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Cloud-based document management system 'Agatha eTMF'

Cloud-based document management system 'Agatha eTMF'

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.

  • File Management

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[On-Demand Webinar] Response to the Revision of Electromagnetic SOP

[On-Demand Webinar] Response to the Revision of Electromagnetic SOP

[Video Explanation! 2024 Edition] Response to the Revision of Electromagnetic SOP - Advancing with Agatha's Latest Process -

For medical institutions and pharmaceutical companies, the proper management and swift operation of clinical trial-related documents are becoming increasingly important. The "Standard Operating Procedures for the Electronic Handling of Clinical Trial-Related Documents (2024 Edition)," which revises the 2015 version of the standard operating procedures for the electronicization of clinical trial processes to adapt to the current clinical trial environment and assumes the use of a clinical trial cloud system, has been newly issued by the Pharmaceutical Manufacturers Association. In this webinar, we will introduce Agasa Corporation's response to the revision of the standard operating procedures. *You can watch the video of the webinar held on June 25, 2024.

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Clinical Trial Document Management System_Case Study at Okinawa Prefectural Chubu Hospital

Clinical Trial Document Management System_Case Study at Okinawa Prefectural Chubu Hospital

Introducing examples of electronic and digitized clinical trial documents using cloud services!

We would like to introduce the case study of the implementation of "Agatha Facility Document Storage + IRB" at Okinawa Prefectural Chubu Hospital, a core hospital with 550 beds. One of the issues with clinical trial management at this hospital was the difficulty of visits by Clinical Research Associates (CRA) due to the geographical characteristics of Okinawa. By introducing Agatha and digitizing the process, we were able to improve the efficiency of clinical trial management operations and reduce costs. 【Benefits of Implementation】 ■ Cost reduction ■ Improved operational efficiency ■ Off-site SDV ■ Reduced storage space ■ Reduced burden on CRA personnel ■ Enhanced quality control *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System - Case Study at Japan Medif Physics Co., Ltd.

Clinical Trial Document Management System - Case Study at Japan Medif Physics Co., Ltd.

A case of streamlining the new drug development application process through document sharing!

We would like to introduce a case study of the "Agatha application document" implemented by Japan Medical Physics Co., Ltd., a company with a long history in the field of nuclear medicine. The company was previously creating and managing CTDs on a file server, but issues arose regarding security and the difficulty in determining whether the approved electronic documents were being used correctly in the eCTD compilation. After implementation, they were able to create CTDs while ensuring authenticity, readability, and preservation in accordance with the ER/ES guidelines. 【Key Points of Adoption】 - The entire process of document creation, review, and approval can be conducted within the system, making it clear which version has been approved. - Ability to create PDFs compatible with eCTD format. - It is a cloud service and is more cost-effective than other services. *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System: Case Study at Fukuoka City Children's Hospital

Clinical Trial Document Management System: Case Study at Fukuoka City Children's Hospital

Achieved the digitization of essential documents for IRB with Agatha! Reduced paper usage by approximately 74 kg in six months.

We would like to introduce a case study on the implementation of "Agatha Document Storage + IRB" by Fukuoka City Children's Hospital, a highly specialized medical facility. At the hospital, all documents related to clinical trials were created and managed on paper, but it was anticipated that storage space would quickly become insufficient. By changing from document management in the hospital's warehouse to using Agatha for document management, we have received feedback that it has become possible to clarify the costs associated with document management. 【Implementation Effects】 ■ Reduced costs for paper, printing, and mailing ■ Decreased time required for SDV preparation ■ Ability to access materials anytime and anywhere ■ Filing rules have become those of the hospital *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System - Case Study at BeyondSpring Inc.

Clinical Trial Document Management System - Case Study at BeyondSpring Inc.

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.

  • Document and Data Management

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Clinical Trial Document Management System: A Case Study of Nippon Medical School Educational Corporation Research Coordination Center

Clinical Trial Document Management System: A Case Study of Nippon Medical School Educational Corporation Research Coordination Center

The realization of hospitals' SDGs through the platformization of clinical trial operations and the standardization of business processes!

