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Unified, Intuitive EDC and Clinical Trial Data Management

Datatrak, powered by Fountayn, gives clinical teams one connected platform to manage trial data with more speed, visibility, and control. With EDC, eTMF, CTMS, ePRO, and eConsent built into a single cloud-based system, you can cut down on disconnected workflows, reduce manual friction, and keep studies moving without the usual platform sprawl or added cost.

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An all-in-one clinical data management system, fully integrated in a cloud solution.

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FDA CFR 21
Part 11
Compliant
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HIPAA
Compliant
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GDRP
Compliant
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GCP
Compliant
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SOPs
Validated Systems
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CDISC &
CDASH
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SOC
Type II

EDC/CDMS

Our EDC/CDMS gives you a powerful, easy-to-use platform with a Rapid Startup option that gets studies up and running fast without blowing up your budget.

Explore EDC Software  →

eTMF

Our integrated, compliant eTMF system keeps everything organized, inspection ready, and accessible from your EDC dashboard while cutting costs by 62%.

Explore eTMF Software  →

eConsent / ePRO

Our integrated eConsent and ePRO solutions remove barriers to remote consent, enrollment, and study participation for decentralized and remote trials.

Explore eConsent & ePRO  →

35+ years

of combined experience

10,000+ studies

managed by Fountayn

83+ countries

using Fountayn

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Our Solutions

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.

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.

ePRO / eCOA / eSource

Collect electronic patient-reported outcomes with ePRO software natively linked to EDC and RTSM for a fully unified data experience.

Adjudication, Imaging, & Data Import

Analyze, anonymize, and import clinical imaging and data files — any format — with automatic PHI protection and real-time quality checks.

RTSM/IWRS

Manage randomization and trial supply with an RTSM/IWRS systemnatively integrated with EDC for seamless, real-time control.

Central & Local Lab Import

Import lab data from central or local labs directly into your eCRF with automated quality checks and PHI anonymization.

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.

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology terapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intiutive 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. They system is easy to use, you can create customized forms, manage study participants, securly 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 frienidly, and site stasff 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

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

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Founded in 1991, Datatrak International has pioneered and led the electronic data capture industry.

Our goal is to intelligently apply technology to improve healthcare for society in order to provide a healthy and prosperous future for everyone.

Meet The Team

News & Insights

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