TOKYO, July 17, 2012 — Fuji Xerox Co., Ltd. has begun providing a document management solution for streamlining clinical trial work carried out at hospitals to gain approval under the Pharmaceutical Affairs Act as part of a drug development process. The company offers the solution to hospitals that carry out clinical trials and to the clinical trial network where joint clinical trials are conducted by a number of hospitals.
Built based on Fuji Xerox's Apeos PEMaster—software that effectively manages electronic and printed records in an integrated manner—this document management solution for clinical trials (hereinafter, this solution) efficiently manages forms, materials, registers, certificates and other various documents that appear during the work process of clinical trials, and allows users to visually check each progress.
When basic information of a certain clinical trial plan is registered, this solution automatically produces a face sheet with a quick response (QR) code with that information encoded. By scanning clinical trial-related documents with a fax or a scanner along with the face sheet, those documents will be stored in the same designated folder. With this solution, all documents that are used or created during each clinical trial process can be appropriately registered to the system and viewed with simple operations. Some examples of such documents may be schedule documents, results created in each clinical trial process, letters of consent, requests, safety reports, and other types of evidence.
Moreover, information encoded in the QR code on the face sheet, as well as handwritten information such as trial subject codes and start/end dates of drug administration, are also automatically listed on to a register of the system and attached to the simultaneously registered documents. This register will enable the users to get a panoramic view of the overall status and easily check if all necessary documents and evidence are ready for the Institutional Review Board (IRB) while confirming progresses and looking for any missed steps from the overall trial process.
By streamlining document management of the entire clinical trial work, Fuji Xerox helps doctors and staff to concentrate on their primary work with less stress from supplementary matters.
This solution will also be provided to the clinical trial network where joint clinical trials are conducted by a number of hospitals. One example is its introduction to the Japanese Pediatric Clinical Trial NetworkNote1, a network specialized in clinical trials of pediatric drugs. The operation has begun in June and a clinical trial document management system mainly around a central bureau is nearly established.
By meeting user needs to build networks or document management systems, Fuji Xerox assists streamlining the clinical trial work. This solution helps centralize work by making a single interface against the central bureau, standardizing documents and processes, sharing information among hospitals, and managing each progress according to case or facility.
Fuji Xerox will contribute to accelerating and improving the quality of drug development by assisting medical institutions in information sharing and communications. Furthermore, as can be observed from the already-offered integrated medical record management solution toward hospitals as well as the document services provided toward pharmaceutical companies, we will provide solutions and services that contribute to medical safety and quality improvement with our strengths in document-related technologies and know-how.
This solution will be presented in the International Modern Hospital Show 2012 to be held from July 18 to 20 at Tokyo Big Sight.