Electronic Data Capture (EDC) in Clinical Trials

What does EDC stand for?

EDC stands for “electronic data capture.” While this abbreviation may seem generic in nature, it has a specific meaning in the context of clinical trials. EDC is an online trial data collection solution. An EDC system is invaluable for quicker, higher-quality, and more cost-effective clinical trials. Despite minor challenges related to infrastructure, technology, regulations, and training, its vast benefits over traditional paper-based data collection in clinical trials make it a necessary investment that will almost certainly pay off.

What is the purpose of an EDC?

An EDC is used to collect relevant trial data electronically, in contrast to traditional hardcopy data collection. EDC is the modernized, digitized equivalent to paper-based trial data storage, and its main purpose is to help investigators collect, store, and secure all trial data in a single place, making it easier for all stakeholders involved to access and view relevant information.

EDC plays an important role in streamlining and unifying the data collection process, making it faster, less prone to error, and more cost-effective. Online data entry and instantaneous query resolution produce error-free data that is synchronized across sources and sites.

Despite the well-documented benefits of adopting EDC, many clinical trial sponsors have been reluctant to change their methods. In 2001, less than 5% of clinical trials used an EDC despite the technology already having been available for 15 years.[¹] However, the pursuit of improved trial quality, shorter time to market, and reduced costs eventually led to a decline in the use of paper-based data collection methods. In 2019-2020, 81% of all phase 1 clinical trials used EDC only [²]. This drastic adoption curve of EDC technology over the past two decades indicates that EDC is proving to be both dependable and favorable for clinical trial data collection.

Here are some common functions an EDC system might perform and associated advantages of EDC:

• Logic checks to highlight discrepancies upon data entry
• Real-time data reports, ensuring safety data is updated as soon as possible
• Send queries instantaneously for faster turnaround time for data clarification
• Provide clear audit trails with data entry allowed only by authorized individuals
• Decreases transcription errors due to illegible handwriting or data entry mistakes
• Reduces time and physical storage needs associated with paper management

Our curated list of EDC solution providers can be found at the end of this article (skip ahead if you’d like), but first we will take a quick detour to briefly discuss a concept that is closely related to EDC; electronic case report forms (eCRFs).

What is an eCRF in clinical trials?

An eCRF is the electronic version of a CRF or “case report form,” a form that contains all trial-relevant data for an individual trial subject. It includes the personal information of the subject along with all safety and efficacy data pertaining to that individual collected over the course of the trial. Its purpose is to facilitate standardized data collection of protocol-required information for statistical analysis. Like EDC versus traditional paper-based data collection, eCRFs are the online version of CRFs that support more efficient data collection and storage and better data quality.

What is the relationship between EDC and eCRF?

It appears that the terms EDC and eCRF are sometimes confused. An eCRF is simply an electronic version of a case report form – the document that contains all information for each individual participant that is sent from the site to the sponsor. EDC, on the other hand, is a system for trial data collection that directly records data electronically. An EDC may collect data that will end up on the CRF or eCRF for each patient, and will have the ability to produce, fill, edit, store, share, verify, and export eCRFs. You can think of EDC as the data recording method, and the eCRF as the form that compiles this data for each participant for eventual analysis.

What are the advantages of eCRFs over paper CRFs?

Traditional paper CFRs are sent to the trial sponsors' data management (DM) site, where the DM staff processes them, completes data entry, and vets information after fixing and clarifying any incomplete data or errors. The data can only be locked when it is considered error-free. This creates a delay before the DM personnel can analyze the data. The entire process can take up to 6-9 months.[³] Sending the forms from one place to another and ensuring they are not damaged or misplaced in the process is an additional hassle.

eCRFs allow all data to be stored centrally and available for viewing instantaneously, and most have built-in validity checks to ensure information is entered correctly and completely. Said in another way, eCRFs focus on preventing errors rather than correcting them as done with traditional CRFs. Combining EDC with eCRFs – as many of the providers on the following list do – adds another layer of assurance for recording and storing data accurately and minimizing time and effort required for manual data entry and validation tasks.

