Alcedis eCRF is a powerful electronic data capture (EDC) system designed to streamline clinical trial workflows by integrating data capture, safety management, site oversight, clinical operations, and logistics into a single platform. It enables efficient data handling at the point of experience and supports all relevant processes in one unified system. The platform is built on a validated microservice framework architecture, allowing for quick system setup and scalability. From initial specification to user acceptance testing (UAT), Alcedis provides expert support to ensure a high-performance environment for clinical research.

Features

• Real-Time Data Validation: Smart and automated validation reduces up to 80% of manual data cleaning efforts. Patient data is easily monitored through modern, lucid interfaces tailored for power users such as Clinical Research Associates (CRAs), data managers, and project managers.
• Role-Based Access & Audit Trails: Ensures full transparency and secure data handling with granular access control and comprehensive audit logs.
• User-Adaptive Dashboards: Customizable dashboard instruments provide valuable oversight of site activities, patient recruitment, documentation completeness, milestone tracking, and more.
• Elastic Semantic Search: Enables dynamic and fast retrieval of critical information, helping users find answers to important questions quickly.
• In-App Bookmarking: Allows users to keep the most relevant information visible and accessible at all times.
• Forecasting & Alerts: Built-in forecasting systems and alerts help ensure that studies remain on track and milestones are met.
• Reporting Toolbox: A configurable and powerful reporting suite allows users to generate real-time reports for risk-based study conduct, interim analyses, and statistical evaluations. Reports are available in multiple formats for easy visualization.
• Push Notifications: Keeps users informed of relevant study events, ensuring timely responses and actions.
• AI & ML-Powered Analytics: Utilizes artificial intelligence and machine learning to detect hidden adverse events (AEs), anomalies, and missing critical data. Features include intelligent coding (term recognition), forecast modeling (e.g., recruitment and potential analysis via imputation), and pre-diagnostic capabilities.
• Security & Compliance: Alcedis eCRF guarantees the highest level of security and compliance with international standards including ICH GCP, GAMP 5, GDPR, HIPAA, and FDA regulations.

Benefits

• Efficiency: Automation significantly reduces manual data cleaning, saving time and resources.
• Transparency & Control: Role-based access and audit trails ensure secure and transparent data management.
• Custom Oversight: Dashboards and alerts provide real-time visibility into study progress and performance.
• Advanced Insights: AI-driven analytics uncover hidden risks and improve data quality.
• Flexible Reporting: Easily generate and visualize reports tailored to study needs.
• Rapid Deployment: Microservice architecture enables fast setup and scalability.
• Expert Support: Alcedis experts guide users through every phase of implementation.
• Regulatory Confidence: Built-in compliance with global standards ensures peace of mind.