

Predictions for Future Advancements in EDC Technology

As technology continues to advance and the clinical research landscape evolves, future advancements in EDC technology will create more efficient, patient-centric, and data-driven approaches to conducting clinical trials.

• Enhanced interoperability: Enhanced interoperability will facilitate seamless data exchange and collaboration among different healthcare and research platforms. By adopting standardized practices, embracing interoperability frameworks, and fostering collaboration within the clinical research community, EDC systems can become more seamlessly integrated with other components of the research ecosystem
• User-centric design innovations: To make sure that future EDC platforms are intuitive, efficient, and meet users' needs in the clinical research environment, features like multi-device accessibility and interactive data visualizations will become critical.

Impact of EDC Advancement on Future Clinical Trials

The advancement of electronic data capture systems is projected to significantly transform future clinical trials by enhancing efficiency, accuracy, and cost-effectiveness.

Specifically, EDC systems’ capabilities for site data entry, including direct data entry on tablets, and automating completion of electronic case report forms (eCRFs) with existing electronic health record (EHR) data, will streamline data collection and minimize errors associated with manual data entry.

This technological upgrade will save time and resources and facilitate real-time data access, fostering quick and informed decision-making.

In addition, migrating data validation, monitoring, and review capabilities to the clinical research platform will enable their application across all clinical trial data sources, such as lab data, electronic clinical outcome assessments (eCOA), sensors, imaging, and more.

This integrated approach will provide a comprehensive view of the trial, leading to higher-quality data, improved patient safety, and, ultimately, more reliable trial outcomes.

Understanding Regulatory Compliance and Data Security with Clinical Trial EDCs

Regulatory compliance and data security are critical aspects of utilizing electronic data capture systems in clinical trials. 

EDC systems are designed to comply with good clinical practice (GCP), a set of international ethical and scientific quality standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. 

EDC systems must also adhere to the regulations outlined in FDA 21 CFR Part 11, which governs electronic records and electronic signatures. This includes features such as electronic signatures, audit trails, and data security measures. 

Detailed audit trails within an EDC also help capture and record all activities related to the creation, modification, or deletion of electronic records. These audit trails support transparency and accountability during regulatory inspections. 

There are also several critical data security features an EDC must offer, including:

• Encryption and access controls: Encryption mechanisms to protect data during transmission and storage. Robust access controls to ensure that only authorized personnel have access to specific functionalities and data within the EDC system.
• Data privacy and security: Data governance and integrated safeguards should provide the oversight and accountability needed to protect data. The EDC should also be highly stable and protected from cyberattacks.

EDC Success Stories from Real Medidata Customers

See how our clients describe their real-world success stories using our Rave EDC system to implement major efficiencies in their clinical trial process.

• • “The best qualities of Rave EDC are how user-friendly [it is] for the sites to enter data…, how the query management is very efficient, and [the ease of] getting the data out.” – Vijay Chundru, Senior Director, EDC Programming Team, Global Clinical Data Operations, Jazz Pharmaceuticals

  • “This is where working with a partner like Medidata, that builds solutions such as Rave EDC and others, … helps us really leverage the extended expertise over years that they’ve built, to have reassurance and work on a robust platform.” – Hassan Kadhim, Global Head of Clinical Trial Business Capabilities, BMS

  • “We had a study with 6,000 patients on it. [With Rave EDC] You could change 6,000 patients in hours, whereas another platform took four months to adapt their CRF [case report form] because the platform just wasn’t capable. I know when you say to people, ‘How long is that going to take to update the CRF?’……. ‘Once it’s all signed off, it’ll be an hour maximum,” Other platforms……definitely do take a lot longer.” – Ian Howson, Senior Manager, Database Programming, Parexel

Learn How an EDC Can Help You Adapt to The Future of Clinical Trials

As the landscape of clinical trials continues to evolve and change, it’s critical that sponsors and CROs employ advanced, flexible, and reliable EDC systems to streamline and secure data collection, improve the patient experience, and streamline their internal processes.

Adopting and leveraging EDC systems empowers researchers to adapt to the future of clinical trials by enhancing efficiency, data quality, patient engagement, and overall trial management.

The continuous evolution of EDC technology aligns with the dynamic nature of clinical research, contributing to more effective, patient-centric, and data-driven approaches to drug development and medical research. 

Learn more about Rave EDC, part of our Medidata Platform, and see how we can help optimize your clinical trial process.