OREANDA-NEWS. 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.