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EDC & Clinical Trial Solutions for Government-Sponsored Research

Government-sponsored trials and public health research get audited by people who weren't in the room when the protocol was written, and the data has to make sense to every one of them. Add multiple funding agencies, each with its own reporting format, and a study team can lose hours translating the same numbers for different audiences. Datatrak's platform gives your team EDC and the rest of the eClinical toolkit in one connected system that’s built to run compliant, multi-agency research.

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One Platform for Every Stage of Your Program

Datatrak gives government agencies and publicly funded research programs one place to manage real-time data, whether that's a single-site public health study or a multi-agency, multi-country trial. With drag-and-drop configuration, multiple controlled testing environments, and integrations, it’s built for how your team already works.

See How It Works

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FDA CFR 21
Part 11

Compliant

HIPAA

Compliant

GDPR

Compliant

GCP

Compliant

SOPs

Validated Systems

CDISC &
CDASH

SOC

Type II

EDC Built for Government and Public Health Research

Publicly funded trials answer to auditors, so every data point needs a paper trail showing where it came from and how it was collected. The first EDC established in 1991, Datatrak is a proven, highly configurable system with the longest track record in life sciences. Study teams pick it up quickly because the interface feels familiar. It's validated and compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP, giving your agency the audit-ready documentation federal oversight requires.

Centralized Data Oversight Across Every Site and Agency

Study planning, site performance, communications, payments: one location instead of a dozen disconnected systems. No more piecing together the big picture across every agency, site, or partner institution involved in the research.

Programs Built to Fit Your Requirements

Configure the next government-sponsored study with drag-and-drop design tools across multiple controlled testing environments. Streamline the research and start the program sooner, without compromising on the compliance and security your stakeholders require.

35+ years

of combined experience

10,000+ studies

managed by Fountayn

83+ countries

using Fountayn

"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

Tell us what you're trying to solve, and we'll show you how we can help.

Request a Demo

EDC & Clinical Trial Solutions for Government-Sponsored Research

One Platform for Every Stage of Your Program

EDC Built for Government and Public Health Research

Centralized Data Oversight Across Every Site and Agency

Programs Built to Fit Your Requirements

35+ years

10,000+ studies

83+ countries

Related Products

Electronic Data Capture (EDC)

Clinical Trial Management (CTMS)

Electronic Trial Master File (eTMF)

eConsent

Tell us what you're trying to solve, and we'll show you how we can help.