We would like to introduce a case study of the implementation of "Agatha Facility Document Storage + IRB" at the Japan Medical University Research Coordination Center. The center has been operating for several years now and is currently identifying issues and considering improvements to further accelerate digital transformation (DX) in clinical trials. As part of their Quality Management System (QMS), they are working on creating rules that ensure there are no omissions in the final deliverables, including working files that arise in the site's unique intermediate state. 【Highlights】 - To achieve true DX, it is important to consider the introduction of Agatha alongside the standardization of operations. - The centralization of the IRB has streamlined the personnel in the IRB office and shortened the lead time for clinical trials. - The hospital aims for SDGs by fairly passing on clinical trial costs to medical institutions and returning that to patient care. *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System_Case Study in a Biotechnology Company

Clinical Trial Document Management System_Case Study in a Biotechnology Company

Introducing Agatha to digitize clinical trial-related documents! A smooth implementation project from launch to full operation.

We would like to introduce a case study of the implementation of "Agatha eTMF" by Enlivex Therapeutics, a biotechnology company engaged in clinical development. The company previously managed clinical trial-related documents on paper, but with the launch of new clinical trials, they embarked on digitization. The implementation project began in late May 2020, and just five weeks later, on July 1, it went live. The setup and configuration of the test environment and the production environment were completed during this period. [Reasons for Selection] - It aligns with the current classification structure, and empty folders for essential documents are automatically created when registering facilities. - The TMF structure can be finely configured by country, facility, and project. - QC check functionality is implemented. *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System: Case Study at Osaka Metropolitan University Hospital

Clinical Trial Document Management System: Case Study at Osaka Metropolitan University Hospital

We won't settle for just a document sharing tool! Expectations for a system migration to Agatha in a short period and for improved operational efficiency.

We would like to introduce the case study of the implementation of "Agatha Facility Document Storage + IRB" at Osaka Metropolitan University Hospital. The hospital was looking for a successor service following the discontinuation of their clinical trial support system, "Cut Do Square." After implementation, we have received feedback that it is convenient to be able to output the email addresses of registered requesters in bulk for each workspace. [Key Factors for Adoption] - Meets the specifications required for clinical trial document management while providing services at a low cost - User-friendly UI that is simple and intuitive to operate - Information exchange within the user community - Prompt support response *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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[Case Study Collection] Clinical Trial Document Management System "Agatha"

[Case Study Collection] Clinical Trial Document Management System "Agatha"

The electronicization of GxP documents in pharmaceutical companies and the expansion of electronic exchanges between medical institutions and pharmaceutical companies!

In this document, we summarize and introduce case studies of Agatha Inc.'s cloud-based document management system "Agatha." We present five case studies, including responses to FDA inspections, transitions from foreign systems, and a project to centralize events across approximately 10 factories. Each case includes the challenges faced and comments from users. This is a valuable resource, so please take a moment to read it. 【Featured Case Studies】 ■ Response to FDA inspections using Agatha ■ Implementation in both the medical device and pharmaceutical sectors ■ Case studies of transitions from foreign systems ■ Centralization project for events across approximately 10 factories ■ Implementation of Agatha QMS and SOP both domestically and internationally *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Methods for Advancing Electromagnetic Records of IRB: A Case Study of Fukui University Hospital

Methods for Advancing Electromagnetic Records of IRB: A Case Study of Fukui University Hospital

How to transition to sustainable operations following the abolition of the cut-do-square! Introducing methods to promote electronic records of the IRB through use cases.

