Electronic Data Capture (EDC) System
Complex studies need an EDC that doesn’t slow down your team. Datatrak is a proven, highly configurable system built to support demanding clinical trials with the reliability, familiarity, and compliance required to keep work moving. Its user interface is familiar to clinical and site professionals because no other EDC has a longer history of use in life sciences.
Built on the first electronic data capture system established in 1991, Datatrak's EDC software has supported successful clinical trials that achieved FDA approval. The platform is validated and compliant with FDA CFR 21 Part 11, HIPAA, GDPR, and GCP, with the flexibility to meet complex study requirements.
Extensive Trial Design Capabilities
Work with our team of Trial Designers to create the study as needed to improve and enhance the end user experience.
Easy Mid-Study Change Implementation
We take pride in our one-of-a-kind process that can allow teams to implement changes without any required study downtime or data migration.
Innovative Reporting
Powerful reporting gives study teams the ability to easily access, filter, and export real-time study data into clear and concise reports whenever they are needed.
From Kickoff to Deployment in Five Steps
Datatrak is dedicated to empowering our clients with an electronic data capture platform that makes collecting clinical trial data as simple as possible. Our goal is for our clients to have efficient and successful studies by using a platform made specifically with them in mind.
Request a DemoImplementation Steps
Contract Signing, Receipt of Final Documents & Kickoff Meeting
Spec Gathering & Design
Validation & User Approval Testing
Improves trial divaQA Review & Final Approvalersity by meeting DEI criteria with Datatrak DCT
Deployment
Integrated Solutions
View All SolutionsElectronic Data Capture (EDC)
A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.
Clinical Trial Management (CTMS)
Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.
Electronic Trial Master File (eTMF)
Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.
eConsent
Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.
Post Market Surveillance
Conduct post-market surveillance and Phase IV studies with acloud-based pharmacovigilance software platform built for compliance.
EMR/EHR
Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.
Trial Design
Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.
Data Management
Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.
Frequently Asked Questions
What is an electronic data capture (EDC) system in clinical trials?
An electronic data capture system is the software used to collect, manage, and store clinical trial data in digital form instead of on paper. Datatrak’s EDC has been powering clinical trials since 1991, giving study teams a FDA CFR 21 Part 11, HIPAA, GDPR, and GCP compliant platform with a proven track record of studies that have obtained FDA approval. Its user interface is familiar to clinical and site professionals because no other EDC has a longer history of use in life sciences.
How does Datatrak’s EDC software handle mid-study changes?
Changes happen in virtually every study, and Datatrak’s EDC is built to absorb them. We take pride in our one-of-a-kind process that allows teams to implement changes without any required study downtime or data migration. Protocol amendments, form updates, and workflow adjustments can be rolled out while your study keeps moving, with no disruption to sites or data collection.
What does the EDC implementation process look like?
Datatrak’s five-step process takes you from kickoff to deployment in a predictable sequence: contract signing and kickoff meeting, spec gathering and design, validation and user approval testing, QA review and final approval, then deployment. Our Trial Designers work alongside your team throughout the process so the platform reflects your protocol, your workflows, and the experience you want your end users to have.
News & Insights
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Increase Diversity in Clinical Trials
Discussions around improving diversity in clinical trials have been ongoing for quite some time, with relatively gradual change to actual practice.
Finally Fountayn
In early 2022, we made the concrete decision to transition away from the Datatrak name and brand and rebrand to a fresh and modern look.
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The clinical trials industry is known for it’s extensive use of acronyms, which can often be confusing for those not familiar with the field. With numerous regulatory bodies, organizations, and medical terms, it’s no wonder that the industry has a vast array of acronyms. These are used to describe everything from medical conditions to regulatory documents to save time and simplify communication.
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