Learn More About Electronic Data Capture (EDC) Software
What is Electronic Data Capture (EDC) Software?
Electronic data capture (EDC) software collects and manages patient data for life sciences organizations during clinical trials, replacing traditional paper collection systems. This software improves data quality, streamlines data collection, and ensures regulatory compliance. Electronic data capture evolved from remote data entry (RDE) systems used in the 1980s, which allowed for local data collection on portable computers. EDC systems, by contrast, allow web forms to be created and accessed on the Internet, eliminating data silos and serving as a central hub for source data.
Depending on the EDC software, patient data may either be transcribed from paper forms or collected electronically at its source (e-source). This data is then saved as an electronic case report form (eCRF). Clinical trial participants may use connected devices to input responses, but study coordinators at research sites will commonly collect and manage data in the EDC system. Sponsors and contract research organizations (CROs) may also interact with the software for data verification, validation, or management.
EDC systems are most beneficial for assessing pharmaceutical and medical device safety, often in later phases of trials, but can be employed in various clinical trials. They significantly reduce the time needed for clinical study design and trial data collection while reducing human error and improving data workflows.
What are the Common Features of Electronic Data Capture (EDC) Software?
The following are some core features within EDC software that can help clinical trials manage data collection:
eCRF builder: eCRFs are intended to mimic paper forms, and EDC software provides point-and-click or drag-and-drop tools to build out case report forms and store templates for future use. Versioning allows eCRFs to be iteratively tested, with audit logs to track changes to forms over time. Collaboration tools allow multiple study and site staff to work from the same interface, building out forms exactly as they’ll appear to trial participants. eCRFs can be built to ensure erroneous data isn’t collected and specific triggers occur based on responses. Some EDC systems may also offer a library of standard form templates gathered from external sources.
Data entry and collection: Once eCRFs have been approved for use in clinical trials, data can be collected from trial participants and assigned to the right forms within the EDC system. Study coordinators can edit check data in real-time based on pre-designated protocols whenever discrepancies arise. Depending on the system, participant data can be collected from any device, with some allowing for randomization to protect clinical trial integrity. Modern EDC software also supports cloud data storage and API integration to support batch data importing and exporting.
Data validation: EDC software allows collected data to be checked against defined clinical trial protocols, ensuring both completeness and correctness of all captured clinical data. This ensures that trials are being conducted in compliance with regulatory requirements, most commonly 21 CFR Part 11. Data validation ensures no data is duplicated and that invalid data is not collected. This is often automatic within the system, preventing data that doesn’t meet all the defined parameters and formats from entering the database.
Query management: Given the complexity of clinical trials, multiple personas and stakeholders are involved in the process from start to finish. Query management features allow users in the EDC system to communicate with each other, raise and respond to questions, and address any issues with data before it is locked and finalized. Specific queries can be built into the system to trigger approval workflows, but manual queries can also be raised.
Role-based permissions: EDC software allows users to be assigned permissions based on their role, depending on if they are a site coordinator, data monitor, or another party. This promotes data security and integrity and reduces the likelihood of data tampering or breaches.
Data reporting: Data can be visualized and accessed in various formats, including dashboards, graphs, charts, and exported sheets. EDC software allows data to be imported or exported in several formats, and analytics helps measure ongoing trial outcomes. This data can be shared across different trial sites, and automatic updates can be configured in the system to send out triggers based on time or event.
What are the Benefits of Electronic Data Capture (EDC) Software?
The following are the benefits of EDC software:
Improved data quality: Electronic data capture (EDC) software promotes data quality by eliminating outdated paper systems, which slow down trials. Duplicate and invalid data could take weeks to identify before electronic systems were introduced. An EDC system allows these issues to be raised and resolved in real time and even avoided entirely depending on how the parameters for valid responses to eCRFs are built.
Quicker data collection: By consolidating data from multiple sources into one system, EDC software allows sites to complete trials quicker. Forms can be built and deployed faster, data entry is streamlined, querying and validation are resolved in real time, and data can be locked by the appropriate users—all within one system. Data can also be accessed much faster by searching within the database, allowing faster decisions to be made and for trials to be adapted as needed. EDC software unifies the various working parts that go into ideating and conducting clinical trials.
Improved data security and compliance: EDC software promotes security standards that protect sensitive health data by offering audit trails, role-based permissions for data access, and built-in regulatory compliance standards (which may include 21 CFR part 11 compliance, GDPR compliance, and ISO 27001-2013 compliance). Data access is limited based on user type, and designated trial protocols ensure adherence to data integrity throughout the data collection process. Additionally, EDC vendors ensure data is protected and backed up, with more now offering cloud storage.
Who Uses Electronic Data Capture (EDC) Software?
EDC software is used broadly across life sciences organizations, such as pharmaceutical, medtech, and biotechnology companies. There are three main personas involved in clinical trials and studies.
Sites: Sites coordinate the trial and are responsible for collecting data from clinical trial participants. These are typically hospitals or clinics, with nurses, physicians, and other designated site coordinators working to enter clinical data into the EDC system. Each trial site will have a principal investigator responsible for ensuring the site adheres to all trial protocols and reviews all collected data for approval.
