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Japan Medical Association Center for Clinical Trials Adopts Fuji Xerox Document Management Solution

Thursday 04. July 2013 - Ensures Document Authenticity of Clinical Trial Documents, Beginning in Spring 2014

To ensure the authenticity of clinical trial documents, Fuji Xerox Co., Ltd.’s solution (hereinafter, the Solution) utilizing its document management software Apeos PEMaster Evidence ManagerNote1 has been adopted by the Japan Medical Association Center for Clinical Trials (hereinafter, JMACCT) and will be incorporated in the cloud-based Clinical Trial Document Support System (see figure) operated by JMACCT. Operation will begin in spring 2014.
Equipped with this Solution, the Clinical Trial Document Support System will become Japan’s first system that can perform a series of clinical trial-related tasks in the cloud; from information input and sharing between users to storage of documents and preparation for clinical trial audits.
JMACCT is promoting the development of a platform for clinical trials in Japan as part of the Large Scale Clinical Trial Network Project, a clinical trial promotion program subsidized by the Ministry of Health, Labour and Welfare of Japan. Launched in 2010, the Clinical Trial Document Support System offers a free-of-charge cloud service that is available to medical institutions, pharmaceutical and medical equipment companies, Contract Research Organizations (CRO)Note2, Site Management Organizations (SMO)Note3, Institutional Review Boards (IRB) and other bodies involved in clinical trials. To streamline clinical trial paperwork and promote information sharing, this system has provided these bodies with the necessary clinical trial forms and data, and as of June 2013 is being used by more than 330 organizations.
The core software of Fuji Xerox’s clinical trial document solution—Apeos PEMaster Evidence Manager—is designed to comply with regulations of the Pharmaceutical Affairs Act and to ensure record authenticity. Based on user and clinical trial information registered in the Clinical Trial Document Support System, the Solution enables users to automatically or manually create folders to store standard forms for schedule documents, reports on results, letters of consent and requests created in individual clinical trial processes. In addition, these documents can be stored in the system with digital signature and time stamp attached to ensure their authenticity. This Solution complies with the e-record / e-signature guidelines published by the Ministry of Health, Labour and Welfare that establish the requirements for securing the reliability of electronic data, and its reliability is ensured by Computerized System Validation (CSV)Note4.
With this Solution incorporated, the Clinical Trial Document Support System enables users to store original clinical trial documents in the form of electronic files for a long period of time and easily search them without the need to establish an individual document management system at each organization. Offering a more secure usage environment to organizations currently using this system as well as for future users, it is expected to promote information sharing between users and streamline the development of drugs and medical equipment.
“After careful consideration of a solution that can store clinical trial-related documents for a long period of time while ensuring their authenticity, we selected the Solution noting the low cost, stability and long product cycle of Apeos PEMaster Evidence Manager,” said Shuji Wakai, director, JMACCT. “Moreover, we were able to reduce development costs thanks to the Solution’s default function of enabling linkage to the existing functions of the Clinical Trial Document Support System. Working with Fuji Xerox, we will further enhance the functions and quality of the Clinical Trial Document Support System so that we can provide stable support throughout the various clinical trial phases.”
Capitalizing on its strengths in document-related technologies and know-how, Fuji Xerox provides solutions and services that contribute to medical safety and quality improvement, including an integrated medical record management solution for hospitals, document services for pharmaceutical companies and system validation support. Moreover, by assisting communication between users in the Clinical Trial Document Support System through this Solution, Fuji Xerox will contribute to acceleration of the development of drugs and medical equipment and improving their quality.
Both this Solution and the Clinical Trial Document Support System will be presented in the Fuji Xerox booth at the International Modern Hospital Show 2013 to be held from July 17 at Tokyo Big Sight.