Perceptive Informatics and Fujitsu Systems West Limited Integrate Data Management Technologies to Enhance Clinical Trial Effectiveness in Japan
ClinPhone® RTSM and DDworks 21™ streamline and expedite data collection and access to provide clients with greater clinical insights
Tokyo, October 9, 2013 – Perceptive Informatics, a leading eClinical solutions provider and technology subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), and Fujitsu Systems West Limited (FWEST), a regional systems engineering company of Fujitsu, today announced a technology partnership to improve clinical trial data management in Japan.
Through the collaboration, the companies have integrated Perceptive’s ClinPhone® RTSM (Randomization and Trial Supply Management) solution and Fujitsu’s DDworks 21™ Clinical Trial Management System (CTMS). The new offering automatically transfers data from ClinPhone® RTSM into DDworks 21™. In addition to eliminating manual data entry, it makes study logistical information immediately available for proactive decision making.
“Clinical trial management is often hindered by complex, time-consuming, manual processes for collecting, aggregating and rationalizing data,” said Graham Bunn, Vice President of Partnerships, Perceptive Informatics. “Integrating our industry-leading technologies will replace fragmented methods for capturing and leveraging data. By streamlining these processes, clients can conduct clinical trials more efficiently.”
Built on the Perceptive MyTrials™ platform and combined with PAREXEL’s clinical expertise, ClinPhone® RTSM utilizes validated randomization methods, automated inventory control, dispensing and titration management, emergency code break capabilities and real-time supply reporting. It also provides sophisticated reporting to monitor trial management performance, analyze trending and forecasting information, and deliver in-depth data analysis. Global clinical trials can be supported in multiple languages through the solution’s secure access, detailed audit trails, transaction logging, and compliance with US FDA 21 CFR Part 11 and Japan MHLW ER/ES.
DDworks 21™, Fujitsu’s GCP risk management solution, is a leading software offering for clinical trial quality and regulatory compliance in Japan. Incorporating PMDA regulations and J-GCP guidelines, best industry practices and quality processes, it has been implemented by more than 80 pharmaceutical companies since 1996.
About Fujitsu Systems West Limited
Fujitsu Systems West Limited offers global solution services as a group company of Fujitsu. FWEST especially offers DDWorks21 (GCP management system) for pharmaceutical companies with high quality and safety. FWEST will continuously support pharmaceutical companies with ICT and provide trusted service, customer satisfactions and value in the future.
About Perceptive Informatics
Perceptive Informatics, a leading eClinical solutions provider and technology subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), provides solutions that help customers accelerate the drug development process through innovation. We enable our customers to maximize the benefits of an integrated clinical trial technology suite by providing flexible software-as-a-service (SaaS) applications and leading technology services. As the technology subsidiary of PAREXEL International Corporation, one of the world's leading CROs, we are able to leverage our investment in technology with our parent company’s hands-on clinical expertise. For more information visit www.perceptive.com.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 77 locations in 51 countries around the world, and ended the June quarter with approximately 14,700 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "will," "would," "could," "should," "targets," and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company's business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2013 as filed with the SEC on August 22, 2013, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation; Perceptive and Perceptive Informatics are registered trademarks of Perceptive Informatics, Inc.; and ClinPhone is a registered trademark of ClinPhone Limited. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.