What is an Electronic Data Capture (EDC) System in Clinical Trials?

8 min readJan 17, 2023

An Electronic Data Capture (EDC) system is a computerized system used to collect, store, and manage clinical trial data electronically. EDC systems are designed to streamline the data collection process, making it easier and faster for trial staff to enter and validate data. This can help to reduce errors and inconsistencies in the data, and improve the overall quality of the trial data.

EDC systems provide a number of benefits over traditional paper-based methods of data collection, including increased efficiency, accuracy, and security. They provide real-time data validation, which helps to ensure that the data collected is accurate and complete. They also enable real-time monitoring of data quality, which means that trial staff can quickly identify and resolve any issues with the data as they arise, rather than waiting until the end of the trial to discover and correct errors.

EDC systems also provide a secure and centralized repository for storing trial data. This helps to ensure the confidentiality and privacy of patient data, and enables trial staff to access and manage the data from any location. They are also used to support other aspects of the trial, such as trial monitoring and site management.

EDC systems are an essential part of the clinical trial process, as they help to ensure that the data collected is accurate, complete, and consistent. This is critical for the analysis and reporting of trial results, and for making decisions about the safety and efficacy of a new drug or treatment.

EDC systems also play a key role in compliance with regulatory requirements. The data collected in a clinical trial must be accurate, complete, and consistent in order to support the safety and efficacy claims of a new drug or treatment. EDC systems must comply with guidelines and regulations set forth by agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

EDC systems can be used for a variety of different types of clinical trials, including trials for drugs, medical devices, and biologics. They can also be used for observational and epidemiological studies, as well as for patient registries.

In addition to the traditional on-site clinical trials, EDC systems can also be used for remote trials, such as virtual trials, decentralized trials, and e-trials. EDC systems must adapt to the specific challenges that these trials present, such as monitoring remote data collection and ensuring data security in a virtual environment.

In summary, EDC systems are an essential part of the clinical trial process that help to ensure the accuracy, completeness, and integrity of the trial data. They play a critical role in trial management, quality assurance and regulatory compliance, and can be used for a variety of different types of clinical trials, including traditional on-site clinical trials and remote trials.

Types EDC systems used for clinical trials

There are different types of Electronic Data Capture (EDC) systems that can be used for clinical trials, depending on the specific needs of the trial. Some common types of EDC systems include:

Web-based EDC systems: These systems are accessed through a web browser, and can be used by trial staff from any location with internet access. This type of EDC system is well suited for multi-center trials or trials that involve remote data collection.
Cloud-based EDC systems: These systems are hosted on a cloud computing platform, which allows for easy scalability and accessibility. This type of EDC system is well-suited for trials that involve large amounts of data or require real-time data access.
Standalone EDC systems: These systems are installed on a local server, and can only be accessed by trial staff within the same organization. This type of EDC system is well-suited for smaller trials or trials that do not involve remote data collection.
Hybrid EDC systems: These systems combine elements of web-based, cloud-based and standalone EDC systems, and provide a flexible solution that can adapt to the specific needs of the trial.
Custom EDC systems: These systems are tailored to the specific needs of the trial, and can include custom data validation rules, reporting, and analysis tools.
Integrated EDC systems: These systems are integrated with other software such as eClinical systems, electronic health records (EHRs) or laboratory information management systems (LIMS) to provide a more comprehensive view of the patient’s health and allow the data to flow seamlessly between different systems.

It’s important to note that the choice of EDC system will depend on the specific needs of the trial, including the size and complexity of the trial, the data collection requirements, and the budget for the trial.

Another important consideration when choosing an EDC system is the level of user-friendliness and ease of use. EDC systems that are designed with a user-friendly interface can help to reduce the training time required for trial staff, and make it easier for them to use the system effectively.

It’s also important to consider the level of technical support and maintenance provided by the EDC system vendor. A reliable EDC system with good technical support is essential to ensure the smooth running of the trial and to minimize any disruption caused by system failures or downtime.

Security is also an important consideration when choosing an EDC system. EDC systems must comply with regulatory requirements for data security, and should include features such as data encryption and secure data storage to protect patient data.

Finally, the EDC system must be able to produce an audit trail to show who entered and modified data, when, and what was changed. This is important to ensure compliance with regulatory requirements and to provide transparency in the trial process.

In summary, there are different types of EDC systems that can be used for clinical trials, including web-based, cloud-based, standalone, hybrid, custom, and integrated systems. The choice of EDC system will depend on the specific needs of the trial, including the size and complexity of the trial, the data collection requirements, budget, user-friendliness, technical support, security, and audit trail capabilities.

What are the common EDC systems available in the market?

There are several common Electronic Data Capture (EDC) systems available in the market that are widely used in clinical trials. Some of the most popular EDC systems include:

Medidata Rave: This is a web-based EDC system that is widely used in the pharmaceutical and biotech industry. It provides a comprehensive data management solution that includes features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
Oracle Clinical: This is a web-based EDC system that is widely used in the pharmaceutical, biotech and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
Inform: This is a web-based EDC system that is widely used in the pharmaceutical, biotech and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
Medrio: This is a web-based EDC system that is widely used in the pharmaceutical, biotech and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
OpenClinica: This is an open-source, web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
Castor EDC: This is a cloud-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities.
Clincapture: This is a cloud-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as electronic medical records (EMRs) and laboratory information management systems (LIMS).
MedNet Solutions: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
eClinicalOS: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
Velos eResearch: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
Clincapture: This is a cloud-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as electronic medical records (EMRs) and laboratory information management systems (LIMS).
MedNet Solutions: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
eClinicalOS: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
Velos eResearch: This is a web-based EDC system that is widely used in the pharmaceutical, biotech, and medical device industry. It provides a comprehensive data management solution with features such as real-time data validation, data reporting and analysis, and electronic signature capabilities, and also allows for integration with other data sources such as EMRs and LIMS.
Veeva Vault EDC from Veeva: Veeva Vault EDC is a cloud-based electronic data capture (EDC) system offered by Veeva Systems. It is designed specifically for the life sciences industry and provides a streamlined solution for collecting, managing, and reporting clinical trial data.

It’s worth noting that this list is not exhaustive, there are several other EDC systems available on the market, and new systems are constantly being developed to meet the evolving needs of the industry. Additionally, some companies also offer customized EDC solutions that can be tailored to the specific needs of a trial.

When choosing an EDC system, it’s important to consider not only the features and functionality of the system, but also the vendor’s reputation, the level of customer support provided, and the system’s compliance with regulatory requirements. It’s important to evaluate the system in the context of the specific needs of the trial, and to choose a system that will provide the necessary support for the trial and meet the regulatory requirements.

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