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Agatha Corporation is set to release a new version of its cloud service 'Agatha CTMS', which is easy to use even in advanced clinical trials. This service is designed to meet Japanese regulatory requirements while also being capable of supporting global trials, featuring both "simplicity" and "flexibility." It allows for the creation and management of monitoring reports for each trial via web forms, as well as the registration and management of issues, achieving centralized document management and visualization of information with a simple UI tailored to user needs. [Development Concept] ■ Triple A Project - Advancing (Evolution of Management) - Accelerating (Acceleration of Clinical Trials) - Achieving (For the Patients) *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

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

We would like to introduce the case study of the implementation of "Agatha Facility Document Storage + IRB" at the Independent Administrative Institution National Hospital Organization Nagoya Medical Center. Due to the discontinuation of the clinical trial support system "Cut Do Square" that was previously in use, the hospital needed to contract a successor system as quickly as possible, begin actual operations, and start preparations such as examining operational methods and creating SOPs. After implementation, we received feedback that the system offers high flexibility and allows for customization of display methods to fit the hospital's operational practices. 【Key Factors for Adoption】 - The time from contract to start of use is extremely fast. - A free trial plan is available before contracting, allowing users to confirm the actual operation feel. - There is ample support for system operation and management. *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

We would like to introduce a case study on the implementation of "SOP management and educational records" at the independent non-profit academic research organization Intergroupe Francophone de Cancérologie Thoracique, which specializes in lung cancer. This organization faced challenges as document management became increasingly difficult with the growing number of documents, and the paper-based manual document management could not keep up. After the implementation, we received feedback that version control automation and review and approval management were systematized, allowing for quick access to necessary documents. [Case Overview] ■ Challenges - Unable to manage documents effectively with paper-based manual processes ■ Effects - Reduced the risk of compliance violations due to human error - Highly rated internally for being efficient and user-friendly - Monitoring of educational implementation status has also become simple and efficient *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

We would like to introduce a case study on the implementation of "Agatha Facility Document Storage + IRB" at Triad Japan Co., Ltd., which conducts operations related to CRC, clinical trials, and IRB. The company found it challenging to continue securing storage space for essential documents in a limited area as the volume of materials increased. After the implementation, the piles of cardboard boxes disappeared, and the office no longer felt cramped, resulting in a cleaner appearance, according to feedback received. 【Case Overview】 ■Challenges - Shredding of paper review materials collected from committee members after IRB meetings each month - Costs associated with paper and printing, document preparation, distribution, mailing, and disposal of paper ■Effects - Easier sharing of essential documents with clients - Significant reduction in time spent on storing paper materials and a substantial decrease in space required *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

We would like to introduce a case study on the implementation of "SOP Management and Training Records" and "Agatha QMS" at Riverfield Inc., which develops medical robots. At the company, operations were conducted using printed documents created in Word and an analog procedure of circulating approvals on paper. After the implementation, they have achieved greater efficiency and accuracy in their operations, and they have reported that urgent approvals can now be obtained in a very short time. [Utilized Operations] ■ Agatha SOP - Review and approval workflow for newly created or revised documents such as various regulations and forms - Implementation of training (Read & Review, confirmation tests) - Viewing of documents such as regulations and forms, and investigation of revision history ■ Agatha QMS - Management of nonconformities, complaint handling, and CAPA management in the QMS for medical devices *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

We would like to introduce a case study on the implementation of "Agatha eTMF" by the medical device manufacturer Optos, Inc. Initially, the company managed clinical trial-related documents (TMF) using a different system, but felt that the visibility and tracking features essential for managing clinical trial documents were insufficient. The deciding factor for the implementation was the ability to customize the system, as well as the option to provide it on a subscription model for each site and trial. 【Essential Requirements for Implementation】 - The ability to store all documents in a single location that meets various document storage requirements. - A structured format that is easy to understand and usable by anyone. - Secure cloud storage and backup. - The ability to configure according to medical device requirements. *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

We would like to introduce a case study of "Agatha eTMF" by InCarda Therapeutics, which conducts clinical development in California, USA. The company had outsourced TMF management, but it became increasingly complicated, and it was clear that a more rational and cost-effective operational method was needed. The implementation project was completed in about six weeks and included various configuration changes, document classification definitions, the addition of new fields such as responsible persons and affiliations through an automatic naming function, and user training. [Case Overview] ■ Challenges - Difficulty in document verification, requiring manual tracking for quality checks - Need to directly check TMF documents whenever an issue arose ■ Benefits - Ability to configure the system according to operational methods - Automatic verification of all documents within the system without relying on manual processes *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

We would like to introduce a case study on the implementation of "Agatha eTMF" at DZS Clinical Services, a full-service CRO. The company faced challenges related to document quality management and collaboration among various stakeholders, including facilities, sponsors, different personnel, and management. After the implementation, we received feedback that the initiation of trials, registration of facilities and users, and document registration have become significantly more efficient than before. 【Case Overview】 ■Challenges - Managing the process of quality checks for clinical trial-related documents - Verifying that all necessary documents are complete ■Benefits - Document naming and management are consistent with standard methods, making it user-friendly for CRAs - Quality management of documents can be conducted within the system, allowing for easy report generation *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