Top 12 EDC/eCRF providers for clinical trials

Medidata Rave EDC

Medidata’s Rave EDC is part of the unified Medidata Clinical Cloud® platform. It integrates seamlessly with Medidata’s other systems, such as Rave eTMF and Rave CTMS, offering a comprehensive, unified suite of solutions that can be customized depending on the sponsor’s/trial’s needs. Medidata pioneered EDC development, and its system has been used in over 22,000 clinical trials involving millions of patients. Rave EDC offers real-time validation, streamlined data review, advanced data analytics, deep insights, and a highly scalable and flexible solution.

May be ideal for: Sponsors conducting multiple trials looking for a recognized and reputable provider of an integrated solution that is highly customizable.

Castor EDC

Castor EDC/CDMS is an electronic data collection solution that is built with users of all levels of technical expertise in mind, offering reliable customer care support. Castor EDC/CDMS is easy to learn and use, allowing users to create, store, and clone validated eCRFs in minutes from a premade template or from scratch with over 20 field types, with easy editing mid-trial without any data loss.

Due to its open API, Castor EDC/CDMS can easily integrate with other eClinical software, making it compatible with any systems your organization already has in place.

It is ranked in the top 5% for shortest build time, since more than 90% of studies employing Castor EDC are deployed within the first four weeks. It has been used in over 8500 trials involving 3 million patients across 90 countries.

May be ideal for: Sponsors conducting large trials who require easy API-based integration, quick deployment time, and secure data while also allowing eCRFs to be changed mid-trial.

Advarra EDC

Advarra EDC is a cloud-based data collection solution that integrates with OnCore, their enterprise-level CTMS, and is equipped with a lab results interface via FHIR (Fast Health Interoperability Resources). It prioritizes data integrity through 21 CFR Part 11-compliance. Advarra offers other solutions like eSource, eReg, and eConsent, which, in combination with the EDC platform, create a complete clinical trial management solution.

May be ideal for: Sponsors looking for a comprehensive solution that is quick to set up and gives extra attention to ensuring regulatory compliance.

Veeva Vault EDC

Veeva Vault EDC is part of the Veeva Vault Platform, working seamlessly with its other clinical operations solutions. It equips users with a visual drag-and-drop study builder, removing the need to rely on a developer. Veeva Vault EDC minimizes manual coding by facilitating batched medical coding according to MedDRA or WHODrug dictionaries with single keystrokes, using suggestions or exact-match automation. User acceptance testing (UAT) is done early on in the build and significantly accelerated via Veeva’s Agile Design. In 2023, six of the top 20 pharma companies selected Veeva Vault EDC as their standard for clinical trials.

May be ideal for: Trial sponsors who want an easy-to-use interface with robust options for customization without the need for IT personnel involvement.

Clario EDC

Clario EDC offers several scalable EDC solutions for different types of clients, including those who wish to build their studies from scratch without prohibitive costs and those who want a robust, full-featured solution from the get-go. Clario’s EDC solutions include:

• Clario Solo: This product package includes the Clario EDC license along with study builder and library services. Perfect for smaller trials/organizations that need a completely individualized product without any extra features left unused.
• Clario Control: The Clario EDC license comes with full project management and study build support services from Clario’s team of EDC experts, for clients who want a ready-to-implement solution from day one with many features.
• Clario Command: With more features than Clario Control, this suite is designed for enterprise-level operations requiring more in-depth reports. It includes the Clario EDC license along with a dedicated project manager and data manager, for a fully integrated, efficient, all-in-one solution.

May be Ideal for: Clients who require a customized yet scalable solution to match a growing enterprise.

Oracle Clinical One

Oracle Clinical One’s Unified Platform promises to consolidate data from all sources into one place for analysis and for easy access for all clinical trial stakeholders. Seamless integration with legacy systems and the broader application ecosystem, and the flexibility to scale any desired study make it an empowering EDC solution.

Oracle Clinical One Unified Platform was designed by always trying to stay ahead of the curve, asking if EDC available solutions were keeping up with the needs of modern clinical trials. This innovative attitude led them to create a robust, complete all-in-one solution for clinical trial data collection needs.

May be Ideal for: Sponsors who want to make quicker informed decisions by harmonizing data from all sources and streamlining workflows in one single system.

