Introducing Agatha for TMF and SOP management to launch new drugs! Operating the Agatha system in the United States and China.
We would like to introduce the case study of "SOP Management and Training Records" and "Agatha eTMF" at the biotechnology company BeyondSpring Inc. When considering future plans in light of the NDA application, the company realized that paper-based SOP management had its limitations and wanted to keep records of operations electronically. After implementation, various tasks are recorded with audit trails, and notifications are sent at each stage. A significant point is that the system provides assurance that employees are consistently adhering to the correct procedures. [Case Overview] ■Challenges - Document management spans multiple vendors, making it difficult to locate documents - Desire to implement e-training ■Benefits - Utilizing Agatha eTMF as a repository for clinical trial-related documents - Ability to view metrics on the progress of training within the department *For more details, please download the PDF 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.