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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.

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Trusted by

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.

Our Implementation Process

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.

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Implementation Steps

Contract Signing, Receipt of Final Documents & Kickoff Meeting
Spec Gathering & Design
Validation & User Approval Testing
Improves trial QA Review & Final Approval by meeting DEI criteria with Datatrak DCT
Deployment

Integrated Solutions

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Electronic 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.

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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.

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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.

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eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

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Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with a cloud-based pharmacovigilance software platform built for compliance.

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EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

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Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

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Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

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"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user friendly, and site staff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

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.