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Company description

Fountayn, operating under the Datatrak brand, develops and provides a fully integrated eClinical software platform for clinical trial data management. Founded in 1991 as Datatrak International — the first company to offer electronic data capture — Fountayn has accumulated over 30 years of experience in the field and has supported more than 10,000 studies across 83 countries and 6 continents. The platform serves global sponsors, contract research organizations (CROs), life sciences professionals, pharmaceutical companies, and biotechnology firms, and has been used in multiple studies that have received FDA approval.

The core platform is a cloud-based, unified eClinical system built from a single source code, enabling all clinical trial participants and patients to access it in real time from any device worldwide. It is validated as compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP standards, and supports multiple languages. The system is designed to be highly customizable, accommodating studies ranging from rapid startup configurations to complex, large-scale trials.

Core Products and Modules

• EDC/CDMS (Electronic Data Capture / Clinical Data Management System): A cost-effective, user-friendly system designed to enhance data capture and data cleaning. Includes a Rapid Startup option intended to be easy to configure and affordable. Randomization (RTSM) is natively integrated within the EDC, providing a seamless process for sites.
• eTMF (Electronic Trial Master File): A compliant, integrated document management system accessible directly from the EDC dashboard. Described as reducing costs by 62% and maintaining documents in an inspection-ready state at all times.
• eConsent / ePRO: Supports decentralized and remote clinical trial operations, including remote patient informed consent and remote patient enrollment into studies.

Platform Capabilities and Technical Details

• All modules are built from a single source code, making the system fully unified rather than assembled from separate third-party components.
• eTMF functions are accessible directly from the EDC dashboard, enabling seamless navigation between data capture and document management.
• The platform supports multilingual use and is accessible from any device worldwide.
• Supports decentralized clinical trial (DCT) functionality through remote patient access tools.
• Trial design and RTSM (Randomization and Trial Supply Management) are included within the broader product portfolio.

Support, Deployment, and Compliance

• Fountayn provides 24/7 global support for its enterprise platform, with in-house support staff reported to resolve 95% of support requests in a single call.
• The platform is deployed as a cloud solution accessible globally.
• Validated compliance with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP requirements.
• The company also offers consulting services and custom software and data solutions for healthcare, medical, life sciences, pharma, biotech, insurance, and research industries beyond clinical trials.

Experience and Track Record

• Datatrak International was established in 1991 and is recognized as the first EDC company.
• The platform has managed over 10,000 clinical studies across 83 countries on 6 continents.
• Fountayn's team collectively holds over 35 years of eClinical solutions experience, supporting trial design across all trial types, from initial requirements through testing and mid-study changes.

Fountayn positions its Datatrak eClinical Technology as a long-established, all-in-one solution for clinical data management, with a focus on integration across EDC, eTMF, eConsent, ePRO, and RTSM functions within a single compliant, cloud-based platform.

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Software attributed to Fountayn

• DATATRAK eClinical TechnologyView

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