Supports global clinical trial regulations, helps reduce risk and development costs
Tokyo, July 12, 2012 - (JCN Newswire) - Fujitsu today announced the availability, beginning in Japan and the US in September, of an enhanced lineup of its tsClinical solution services for clinical drug development. The tsClinical service enables pharmaceutical companies to optimize the entire drug development process, from Clinical development (clinical trials) up through post-marketing, and to improve the quality,cost and delivery of drug development.
Two new products have been added to the lineup: tsClinical DDworks21 Global, which provides worldwide support for the push toward globally harmonized clinical trial practice guidelines, and tsClinical X-Management, which helps to reduce costs associated with clinical trials and speeds up development times. As a result, users will be able to ensure quality standards and compliance in their clinical trials on a global scale.
In addition, by switching from conventional package-based subscription billing to a monthly usage-based pricing model, the new lineup enables customers to utilize the services applicable to the progress of their clinical development on an as-needed basis. Furthermore, for drug development requiring extended periods of time, tsClinical's cloud-based technology makes it possible to accommodate regulatory changes that occur throughout the course of development and to support the latest technologies, thereby enabling easy utilization of the services.
Until now, each country throughout the world has maintained different Good Clinical Practices (GCP) and digitalization regulations for pharmaceutical companies in the execution of clinical trials. Recently, however, there has been a push by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and other organizations to globally harmonize these regulations in Japan, the United States and Europe, as well as in BRICS countries. This, in turn, will prevent unnecessary repetition of clinical trials by pharmaceutical companies while at the same time streamlining the drug development and approval process.
In recent years, clinical trials have increasingly been outsourced to Contact Research Organizations (CRO), and it is often the case for clinical trials in Asia, Europe and the US that separate CROs are contracted for each country. This makes it difficult for pharmaceutical companies to keep track of information pertaining to the status of trials, such as data on the trial progress, regulatory compliance, and problems encountered during the trial. Moreover, because a host of different parties are involved in a trial - including pharmaceutical companies, doctors, and CROs - and due to the decentralization of ICT systems involved in the trial, data overlap frequently occurs in a variety of contexts.
Given the considerable time requirements inherent to drug development, shortening lead times and cutting costs are very high priorities. At the same time, it is also crucial to employ an environment that is able to accommodate the latest services that quickly support regulatory changes occurring throughout the course of development.
With years of experience in delivering total solutions for business processes in the pharmaceutical industry, ranging from drug discovery to post-marketing, Fujitsu holds the top market share in Japan for such solutions and has contributed to the formulation of standards in Japan's pharmaceutical industry. Offered as a solution that leverages Fujitsu's track record, tsClinical helps customers in the increasingly globalized pharmaceutical industry to reduce risk and mounting development costs.
Service Features
1. tsClinical DDworks21 Global: Reduces global clinical trial risk while ensuring uniform quality standards across different regions
By bringing visibility to information pertaining to the status of clinical trials, such as data on the trial progress, regulatory compliance, and problems encountered during the trial, tsClinical DDworks21 Global aids in improving the efficiency of on-site operations and preventing reporting leaks and errors in application procedures, while also ensuring higher quality standards and smoother administrative operations for clinical trials worldwide. These features serve to eliminate information gaps between pharmaceutical companies and CROs, such as times when companies have difficulty receiving reports from a CRO in a timely manner, in addition to preventing risk factors, such as GCP violations and development delays.
2. tsClinical X-Management: Shortens clinical trial lead times and cuts costs
tsClinical X-Management coordinates data between the different systems employed in clinical trials conducted at various locations. By storing data in XML format, the system can deliver an environment that is uniformly accessible by various stakeholders. Seeing as there are many different people involved in the development of a drug, challenges often arise in the form of overlapping data, development delays resulting from non-uniform data formats, and increased costs due to unnecessary repetition of clinical trials. In order to mitigate these challenges, the system enables an across-the-board optimization of clinical trial operations, as well as large-scale improvements in QCD (quality, cost, delivery).
3. Employs a monthly usage-based pricing model that delivers constantly updated services
By employing monthly usage-based pricing that varies depending on the number of clinical trials being performed and the number of different connected systems, fees are commensurate with the size of the project at hand. As a result, tsClinical is accessible even for small-scale operations. The system can also be expanded or reduced as needed to accommodate different numbers of clinical trials. Moreover, new services can always be provided to support regulatory and other changes, and data for more long-term projects can be stored at a low cost.
Sales Target
Apart from Japan and the US, Fujitsu plans to expand sales to countries in Europe and Asia, with a target of generating 5 billion yen in total sales by 2015.
Tokyo, July 12, 2012 - (JCN Newswire) - Fujitsu today announced the availability, beginning in Japan and the US in September, of an enhanced lineup of its tsClinical solution services for clinical drug development. The tsClinical service enables pharmaceutical companies to optimize the entire drug development process, from Clinical development (clinical trials) up through post-marketing, and to improve the quality,cost and delivery of drug development.
