Management System×アガサ - List of Manufacturers, Suppliers, Companies and Products

Clinical Trial Document Management System: A Case Study at Tohoku University Hospital Clinical Trial Data Center

A case of enhancing document management in clinical research through tamper prevention and version control!

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.

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Case study of clinical trial document management system in Mablink Bioscience.

Achieve compliance with Agatha! Quality guaranteed, required both medically and in 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.

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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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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.

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.

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 in a Lung Cancer Research Organization

Introducing Agatha SOP to improve document management for quality control and human resource 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.

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Clinical Trial Document Management System: A Case Study at Nagoya Medical Center, National Hospital Organization

Never go back to paper even once! How we overcame the system transition in about two months.

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.

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Document and Data Management

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Management System×アガサ - List of Manufacturers, Suppliers, Companies and Products

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