PhlexTMF

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PhlexTMF is an advanced electronic Trial Master File (eTMF solution designed to ensure the completeness, timeliness, and accuracy of clinical trial documentation throughout the study lifecycle. Developed by Phlexglobal, a recognized authority in TMF best practices, PhlexTMF integrates cutting-edge artificial intelligence to enhance document management efficiency and reduce inspection risks. Key Features and Functionality: - AI-Assisted Document Management: Utilizes pre-trained AI to prevent misfiling and metadata errors during document upload, significantly improving TMF quality and compliance. - Simplified Study Setup: Offers intuitive setup processes that capture unique trial parameters, ensuring consistent and accurate document filing standards. - Comprehensive TMF Exporting: Facilitates seamless transfer of TMF content, metadata, audit trails, and e-signature information between organizations and systems. - User-Friendly Interface: Features a combination of tree and search navigation, providing flexible document location options preferred by auditors and inspectors. - Event Management: Tracks study changes, such as protocol amendments, and monitors document collection and quality control events to verify completion. - Intelligent Placeholders: Defines expected documents, driving completeness metrics and simplifying uploads by reducing the need for extensive data entry. - Oversight and Reporting: Offers configurable dashboards with heatmap visualizations to monitor TMF timeliness and quality dynamically. - Quality Review Tools: Enables regular, risk-based, or milestone-driven completeness reviews to maintain ongoing TMF health. - Process Management: Provides flexible workflows guiding documents from upload to inspection readiness. - eQuery Tracking System: Identifies, communicates, and tracks remediation of TMF issues, consolidating all relevant information in one place. - Wizard-Driven Completeness: Visually identifies missing documents in real-time across various trial dimensions, enhancing oversight. Primary Value and User Solutions: PhlexTMF addresses the critical need for efficient and compliant TMF management in clinical trials. By integrating AI-driven automation, it reduces manual workload, minimizes errors, and accelerates document processing. This leads to improved inspection readiness, reduced risk of regulatory findings, and allows study teams to focus on core clinical activities. The solution's comprehensive features ensure that organizations can maintain a high-quality TMF with less effort, providing peace of mind and operational efficiency.

PhlexRIM

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PhlexRIM is a comprehensive Regulatory Information Management (RIM solution designed to streamline and enhance regulatory processes for life sciences organizations. It offers a centralized platform that integrates various regulatory activities, ensuring compliance and improving operational efficiency. Key Features and Functionality: - Centralized Regulatory Data Management: Consolidates all regulatory information into a single repository, facilitating easy access and management. - Submission Planning and Tracking: Enables efficient planning, tracking, and management of regulatory submissions across different regions and products. - Compliance Monitoring: Provides tools to monitor compliance status, ensuring adherence to regulatory requirements and timelines. - Document Management: Offers robust document management capabilities, including version control, audit trails, and secure storage. - Reporting and Analytics: Delivers comprehensive reporting and analytics to support informed decision-making and strategic planning. Primary Value and User Benefits: PhlexRIM addresses the complexities of regulatory information management by providing a unified platform that enhances visibility, control, and compliance. It reduces manual efforts, minimizes errors, and accelerates time-to-market for new products. By centralizing regulatory data and processes, PhlexRIM empowers organizations to efficiently manage their regulatory obligations, ensuring timely submissions and adherence to global regulatory standards.