Flex Databases eTMF

5 reviews

Flex Databases' electronic Trial Master File system offers a comprehensive, user-friendly solution for managing clinical trial documentation. Designed to provide 24/7 visibility, it ensures secure access to trial documents from any location, facilitating efficient oversight and compliance. The platform's intuitive interface allows users to quickly identify missing documents, monitor upload statistics, and assess folder completeness by various parameters, enhancing overall trial management. Key Features and Functionality: - Efficient Document Management: Users can upload documents via multiple methods, including direct email, mobile app, drag-and-drop, or WebDAV connection. Integration with Clinical Trial Management Systems ensures seamless document filing without additional effort. - AI-Powered Automation: The eTMF system incorporates artificial intelligence to automate document placement and metadata assignment, significantly reducing manual workload and minimizing errors. A co-pilot mode monitors filing accuracy, triggering human review when necessary to maintain high compliance standards. - Compliance and Security: Fully compliant with regulations such as 21 CFR Part 11 and GDPR, the system offers robust access controls, comprehensive audit trails, and secure archiving functions. It supports both cloud-based and on-premise hosting options, providing flexibility to meet organizational needs. - User-Centric Tools: Features like automated to-do lists, customizable widgets, and exportable reports help users focus on critical tasks. The platform also includes embedded eSignature functionality for document review, approval, and signing processes. Primary Value and User Solutions: Flex Databases' eTMF system addresses common challenges in clinical trial management by streamlining document handling, ensuring regulatory compliance, and enhancing operational efficiency. Its AI-driven automation reduces manual tasks, saving significant time and resources. The system's flexibility and user-friendly design make it adaptable to various organizational processes, facilitating seamless integration and improved collaboration among stakeholders.

Flex Databases CTMS

2 reviews

Processing and storage of clinical trials specific data such as sites, investigators and subjects management

Pharmacovigilance and Drug Safety

0 reviews

Flex Databases Pharmacovigilance is a comprehensive, end-to-end drug safety platform designed to support robust and fully compliant pharmacovigilance activities. It covers the full lifecycle of safety management, from clinical trials through post-marketing surveillance. Key Features: Centralized Safety Database Store and manage all safety data in a single, secure system. Ensure consistent and accurate data across trials and post-approval activities. Case Management & Triage Efficiently collect and triage Individual Case Safety Reports (ICSRs). Prioritize cases based on severity, seriousness, and regulatory requirements. Evaluation & Analysis Perform thorough safety assessments and signal detection. Generate compliance-ready reports and dashboards for safety monitoring. Regulatory Submission Streamline reporting to regulators (FDA, EMA, or other authorities). Automate submission processes while maintaining full audit trails. Integration & Compliance Fully compliant with ICH-GCP, GVP, and other regulatory standards. Integrates seamlessly with other eClinical modules like CTMS and eTMF. Benefits: Reduces manual effort and risk of errors. Enhances regulatory compliance and audit readiness. Provides a unified view of safety across all clinical programs. Supports scalability for global trials and multi-study portfolios. Use Case: From clinical trial sites to post-marketing surveillance, Flex Databases Pharmacovigilance ensures timely, accurate, and compliant safety reporting—empowering CROs and pharma companies to manage drug safety with confidence.