Sponsors: A sponsor is an organization responsible for a clinical trial. This is typically the life sciences organization looking to have its medical product(s) approved for the market. Sponsors employ a number of staff who will work with an EDC system to monitor and manage data, conduct source data verification, and submit ongoing queries as needed to ensure data integrity.
Contract research organizations (CROs): CROs are essentially the middle-men between sites and sponsors. They are contracted by the sponsor organization to manage the clinical trial, often from planning to completion. CROs will often handle site visits on behalf of sponsors, in addition to a number of key trial management functions depending on the sponsor’s needs. CROs may use EDC software to support protocol development, clinical trial data management, data analysis, data querying, and ultimately monitor each trial site to ensure they remain compliant.
Software Related to Electronic Data Capture (EDC) Software
Related solutions that can be used together with electronic data capture software include:
Clinical trial management software: Clinical trial management software (CTMS) works in tandem with EDC software to support the project management-related trial tasks. This can include participant screening and recruitment workflows, document management, financial management, and staff monitoring. EDC software should be able to interface with a clinical trial management system, promoting data exchange.
Challenges with Electronic Data Capture (EDC) Software
Software solutions can come with their own set of challenges.
Initial implementation and adoption: Utilizing EDC software requires every site to be trained on how to use it at each role level. This can be an ongoing process repeated each time a new trial is conducted.
International compliance: If trial sites exist inside and outside the US, an EDC system may not provide all the necessary compliance support. For in-house designed EDCs, this is even more likely.
Browser compatibility: Since EDC software is web based, browser compatibility and security are essential. A stable internet connection and uninterrupted access to a particular browser are needed, as well as data privacy standards depending on the browser.
Which Companies Should Buy Electronic Data Capture (EDC) Software?
While EDC software users fall under the three personas of sites, sponsors, and CROs, the companies prompting the trials fall under the broader life sciences umbrella.
Pharmaceutical companies: Pharmaceutical companies involved in clinical trials use EDC software to collect data around drug testing. This is important in later phases of trials where pharmacovigilance matters.
Medtech companies: Medtech companies collect trial data with EDC software to ensure medical devices operate as intended and provide the advertised benefits. This extends beyond clinical trials and into post-market safety surveillance as well, once devices have been made available to the general public.
Biotech companies: Biotech companies that don’t fall under pharmaceutical or medical device development may also use EDC software in their clinical research trials. Vaccine testing is one important example where multiple trial phase data collection is important for getting vaccines approved. Biotech companies conducting other R&D trials rely on EDC software to ensure ethical testing.
How to Buy Electronic Data Capture (EDC) Software
Requirements Gathering (RFI/RFP) for Electronic Data Capture (EDC) Software
Whether a company is just starting to explore electronic data capture (EDC) software or is looking for a more appropriate solution for their needs, G2.com can help inform buyers of the market and assist them in selecting the best software product for their business.
For EDC software, the core functionality does not differ much across products. They promote data capture and validation and will likely only differ in areas such as cloud storage, device compatibility and integrations, and advanced user permissions. Buyers should consider what is working and not working with their current EDC system and use that as a starting point. Some of the questions to explore could be—does the organization need a different EDC to integrate with its existing clinical trial management tools? Does the current system lack key data management features? Is the current system too complex for certain users?
Compare Electronic Data Capture (EDC) Software Products
Create a long list
The first step to finding the perfect software solution is to create a preliminary list of products that fit the buyer’s general needs. The next step is to narrow down the list by selecting specific features that are must-haves or requirements for the buyer. G2.com provides information about the best electronic data capture (EDC) software, allowing buyers to filter options and user reviews to help narrow the product list to a more relevant selection.
Create a short list
Creating a short list of software products is an important step in the buying process. While it may be daunting to filter through various products, users can get help by utilizing G2’s compare feature. This feature will take products of choice and display them side by side so the buyer can easily determine which software ticks the important boxes on the list.
Conduct demos
Once the buyer has narrowed down the product list, the next step is to conduct a demo. Demos allow buyers to see a product and its features in more detail. To ensure a buyer gets the most out of a demo, it’s important to go in prepared. Buyers should be prepared to thoroughly test each product from the perspective of multiple trial users. Some of the questions to keep in mind would be how intuitive is the system for site staff as opposed to sponsor or CRO staff? How elaborate are the eCRF design features? Additionally, buyers should inquire about cost, integrations, vendor support, and any concerns they have about the product. Adequate preparation will make it easier for a buyer to compare products after completing the demos.
Selection of Electronic Data Capture (EDC) Software
Choose a selection team
A combination of sponsor and CRO staff will most likely be involved in selecting the appropriate EDC software for trial use, as they have the biggest stake in ensuring trials are completed satisfactorily. This will include higher-tier roles involved in data management and validation but may also ultimately fall upon the CRO’s recommendation if the sponsor defers to their expertise.
Negotiation
Once the selection team has narrowed down their software picks, it’s time to discuss customization options, pricing, and the type of support needed from the vendor. It’s always important to address pricing options, even when they are listed on a vendor’s website. Many software vendors will provide discounts and custom pricing options based on what the buyer is looking to purchase.
Final decision
Once a buyer has made the final decision on a product and is ready to move forward with a purchase, it is recommended to conduct a final demo, enquire about a trial run, and determine the next steps if the product doesn’t ultimately fit their needs. These steps can give a buyer an additional sense of security and confidence when making a final decision.
