Realized speedy development of new medicines and cost cut through efficient process of ‘clinical trial‘ utilizing IT
Fukuoka University Hospital and Kinki University Hospital introduced SOFTBANK TELECOM‘S clinical trial administration support system using network

April 16, 2007
SOFTBANK TELECOM Corp.

SOFTBANK TELECOM Corp. (head office; Minato-ku, Tokyo, Representative; Masayoshi Son, hereinafter referred to as SOFTBANK TELECOM) announces that it developed and delivered ‘clinical study/clinical trial support solution "Clinical Effort"‘ (hereinafter referred to as Clinical Effort) to Fukuoka University Hospital (Jonan-ku, Fukuoka-shi, Fukuoka, Hospital Director; Tatsuhiko Kawarabayashi) and Kinki University Hospital^*1 (Osakasayama-shi, Osaka, Hospital Director; Hitoshi Shiozaki). Clinical Effort is a medical institution shared (ASP) system using network to shorten process related to clinical trial to develop new medicines and to support more smooth and efficient administration.

"Clinical trial" is a clinical test to be conducted by patients and participants who agreed for cooperation (hereinafter referred to as subject), pharmaceutical companies and medical institutions to confirm ‘efficacy‘ and ‘safety‘ in the course of process of new medicine development. Data obtained through trials will be a base for assessment procedure and evaluation before approval of a new medicine. It normally takes 9 to 17 years for development. It is estimated^* that a pharmaceutical company who requests drug discovery should bear expense of approximately JPY20 billion to JPY30 billion and that new drug development in Japan compared to practice overseas should sustain extremely huge time-lag between investment in development to collection of the investment.

Usually, "clinical trial" administration requires enormous quantity of documents exchange per initiative among the concerned. For confirming contents, it commonly involves physical burden such as an occasion that a pharmaceutical company and subjects need to go to a medical institution bringing documents in hand to meet a doctor in charge. For medical institutions that have established their own system, it is not realistic to develop and expand an additional system to fit into a clinical trial environment involving more than one initiative and concerned institution as there are issues such as compatibility with systems of other institutions and cost. Also, under circumstances of rapid changes of medical regulations it is very difficult to build one‘s own system to flexibly respond to changes.

SOFTBANK TELECOM developed Clinical Effort, an administration support system using network that facilitates work improvement through introduction of common applications usable on network of pharmaceutical companies, with a concept to ‘share‘ while mutually enjoying merits through responding to various changes of clinical trial environment and such, instead of building a system ‘on one‘s own.‘ This service accommodates ‘clinical trial‘ data in a highly-secured data center to allow the concerned institutions to access the data through their Internet line in a highly-secured environment to safely confirm initiatives and manage their progress on a real-time basis.

SOFTBANK TELECOM aims to help improve ‘cost‘ ‘time‘ and ‘quality‘ viewed as an issue for current ‘clinical trials‘ with this service as a shared ASP service that supports institutions with their work improvement by standardizing administration, improving efficiency and realizing smooth implementation of clinical trial process.

Clinical Effort has the following advantages.

1. Information sharing using the Internet/the Web

• "Clinical trial" related institutions will be able to confirm and share contents/progress status of initiatives under application on a real-time basis in their Internet environment on their Web browser.
• Notification e-mail will be sent to the concerned upon information update on the system, which will realize quick communication/sharing of latest information.
• As for reception/management of assessment information, administration work between physically distant institutions will be smoothly and speedily handled to shorten lead time.
• Information sharing will reduce administrative errors and mistakes.

2. Data management with highly-secured measures

• Communication route and communication data are all encrypted that allows exchange of confidential data over a network.
• Access authorization with user authentication ID/PW is available as well as historical management of data registration/deletion by access log management.
• Database is managed at Data Center of SOFTBANK TELECOM around the clock for 365 days and backup of the data is also done as needed.

3. Reduction of operation with ASP type service

• This service is an ASP service using a normal Internet environment that does not require any special facilities for installation. Compared with building a system on one‘s own, initial/operational cost can be suppressed.
• Drafting mandatory documents will become easier with a template function for documents to submit that automatically allocates relative data on the system.

Fukuoka University Hospital, which introduced Clinical Effort, set up Clinical Research Assist Center and proactively tackles "clinical trials." Associate Professor Keita Noda of Clinical Research Assist Center at Fukuoka University Hospital told us the motive of introduction, "We emphasize ‘clinical trials‘ that will bring us medical improvement and make efforts to develop new medicines that will enable us to provide latest treatment to patients who seek a new method of treatment. A support system using network such as Clinical Effort offers medical institutions without dedicated IT function like our hospital introduction of the system with ease and facilitates outsourcing to a network communication company with rich operational expertise. That is a great advantage for us." The hospital plans to increase the number of pharmaceutical companies to share clinical trial data gradually and aims for full-fledged introduction in May 2007.

Health, Labour and Welfare Ministry has set up a ‘study group to create next version of clinical trial vitalization plan‘ in June 2006 in order to vitalize ‘clinicaltrials‘ and drawn ‘FY2007 5-year plan.‘ For drafting, the study group listed ‘current status of documentation, procedures and IT of clinical trials toward efficient clinical trials‘ among items under study for clinical trial status. The result of the study reports ‘efficiency of clinical trial administration is a matter to directly influence cost of clinical trials.‘ In response to this, the action plan for the 5-year plan implementation states to ‘further promote efficiency through clarifying roles and responsibilities of medical institutions and companies, standardizing documentation for clinical trials and use of IT for clinical data in order to accelerate the speed of clinical trials and to cut cost.‘ ‘Efficiency of clinical trials‘ is included in the list of items.^**

SOFTBANK TELECOM will continue to promote Clinical Effort mainly to hospitals that make proactive efforts in clinical trials, will also create services with state-of-the-art technologies using network and will continue to provide optimal ICT solution service to solve customers‘ business challenges and to support customers‘ business.

Please refer to the appendix for service illustration of clinical study/clinical trial support solution ‘Clinical Effort.‘

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• The information is true and accurate at the time of publication.
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