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Clinical trial document management system Product List

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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.

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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.

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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.

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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.

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Clinical Trial Document Management System_Case Study in a Biopharmaceutical Company

Clinical Trial Document Management System_Case Study in a Biopharmaceutical Company

Agatha achieves in-house production with eTMF! The system can be configured according to operational methods.

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.

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Clinical Trial Document Management System - Case Study at Optos, Inc.

Clinical Trial Document Management System - Case Study at Optos, Inc.

Agatha improves clinical trial business processes with eTMF and remote monitoring!

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.

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

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

Cost reduction and efficiency improvement by Agatha IRB! Promoting the creation of remote environments through the digitization of operations.

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.

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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.

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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.

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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.

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Clinical Trial Document Management System_CRO (Contract Research Organization) Case Study

Clinical Trial Document Management System_CRO (Contract Research Organization) Case Study

Agatha enhances its services as a CRO with eTMF! Improving daily TMF 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.

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