Electronic data capture (EDC) software replaces the traditional and very manual process of managing clinical trial data with an electronic system. At its core, EDC software streamlines the collection, review, and processing of clinical trial data. Clinical trial management software is bolstered by EDC software; some even offer EDC functionality within the CTMS. Benefits of using EDC software include improved data quality and study efficiency, as well as an improved ability to meet regulatory compliance. Contract research organizations (CROs), clinical trial sponsors, and study sites all utilize EDC software.
To qualify for inclusion in the EDC category, a product must:
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The only Electronic Data Capture (EDC) system designed specifically for Medical Devices & Diagnostics. A complete electronic data collection toolbox for Post-Market Clinical Follow-Up (PMCF), Pos
More than just an electronic data collection (EDC) tool, Medrio’s clinical data management system (CDMS) combines an intuitive user interface and comprehensive data management in a single solution to
Castor is a leading provider of decentralized and hybrid clinical trial solutions to democratize research. With the highest-rated eClinical platform for decentralized and hybrid clinical trials, Casto
At CRScube, we’re on a mission to make clinical trials more accessible, efficient, and impactful. By providing intuitive eClinical technology, we empower researchers to accelerate medical breakthrough
Viedoc streamlines clinical trials with a powerful, web-based eClinical suite centered around EDC. Designed for efficiency, compliance, and seamless collaboration, our feature-rich platform accelerate
Medidata Rave is a cloud–based clinical data management system used to electronically capture, manage, and report clinical research data. It enables the user to record patient information (ie, visit,
Oracle Remote Data Capture provides a single application and infrastructure for electronic data capture and clinical data management.
Mednet is a leading healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Pharmaceutical, medical device, biotechnology and Contract Resear
ResearchManager Clinical Research Suite Clinical Data Management: •EDC (Electronic Data Capture) •ePRO (electronic Patient-Reported Outcomes) •RTSM (Randomization and Trial Supply Management) •
REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with
Discover Vial EDC, the cloud-native Electronic Data Capture (EDC) platform that combines exceptional performance with a user-friendly design for clinical research. Supercharged by Vial eSource, the Vi
The OpenClinica Enterprise Edition is an enhanced, fully-supported build that is ideal for mission-critical settings.
Prelude is your site's preferred EDC system. Built with the end-user in mind, Prelude is the most user-friendly data capture system in clinical research. Focus on what really matters, and spend less t
An Award Winning AI-enabled and Integrated Electronic Data Capture Software Clinion EDC is the most Integrated Electronic Data Capture(EDC) System in the Industry making your clinical trials faster a
TrialKit is an advanced eClinical platform designed to simplify and streamline data collection and study management in clinical research. This comprehensive solution caters to the needs of sponsors, C
Drug Safety Triager is our GxP validated and audit-ready pharmacovigilance (PV) literature review software solution, created from the ground up to monitor literature for Individual Case Safety Reporti
Axiom Fusion eClinical Suite is the most adaptable, Unified Platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Choose from 15+ unified modules on
Teamscope is a data collection app for field and clinical research. Create powerful mobile forms, capture data when offline and visualize it with a few clicks. With Teamscope you can build powerful f
Track.Health is an one-stop shop for data acquisition for your clinical study or clinical trials. Capture EDC and eCOA data in a single, easy-to-use, centralized platform. Implement remote enrollment,
Biotech, pharmaceutical and academic are tired of paper processes, excel sheets and unusable applications. There is an increased momentum not only to digitize, but to actually transform clinical and b
Clincase is an end-to-end EDC and clinical data management system providing a complete and integrated environment for the implementation, testing, and conduct of clinical trials for CROs, biopharmaceu
GoResearc is a fully validated internet platform for electronic data capture (EDC) for research projects such as clinical/observational studies and registries of patients.
PatientIQ is the largest and fastest-growing healthcare technology partner for deriving actionable insights from patient outcomes data. The PatientIQ platform empowers health systems, specialty practi
Bioclinica EDC equips study teams with easy-to-use tools for quick and efficient data collection right at the source on any device or desktop. A built-in survey tool makes it convenient for subjects t
MACRO promotes synergy between clinical research and practice, driving a virtuous circle of continual improvement in best practice.
Climedo’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have develo
We have a Cloud-based easy to use, regulatory Compliant, end-to-end Electronic Data Capture (EDC) / eCRF system. Which manage all clinical data management aspects including Study Planning, Study build
MATRIX EDC is a cloud-based clinical data management application. EDC supports electronic, paper-based or hybrid studies.
Yonalink’s EDC is scalable and flexible enough to manage clinical data for any trial type, regardless of geographic location, therapeutic area, size, or phase.
Forte EDC supports leading academic research centers, cancer centers, and health systems in running successful and compliant IITs.