To Fukui University Hospital, we would like to introduce the case of implementing the document management system "Agatha" following the discontinuation of Cut Do Square. At the hospital, actual document storage was conducted in paper format, which posed challenges such as taking up space within the facility and the effort required to search for documents. To digitize all aspects of IRB operations from procedures to document storage, we began the implementation of this system. The rapid progress made in preparations for the implementation became a decisive factor in choosing the system. [Case Overview] ■Challenges - Document storage in paper format takes up space within the facility and complicates the search for materials. - The effort involved in printing and mailing paper documents was also viewed as a problem. ■Background of Implementation - The presence of a community for information exchange, where questions could be answered and examples from other facilities could be shared, also supported the implementation. *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Cloud-based document management system "Agatha Basic"

Cloud-based document management system "Agatha Basic"

For companies looking to achieve paperless solutions in line with Part 11 compliance! We enable a small start in both cost and scale.

Agatha Basic is a document management cloud service equipped with basic functions for sharing, storing, and managing documents related to clinical trials and research. It is a high-security, highly reliable system compliant with ER/ES guidelines, FDA regulations, and CFR 21 Part 11. It is simple and easy to use, and during implementation, dedicated consultants provide support, along with ongoing assistance from a help center, ensuring that even first-time users can use the document management system with confidence. <Recommended for> ● Those who are managing documents on paper and want to reduce the enormous workload and costs involved. ● Those who want to manage and share documents in compliance with ER/ES and CFR Part 11. ● Those who wish to achieve seamless information sharing and management beyond location and time constraints, whether on the go or across multiple facilities. ● Those who find file management complicated due to not knowing the latest version or accidentally overwriting files. ● Those troubled by the rising costs, complexity, and operation of existing systems. ● Those considering the latest security measures and disaster/pandemic response (BCP/BCM). *For more details, please refer to the PDF materials or feel free to contact us.

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[On-Demand Webinar] Data Integrity Compliance Seminar

[On-Demand Webinar] Data Integrity Compliance Seminar

Mr. Murayama from eCompliance Co., Ltd. will be speaking! Seminar on Data Integrity in relation to deviations, CAPA, change management, etc.

You can watch the video of the webinar held on May 17, 2024. Seminar on Data Integrity in Deviation, CAPA, and Change Management ~ Event management to comply with regulatory requirements in Japan, the U.S., and Europe ~ As data integrity measures progress, the pharmaceutical and medical device industries are required to manage a multitude of event data, including deviation management, change management, CAPA, nonconformance management, training, and audits. There are limitations to managing data based on human input, such as with Word and Excel, and we often hear about situations where related documents are stored separately due to paper management, making it impossible to manage them in a linked manner. Event data should inherently be interconnected, and it is crucial to have quick access to related data. So, how can we effectively manage these often complex data sets? In this seminar, we will clearly explain the principles of event management and how to ensure data integrity.

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Clinical Trial Document Management System_Case Study at the Japan Complement Society

Clinical Trial Document Management System_Case Study at the Japan Complement Society

Introducing a case study on streamlining document sharing and management in clinical research!

We would like to introduce a case study of the implementation of "Agatha Basic" by the Japan Complement Society. The society was previously exchanging test data and case reports via email, but this method was very cumbersome, required the hassle of password protection, and posed a risk of misdelivery. After the implementation, it became possible to simply enter progress into Excel and save it, allowing stakeholders to constantly share new information and retrieve past information when needed. 【Key Factors for Implementation】 ■ Usable on MAC ■ Easy to read and use ■ Easy to start *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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Clinical Trial Document Management System_Example at Mediscience Planning Co., Ltd.

Clinical Trial Document Management System_Example at Mediscience Planning Co., Ltd.

Introducing a case study of implementing eTMF in CRO at a low cost!

We would like to introduce a case study of the implementation of "Agatha eTMF" by Mediscience Planning Co., Ltd., a company with a rich history in the CRO industry. The company has started to consider the implementation of eTMF due to an increasing number of requests from global clients wanting to utilize it. After the implementation, Agatha is being used not only as a tool to manage essential documents for the clinical trials they undertake but also to manage internal SOPs, thereby expanding its use as their document management platform. 【Benefits of Implementation】 ■ The greatest advantage is ease of use ■ Flexible clinical trial document list ■ Compliance with high security requirements in the healthcare and life sciences fields ■ Risk-based Monitoring (RBM) *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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