Two new products have been added to the lineup: tsClinical DDworks21 Global, which provides worldwide support for the push toward globally harmonized clinical trial practice guidelines, and tsClinical X-Management, which helps to reduce costs associated with clinical trials and speeds up development times. As a result, users will be able to ensure quality standards and compliance in their clinical trials on a global scale.
In addition, by switching from conventional package-based subscription billing to a monthly usage-based pricing model, the new lineup enables customers to utilize the services applicable to the progress of their clinical development on an as-needed basis. Furthermore, for drug development requiring extended periods of time, tsClinical's cloud-based technology makes it possible to accommodate regulatory changes that occur throughout the course of development and to support the latest technologies, thereby enabling easy utilization of the services.
Until now, each country throughout the world has maintained different Good Clinical Practices (GCP) and digitalization regulations for pharmaceutical companies in the execution of clinical trials. Recently, however, there has been a push by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and other organizations to globally harmonize these regulations in Japan, the United States and Europe, as well as in BRICS countries. This, in turn, will prevent unnecessary repetition of clinical trials by pharmaceutical companies while at the same time streamlining the drug development and approval process.
In recent years, clinical trials have increasingly been outsourced to Contact Research Organizations (CRO), and it is often the case for clinical trials in Asia, Europe and the US that separate CROs are contracted for each country. This makes it difficult for pharmaceutical companies to keep track of information pertaining to the status of trials, such as data on the trial progress, regulatory compliance, and problems encountered during the trial. Moreover, because a host of different parties are involved in a trial - including pharmaceutical companies, doctors, and CROs - and due to the decentralization of ICT systems involved in the trial, data overlap frequently occurs in a variety of contexts.
Given the considerable time requirements inherent to drug development, shortening lead times and cutting costs are very high priorities. At the same time, it is also crucial to employ an environment that is able to accommodate the latest services that quickly support regulatory changes occurring throughout the course of development.
With years of experience in delivering total solutions for business processes in the pharmaceutical industry, ranging from drug discovery to post-marketing, Fujitsu holds the top market share in Japan for such solutions and has contributed to the formulation of standards in Japan's pharmaceutical industry. Offered as a solution that leverages Fujitsu's track record, tsClinical helps customers in the increasingly globalized pharmaceutical industry to reduce risk and mounting development costs.
Service Features
1. tsClinical DDworks21 Global: Reduces global clinical trial risk while ensuring uniform quality standards across different regions
By bringing visibility to information pertaining to the status of clinical trials, such as data on the trial progress, regulatory compliance, and problems encountered during the trial, tsClinical DDworks21 Global aids in improving the efficiency of on-site operations and preventing reporting leaks and errors in application procedures, while also ensuring higher quality standards and smoother administrative operations for clinical trials worldwide. These features serve to eliminate information gaps between pharmaceutical companies and CROs, such as times when companies have difficulty receiving reports from a CRO in a timely manner, in addition to preventing risk factors, such as GCP violations and development delays.
2. tsClinical X-Management: Shortens clinical trial lead times and cuts costs
tsClinical X-Management coordinates data between the different systems employed in clinical trials conducted at various locations. By storing data in XML format, the system can deliver an environment that is uniformly accessible by various stakeholders. Seeing as there are many different people involved in the development of a drug, challenges often arise in the form of overlapping data, development delays resulting from non-uniform data formats, and increased costs due to unnecessary repetition of clinical trials. In order to mitigate these challenges, the system enables an across-the-board optimization of clinical trial operations, as well as large-scale improvements in QCD (quality, cost, delivery).
3. Employs a monthly usage-based pricing model that delivers constantly updated services
By employing monthly usage-based pricing that varies depending on the number of clinical trials being performed and the number of different connected systems, fees are commensurate with the size of the project at hand. As a result, tsClinical is accessible even for small-scale operations. The system can also be expanded or reduced as needed to accommodate different numbers of clinical trials. Moreover, new services can always be provided to support regulatory and other changes, and data for more long-term projects can be stored at a low cost.
Sales Target
Apart from Japan and the US, Fujitsu plans to expand sales to countries in Europe and Asia, with a target of generating 5 billion yen in total sales by 2015.
Pricing and Availability Product Name: tsClinical DDworks21 GlobaltsClinical X-Management Monthly Fee (excl. Tax): Pricing will vary depending on service config Availability: September 2012
About Fujitsu Limited
Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Over 170,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 4.5 trillion yen (US$54 billion) for the fiscal year ended March 31, 2012. For more information, please see www.fujitsu.com.
Source: Fujitsu Limited
Contact:Fujitsu Limited Public and Investor Relations www.fujitsu.com/global/news/contacts/ +81-3-3215-5259
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