Mahalo Health is a modern, patient-centric clinical trial platform that aims to transform the way clinical trials are managed. It combines advanced technology and user-friendly tools to streamline pro
Complex eClinical Solution for EDC/ERT/eCOA that significantly speeds up the start of clinical trials (up to 5 days), saves budget (up to 80% for monitoring), increases the capitalization and attracti
Improving quality of care and outcomes for cancer patients requires collaboration between Physicians, Scientists and Healthcare Institutions.
OnlineCRF is an electronic system for data collection in clinical trials (EDC system). It contains different modules and tools, which help to collect data and easy to manage clinical trial progress. O
secuTrial is a professional, entirely browser-based GCP-compliant EDC system for collecting patient data in clinical or non-interventional studies and patient registries.
Trialize offers an advanced automation platform for clinical trials, designed to improve study build times by a factor of four and reduce manual work by as much as 73% (comparing to market-leading CTM
Zelta (formerly IBM® Clinical Development) is a unified, cloud-based Clinical Data Management System designed to help reduce the cycle time to start, amend, and manage clinical studies — enabling life
ClinCapture provides a powerful eClinical platform that enables sponsors and CROs to rapidly build and deploy studies, lower clinical trial costs, and streamline data capture processes. Offering a hos
A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution.
Clinion’s award-winning eClinical platform offers a unified suite of solutions—including EDC, RTSM, CTMS, eCOA, and Document Automation—designed to streamline and accelerate every aspect of clinical t
Clireo eTMF is supported by a complete cloud-based document management system to facilitate any eTMF business process. Clireo eTMF includes inspector portal, workflow, version control, document stagin
The CLIRINX platform has been designed specifically for medical research conducted at academic institutions. Patient enrollment and data collection use sophisticated web-based forms.
Dacima Clinical is an advance electronic data capture (EDC) and clinical data management system (CDMS) for capturing, managing and reporting clinical research data and optimizing data collection by ef
DSG’s award-winning eCaseLink software is the most advanced EDC solution in the industry. eCaseLink 8.2 is a truly integrated eClinical solution that seamlessly combines CTMS, EDC, IWRS and Safety int
Ennov Clinical Software Suite is an end-to-end solution for managing all aspects of clinical trials, from planning through execution and close-out. Designed for sponsors, CROs, investigators, and pati
iCollect is a versatile platform developed for Health Care Solutions. It provides technology support for healthcare, clinical & lab management to handle day-to-day manually driven logistics and di
i-CDMS is a cloud based system offering a complete set of features for streamlining trial monitoring and data entry with e-CRF.
JNPMEDI Inc. is a South Korean technology company founded in 2020, that develops and services ‘MavenClinicalCloud’, a SaaS (software as a service) for clinical trial operation and data management. We
mEDC is a web based electronic data capture system that offers faster study setup, flexible configuration, detailed reporting, improved query management, all leading to enhanced user experience.
Med-Quests unique approach to collecting data means serious time savings for you and your team.
Signals Screening is an intuitive, configurable, and flexible screening workflow processing engine on top of the unparalleled data visualization and analysis capabilities of TIBCO Spotfire.
A web-based solution that can be used for recruiting patients and managing all aspects of data associated with clinical research.
SyMetric offers cloud-based, end-to-end solutions for Clinical Research, from Manufacturing to the Submissions. The Product suit is built as an ERP, on a single database providing a seamless flow of d
The Observer XT is the professional and user-friendly software package for the collection, analysis, and presentation of observational data.
YPrimes eCOA platform for patient data collection is fundamentally different than what any other providers in the industry can offer. The first and only application-based eCOA platform gives unprecede
4K mediforms is an Electronic Data Capture (EDC) system for clinical trials. The cloud-based system streamlines data collection with features like electronic case report forms, electronic patient repo
ALPHADAS® is a compelling end-to-end software solution that expedites key drug development decision making and provides operational savings throughout the business. Key benefits include: • Optimized
CapTrial is a cutting-edge software solution designed to revolutionize the way clinical data is managed. By leveraging the power of artificial intelligence and advanced data processing, CapTrial seaml
Comprehensive SAS based clinical data management, EDC, and clinical trials reporting system
Electronic Data Capture software streamlines the gathering of trial patient data for early to late-stage clinical research phases, as well as post-approval studies. An adaptable and scalable EDC syste
A new breed of cloud-based, patient-centric data capture solutions designed to handle both ePRO and EDC on BYOD.
Streamline your clinical studies with ClinVigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-market
Cloudbyz EDC is a cloud-native solution with an intuitive interface that is designed to store and manage clinical data effectively throughout a clinical trial’s life cycle. Our innovative solution ena
Cronos is a clinical trial management software
DADOS makes it easy for patients to fill out questionnaires directly on their tablet, from which clinicians and researchers can retrieve this information and build custom reports.
