Florence eTMF Reviews & Product Details

Designed as an end-to-end, cloud-based solution, TrialKit applies the latest in technology to enable interchangeable use of browser-based and mobile app platforms—reflecting all changes from all sources in the database in real-time.

ACE allows companies like yours to adapt and grow to meet your evolving quality management needs, without coding. With ACE™ , you will minimize the administrative hassles and maximize ROI with productivity gains from day one ‒ all while 21 CFR Part 11 compliant.

Medidata Rave is a cloud–based clinical data management system used to electronically capture, manage, and report clinical research data. It enables the user to record patient information (ie, visit, lab, and adverse event data) using forms that are customized for each study.

Kivo makes simple and affordable document management systems including RIM, eTMF, and QMS. A single license grants access to all our solutions, so you can supercharge cross-functional collaboration without breaking the bank. Fully validated, Part 11 and SOC 2 compliant, Kivo is designed forGxP.

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.