July 12, 2012
Fujitsu Limited
Supports global clinical trial regulations, helps
reduce risk and development costs
Tokyo, July 12, 2012 - 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
Pricing and Availability
|
Product Name
|
Price/Monthly Service Fee (Excl. Tax)
|
Availability
|
|
tsClinical
|
DDworks21 Global
|
Pricing will vary depending on service configuration
|
September 2012
|
|
X-Management
|
About Fujitsu
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 http://www.fujitsu.com.
Press Contacts
All company or product names mentioned herein are
trademarks or registered trademarks of their respective
owners. Information provided in this press release is
accurate at time of publication and is subject to change
without advance notice.
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