Join the New Clinical Trial Experience. Datacapt is a next-generation unified EDC platform designed for CROs, Sites, Sponsors and Participants in the Medical Device, Biotech and Pharmaceutical indust
DATATRAK provides industry-leading digital software for clinical trials. Responsive to the needs of each unique trial, we simplify the management of data for modern trials. Clients can make informed d
DF mTrials AI, EDC with Randomization and ePRO is a modern SaaS solution that can get you started on your clinical trial much faster than other tools in the market. The fully configurable product does
Di-EDC is an Electronic Data Capture for clinical research made especially for researchers to manage Clinical Research Projects in a compliant environment. Increase your productivity using an intuitiv
Digitalis is an innovative data collection tool (Electronic Data Capture). Digitalis provides you with all the tools you need for a pleasant and complete collection and management of quality clinical
RetinAI's Discovery for Clinical Studies is a comprehensive platform designed to streamline and enhance the management of clinical trials, particularly in ophthalmology. By centralizing data collectio
DISTILL is a spin-off from a very large IT group from Chennai, India, specialized in NO CODE platforms. DIY EDC & ePRO, drag & drop easy setup. No IT skills needed. Setup the CRF in 2 hours,
Partnerships fuel scientific advancements. Whether you are working together across hallways or international borders, DNAnexus Portals™ deliver a secure, fit-to-purpose, branded, online workspace that
Encapsia streamlines the capture, management and reporting of clinical trial data using any mix of eSource or EDC. This revolutionary platform gives you real-time access to all your data with actionab
Easily design and capture multi-centric clinical study data with a single comprehensive software. EDC software significantly streamlines randomization, study design, consistency tests, medical coding
A complete system for creating, deploying, and administering custom data entry applications.
EvidentIQ is an innovative software solution that facilitates clinical trial data management and documentation for investigators, sites, CROs and sponsors. EvidentIQ EDC enables electronic data captur
Fastrial is ideally suited for start-ups and mid-size companies alike to manage their international trials. Fastrial comes with a set of predefined easy to use libraries. Users can customize and modif
Florence Healthcare's StudyOrganizer is a powerful product designed to streamline and optimize clinical trial management. This tool supports trial coordinators in efficiently organizing study document
FormsCenter allows you to gather and track data in a clear, consistent and mandated way, whether you are collecting information from external sources, internal employees, or 3rd party software. Integr
Search and Analyze Clinical Trials for Free
Create and use better clinical patient data in your EHR. IMO Core is a problem-oriented clinical workflow solution that simplifies provider documentation and problem list management, while making
Inductive EDC is a cost-effective & compliant platform to help you collect, analyse and manage clinical trials data in mammoth quantity reducing your dependency on the paper-based process. IEDC r
inProcess Research is a SAAS platform for turning ideas into results. Stakeholders in research are all invited onto the platform to foster collaboration. Agile adaptation of modern components overcome
Jeeva eClinical cloud helps clinical researchers, patient advocacy groups, clinical research organizations (CROs), public health research organizations, and Biopharmaceutical sponsors to accelerate re
Clin’form is a unique fully integrated platform to collect and manage eCOA data in clinical trials. Clin’form offers complementary patient-centric features to support at home and on-site clinical tria
KlindatTM is a next-generation electronic Case Report Form (eCRF) for the pharmaceutical, biotech & medical device industries
ArisGlobal’s LifeSphere platform is a suite of unified cloud solutions that helps hundreds of global life sciences companies accelerate development, maintain compliance and streamline collaboration be
The main benefit of Marvin compared to other EDC products is the fact that it is built on the CDISC standard from the ground up and fully utilizes the advantages this offers throughout the Clinical Da
Medidata is powering smarter treatments & healthier people with digital solutions for clinical trials. Celebrating 25 years of technological innovation across 35,000+ trials & 10 million patie
Now streamline the collection of trial patient data, that supports early to late-stage clinical development phases and post-approval trials. With Octalsoft’s flexible and scalable EDC solution acceler
Ofni Clinical is a clinical data management tool that rapidly creates and implements secure, regulatory compliant clinical trial databases.
OpenEvidence is a medical information platform designed to assist healthcare professionals in navigating the vast and rapidly expanding body of medical research. Originating from the Mayo Clinic Platf
PerkinElmer SignalsTranslational, brings together all translational data into a single platform a complete precision medicine solution, from data acquisition to biomarker validation. Integrate and an
Prism is a fully integrated clinical trial management and EDC product that provides both standard data management functionality and value-added tools for clinical trial management. Prism combines ease
A Powerful, All-In-One Pre-Clinical Lab Solution From handling simple to complex GLP and non-GLP compliant laboratory environments, Xybion's enterprise solution for pre-clinical data management solut
Protocol First is the first EDC that specializes in collecting response data and detecting safety signals.
rMark Bio helps life sciences companies solve for the complexities that come with digital transformation by delivering collaboration decisions and key scientific insights that evolve based on a compan
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
