LifeSphere EasyDocs

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LifeSphere EasyDocs is an advanced cloud platform architected to streamline enterprise document management and ensure the continuity of business processes across the end-to-end drug development lifecycle. The enterprise-level platform is highly configurable and unified with the LifeSphere Regulatory and LifeSphere Clinical platform suites to manage content and process workflow spanning regulatory dossier (eCTD), electronic trial master file (eTMF), site initiation packages, and more.

LifeSphere

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LifeSphere is an end-to-end life sciences platform, using ArisGlobal’s proprietary Nava® cognitive computing engine to automate all core functions of the drug development process. Offering simple integration with our next-generation LifeSphere EasyDocs document management solution across the product lifecycle, the LifeSphere platform helps life sciences companies reduce time to market, increase compliance and lower drug development costs.

LifeSphere eTMF

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LifeSphere eTMF is an advanced electronic Trial Master File system designed to enhance collaboration and efficiency in clinical research. By supporting the TMF Reference Model standard document types and the eTMF Exchange Mechanism Standard, it enables seamless, real-time file sharing among sponsors, CROs, and clinical sites. This ensures that all stakeholders can contribute to the Trial Master File as a single source of truth, leading to higher quality, more complete, and timely documentation. Key Features and Functionality: - Real-Time Collaboration: Facilitates immediate updates and sharing of documents across all clinical trial stakeholders, enhancing communication and reducing delays. - Standard Compliance: First eTMF system built using the TMF Reference Model and the eTMF Exchange Mechanism Standard, promoting interoperability and consistency. - Inspection Readiness: Streamlines inspections by maintaining a well-organized and up-to-date TMF, ensuring compliance with regulatory requirements. - Cloud-Based Solution: Offers a simple, cloud-based platform that integrates with existing systems, reducing the burden of managing multiple portals and enhancing user experience. Primary Value and Problem Solved: LifeSphere eTMF addresses the challenges of outdated clinical information management systems that hinder collaboration and efficiency. By providing a unified, real-time platform for document sharing and management, it eliminates the chaos of multiple applications and archaic IT infrastructures. This leads to improved compliance, reduced risk, and significant time savings for all parties involved in clinical trials.

LifeSphere Regulatory

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LifeSphere Regulatory is a comprehensive, cloud-based platform designed to streamline regulatory information management for life sciences organizations. By integrating data, content, and processes into a unified ecosystem, it enhances efficiency, ensures compliance with global regulations, and fosters collaboration across departments. Key Features and Functionality: - Regulatory Information Management (RIM: Offers robust capabilities for product information management, regulatory planning, tracking, and data management, increasing data quality and global oversight. - Product Compliance: Manages medicinal product data submissions throughout submission, post-submission, and post-approval stages in accordance with Identification of Medicinal Products (IDMP requirements. - Document Management: Provides a centralized content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions. - Submission Management & Publishing: Consolidates submission and publishing workflows, simplifying the creation, compilation, and publication of submissions in various formats. - Labeling: Streamlines end-to-end labeling change management and compliance tracking workflows, driving greater efficiency and consistency. - Regulatory Analytics: Utilizes preconfigured dashboards and reports to address common regulatory tracking, reporting, and analytical needs. Primary Value and User Solutions: LifeSphere Regulatory addresses the challenges of managing complex regulatory processes by providing an intuitive and flexible suite focused on risk reduction, collaboration, and efficiency. Its modern cloud architecture ensures compliance with evolving regulations through regular updates and future-proof features. By integrating with other LifeSphere systems, such as Safety and Quality, it offers a holistic approach to regulatory affairs management, enabling organizations to accelerate approvals, reduce risks, and streamline collaboration across departments.