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Clinical Trial Solutions for Medical Device and Diagnostics

Medical device and diagnostic trials come with their own set of demands. Datatrak gives your team the features and optional add-ons to stay prepared, move faster, and keep complex medical device clinical trials on track. Our eClinical platform is built to handle the full trial lifecycle, with the flexbiility to fit any study design and the compliance framework to back it up.

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One Platform for Every Stage of Your Study

Datatrak's flexible, scalable medical device clinical trial management platform gives teams a centralized location to host real-time data across all their studies. Whether you're running a single-site feasibility study or a multi-center pivotal trial, the platform adapts, with drag-and-drop configuration, multiple controlled testing environments, and the integrations your team actually needs.

See How It Works

Cleanroom technicians inspecting medical device with tablet

FDA CFR 21
Part 11

Compliant

HIPPA

Compliant

GDRP

Compliant

GCP

Compliant

SOPs

Validated Systems

CDISC &
CDASH

SOC

Type II

Stay Compliant with Regulatory Submissions

Track and store relevant documents in a structured, audit-ready environment. Build customizable checklists to manage tasks, stay on top of deadlines, and complete submissions on time.

Clear Insights Into Trial Management

Manage study planning, site performance, site communications, and payments all from one centralized location. No switching between systems, no losing the bigger picture.

Studies Built to Fit Your Needs

Configure your next study with drag-and-drop design features across multiple controlled testing environments. Get to first patient faster without compromising on control.

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 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

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

Request a Demo

Clinical Trial Solutions for Medical Device and Diagnostics

One Platform for Every Stage of Your Study

Stay Compliant with Regulatory Submissions

Clear Insights Into Trial Management

Studies Built to Fit Your Needs

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.