OpenClinica EDC

Open Clinica’s EDC platform keeps speed and efficiency in mind with its mobile-friendly monitor dashboard, drag-and-drop study design interface, a feature-rich eCRF builder and integrated eCRF data entry, and API-integrated data uploading.

OpenClinica EDC allows sponsors to manage study cameras and send site workers notifications from one place. Trusted within the clinical research industry, OpenClinica EDC has been used in 10,000 studies involving over five million patients.

May be ideal for: Sponsors who wish to speed up data entry on any device and who are looking for eCRF integration from a tried and trusted provider.

ClinCapture Captivate® EDC

ClinCapture Captivate® EDC is a scalable data collection solution with a modular format. Additional modules such as VDC®, Captivate® Coder (Medical Coding), Patient Reported Outcomes (ePRO), electronic Clinical Outcomes Assessment (eCOA), and Captivate® Randomization and Trial Supply Management (RTSM) may be added as upgrades, offering a fully integrated, all-in-one solution. Besides this modular design, ClinCapture Captivate® offers study flexibility with eCRF revisions, a drag-and-drop-build interface, and risk-based monitoring (partial and targeted source data verification).

With ClinCapture Captivate®, sponsors can build clickable forms with dynamic elements such as clickable images, either through the drag-and-drop method or manual code.

May be Ideal for: Sponsors who value simple yet complete configurability and who are looking for full integration with numerous other solutions all from the same provider.

Smart-Trial EDC

Touted as MedTech’s leading EDC software, Smart-Trial updates are released four times per year, keeping it at the forefront of the industry. The complete software solution facilitates data collection in post-market clinical follow-up (PMCF), post-market performance follow-up (PMPF), clinical investigations, and clinical performance studies. It prevents data errors with automated data entry validation and works on any device, enabling both clinical trial staff and patients to enter data easily and accurately.

May be Ideal for: Sponsors looking for a complete software solution instead of an online cloud-based solution, which is frequently updated and works on any device.

Medrio EDC

Medrio EDC allows sponsors to keep a library of reusable study templates, and boasts build times of as fast as 3 weeks. Attentive to industry requirements, Medrio made over 70 enhancements in 2022 alone across 14 products, prompted through client feedback. Their EDC is fully compatible with their other solutions like Medrio ePRO and Medrio RTSM, and works well both independently and as part of a more complete clinical trial management solution.

May be ideal for: Multi-trial sponsors prioritizing short study build and deployment times.

RedCap

RedCap EDC claims to be the industry's most advanced, secure, and scalable electronic data capture solution. It centralizes all data collected from all sites, patients, labs, and connected devices, and can also help in managing study timelines and analyzing data. Sponsors can build web-based or mobile studies from the same interface. Instead of cloning entire forms, users can copy single or multiple features, such as field validation conditions or edit checks, which makes eCRF creation a breeze. Further, users can access a global library of fields which promotes eCRF consistency and compliance with standards.

May be ideal for: Sponsors valuing data analytics capabilities and standardization of medical coding and terminology for improved consistency and compliance.

anju TrialMaster

Anju’s Electronic Data Capture (EDC) suite, Anju TrialMaster, stands out for its intuitiveness and superior flexibility and usability, and includes built-in ePRO (patient-reported outcomes) for quality data collection from any device. TrialMaster is equipped with translations to numerous languages so personnel from different regions can work on the same study together in real-time, greatly facilitating international studies.

Immediate feedback during data entry, serious adverse event reporting, built-in medical coding, flexible SDV, built-in eConsent, and actionable insights through analytics and data visualization are just some of the features of TrialMaster.

May be ideal for: Sponsors looking for an intuitive and easy to use EDC that does not compromise on functionality, with simple integration and additional built-in features such as risk-based monitoring and eConsent.

Conclusion

EDC and eCRFs are essentially becoming the norm in clinical trials. Investing in an EDC is paramount for more cost-effective, efficient, and higher-quality clinical trials with reduced manual verification of trial data. Nonetheless, choosing the right solution that works for your organization or trials is critical. Several industry-leading companies offer tried and tested EDC solutions with their own unique features, and there is a fit for every clinical trial and sponsor, regardless of its scale, complexity, and specific priorities and needs.