DATATRAK eClinical Technology

DATATRAK eClinical Technology, offered by Fountayn, is a fully integrated, cloud-based clinical data management system built from a single source code. It is designed for clinical trial participants, patients, sponsors, and CROs, and supports real-time access from any device worldwide. The platform has over 30 years of validated experience and has been used across more than 10,000 studies in over 83 countries.

The system is validated as compliant with FDA CFR 21 Part 11, HIPAA, GDPR, and GCP standards. It is multilingual and highly customizable, supporting studies ranging from rapid startup configurations to complex, large-scale trials.

Core Modules

• EDC/CDMS: An electronic data capture and clinical data management system focused on data capture and cleaning. Includes a Rapid Startup option designed for ease of setup and cost-effectiveness.
• eTMF: An electronic Trial Master File system integrated directly into the EDC dashboard. Manages trial documents in an inspection-ready state and is reported to reduce costs by 62%.
• eConsent/ePRO: Supports decentralized and remote patient access to studies, including remote informed consent and patient enrollment capabilities.

Integration and Architecture

• Built from a single source code, making all modules natively integrated rather than assembled from separate systems.
• Randomization (RTSM) is natively integrated with the EDC module.
• eTMF functions are accessible directly from the EDC dashboard.
• Supports real-time data access for all clinical trial participants and patients across devices globally.

Fountayn's platform is positioned as a unified eClinical suite covering EDC, CTMS, decentralized clinical trial (DCT) tools, RTSM, and trial design, with the stated goal of accelerating the flow of clinical research data from sites to sponsors and regulatory authorities.