Fountayn's Datatrak eClinical Technology is a fully integrated, cloud-based solution designed for real-time clinical trial data management. Built from a single source code, it functions as an all-in-one system accessible by all trial participants and patients globally from any device. The system features a natively integrated EDC (Electronic Data Capture) with seamless access to eTMF (electronic Trial Master File) functions directly from the EDC dashboard. With over 30 years of experience, it is highly customizable for studies of any complexity, from rapid startup to intricate designs. The platform is multilingual and validated for compliance with FDA CFR 21 Part 11, HIPPA, GDPR, and GCP standards. It is trusted by global sponsors and CROs, having been used in over 10,000 studies across 83 countries.

Features & Benefits

• Unified Cloud Solution: Fully integrated, all-in-one system built from a single source code for seamless data management.
• Global Accessibility: Real-time access for all clinical trial participants and patients worldwide from any device.
• Integrated EDC and eTMF: Natively integrated EDC with seamless access to eTMF functions from the EDC dashboard.
• Customizable and Compliant: Highly customizable for any study requirement, multilingual, and validated for FDA CFR 21 Part 11, HIPPA, GDPR, and GCP.
• Cost-Effective EDC: Powerful, user-friendly EDC system with a Rapid Startup option that is easy to set up and affordable.
• Efficient eTMF Management: Effortlessly manage trial documents with a compliant, integrated eTMF system that cuts costs and keeps files inspection-ready.
• Decentralized Patient Access: eConsent/ePRO enables decentralized and remote patient access, informed consent, and enrollment.