Easily and quickly create and customize an environment tailored for exams! Create, share, and store essential documents and clinical trial-related documents on a project basis.
Agatha eTMF is a document management cloud service designed for the creation, sharing, and storage of essential clinical trial documents and trial-related documents on a project basis. To manage hundreds of types of documents, it has established an industry-standard folder and document structure, allowing for easy and speedy environment setup. It dramatically improves efficiency and reduces labor while ensuring reliability for all operations related to clinical trial documents among sponsors, implementing medical institutions, and contractors (such as document sharing, editing, printing, sending, storage, and monitoring). Customers can choose a structure tailored to their trials. <Features of Agatha eTMF> ● Complies with regulatory requirements and enables electronic original documents ● Pre-set industry-standard folder and document structure for easy and speedy environment creation ● Templates for trial-specific structures with flexible customization options ● Automatic document distribution to "facilities," with a simple and user-friendly UI ● Unprecedented low pricing ● Supports Japanese and English *For more details, please refer to the PDF materials or feel free to contact us.
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▼Recommended for those who: ● Want to reduce and streamline the enormous workload and costs associated with paper management, and are interested in trying eTMF for the next trial. ● Want to manage and share documents in compliance with ER/ES and CFR Part 11. ● Want seamless information sharing and management that transcends location and time constraints, especially for remote work and multi-site operations. ● Are struggling with the cost inflation, complexity, and operation of existing systems. ● Are considering improving quality management systems for monitoring efficiency and detecting high-risk processes through central monitoring. ● Are looking into the latest security measures and disaster/pandemic response (BCP/BCM). ▼Features (excerpt) ● User and access rights management ● Flexible search (fuzzy search, attribute search, etc.) ● Document registration, viewing, editing, and sharing ● Management of document types and metadata ● PDF conversion compliant with eCTD requirements ● Workflow (review, approval) ● Audit trail ● Automatic version control ● Compliance with ER/ES guidelines and FDA CFR 21 Part 11 *For more details, please refer to the PDF materials or feel free to contact us.
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For more details, please refer to the PDF document or feel free to contact us.
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Our company provides a cloud service for creating, sharing, and storing documents related to clinical trials and clinical research on a project basis for medical institutions, pharmaceutical companies, medical device companies, CROs, SMOs, clinical testing companies, and more. In addition to offering systems specialized for the medical and life sciences industries, we provide comprehensive support from implementation to operation by staff with expertise in the medical field. Please feel free to contact us if you have any inquiries.