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