Key Features
NATO Security Standards
Omega’s data centers and servers adhere to NATO security standards, ensuring robust protection of sensitive clinical trial data. Implements advanced cybersecurity measures to safeguard data against unauthorized access and breaches.
FDA Compliance
Omega’s EDC systems are fully compliant with FDA regulations, including 21 CFR Part 11, which governs electronic records and electronic signatures. Ensures data integrity, audit trails, and user authentication to meet FDA requirements for clinical trials.
Secure Data Hosting
Hosting data on Omega’s dedicated servers provides unparalleled reliability and access control, minimizing risks associated with data loss or corruption. Utilizes high-performance infrastructure to support large-scale data collection and processing.
Real-Time Data Access and Analytics
Offers real-time data access for sponsors and CROs, enabling timely insights and decision-making. Provides sophisticated analytics tools to enhance data interpretation and reporting.
User-Friendly Interface
Designed with an intuitive interface that simplifies data entry and management for clinical trial personnel. Ensures ease of use without compromising on functionality or compliance.
Customization and Scalability
Offers customizable EDC solutions that can be tailored to meet the unique requirements of each clinical trial. Scalable infrastructure supports trials of all sizes, from small studies to large multicenter projects.
Comprehensive Training and Support
Provides extensive training and support to ensure smooth implementation and operation of EDC systems. Offers round-the-clock technical assistance to address any issues promptly.
Regulatory Compliance and Quality Assurance
Committed to maintaining compliance with international regulatory standards, including ICH GCP guidelines. Conducts regular audits and quality checks to ensure continuous compliance and performance.