We would like to introduce a case study on the implementation of "Agatha QMS" by Mablink Bioscience, a biotechnology company based in France. The company wanted to manage clinical trials from the beginning with the appropriate methods, processes, and systems. By using Agatha, they can obtain the necessary data from documents and forms, allowing them to smoothly advance through each stage of the trial. [Case Overview] ■Challenges - There was no way to register and manage documents for each trial phase. - It was difficult to find files. ■Benefits - All trial-related documents and administrative paperwork can be easily managed. - They can grant access to VCs for information provision during fundraising. *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

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

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

We would like to introduce a case study on the implementation of "Agatha Basic" by the Tohoku University Hospital Clinical Trial Data Center, which supports data management for clinical research conducted by Tohoku University. At this center, managing documents on a file server involved significant operational burdens, such as strictly adhering to file naming and storage rules, and converting important documents into paper versions. After the implementation, we received feedback that document sharing could be done smoothly without being constrained by location. 【Case Overview】 ■ How Agatha is Used - Management of QMS documents and SOPs at the data center - Management of research project documents ■ Benefits of Implementation - Utilized system functions such as version control, tamper prevention, and approval records in operations - Became able to recognize and manage the benefits and risks of document management and systems *For more details, please download the PDF or feel free to contact us.

• Document and Data Management

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

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

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

Agatha Corporation will hold a webinar titled "Data Integrity: Key Points and Countermeasures for FDA Inspections - The Quality Management System Expected by the FDA" online. In this webinar, we will provide detailed explanations of DI violation cases pointed out during FDA GMP inspections, fundamental solutions to DI issues, the establishment of a quality management system, and essential items for supplier audits. Furthermore, in the second part, we will introduce our Agatha solutions and validation support services related to the webinar theme. [Event Overview] ■ Date: February 7, 2025 (Friday) 14:00 - 15:30 ■ Registration Deadline: February 6, 2025 (Thursday) 16:00 ■ Format: Webinar (Broadcast via Zoom) ■ Participation Fee: Free *For more details, please download the PDF or feel free to contact us.

• Technical Seminar

You can watch the video of the webinar held on August 9, 2023. In addition to introducing the Agatha solutions deployed in the GCP area, we will present case studies from companies that have actually implemented them, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also introduce examples of utilizing TMF Metrix evaluation using reporting tools. We encourage you to participate and hope it will help you in solving your company's challenges.

• others

You can watch the video of the webinar held on February 14, 2024. In addition to introducing the Agatha solution deployed in the GCP area, we will showcase case studies from companies that have actually implemented it, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also present examples of using the TMF Metrix evaluation with reporting tools. We encourage you to participate and hope it will help you address your company's challenges.

• others

You can watch the video of the webinar held in April 2024. In addition to introducing the Agatha solutions deployed in the GCP area, we will present case studies from companies that have actually implemented them, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also introduce examples of utilizing TMF Metrix evaluation using reporting tools. We encourage you to participate and hope it will help you address your company's challenges.

• others

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.

• others

You can watch the video of the webinar held on June 19, 2024. In addition to introducing the Agatha solution deployed in the GCP area, we will present case studies from companies that have actually implemented it, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also introduce examples of utilizing the TMF Metrix evaluation using reporting tools. We encourage you to participate and hope it will help you address your company's challenges.

• others

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.

• others

Webinar video distribution application here: https://go.2.agathalife.com/l/1014252/2024-07-11/314jj 【Agatha SOP】 A cloud service that centrally manages the original documents of Standard Operating Procedures (SOP) and training records. A highly reliable and secure system compliant with the Ministry of Health, Labour and Welfare's ER/ES guidelines and FDA 21 CFR Part 11. It allows for the registration and automatic version management of SOPs, reviews and approvals, audit trails, expiration reminders, and sharing of the latest SOP versions across multiple devices. It supports proper change management to ensure the reliability of SOPs. Additionally, it manages training records related to SOPs, significantly reducing the burden on personnel and enhancing productivity. <Recommended for> ● Those whose management of Standard Operating Procedures (SOP) is manual, incurring time and costs ● Those who want to detect SOP expiration in advance ● Those who want to share the latest or replacement SOPs immediately ● Those who want to reduce the burden on the person in charge by informing each group ● Those who want to have an overview of individual training participation status for each SOP ● Those who want to implement e-learning (quizzes and tests) for training.

• Document and Data Management

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

Agatha QMS is a document and quality management cloud service that enables the management of quality processes (such as CAPA, deviations, complaint management, audit management, change management, and other quality event information) necessary in the pharmaceutical and medical device industries. It is a highly secure and reliable system that complies with the Ministry of Health, Labour and Welfare's ER/ES guidelines and FDA 21 CFR Part 11 requirements, supporting quality management for GxP-related operations that require strict control. Agatha revolutionarily integrates process management and document management, promoting user adoption with simple and easy-to-use operability. By linking with Agatha SOP, it achieves further reliability, labor-saving, and efficiency in quality management activities. <Features of Agatha QMS> ● Compliant with various regulations for the pharmaceutical and medical device industries ● Creation of original input screens, enabling database integration ● As a cloud service, access to the system is possible by granting licenses to necessary personnel, regardless of internal or external sites ● Support services for CSV (PQ) implementation available *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

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.

• Document and Data Management