Daiichi selects SAS to transform how clinical trials data are captured, accessed and utilised

May 23, 2005

Applied Clinical Trials

Integrated with several leading best-of-breed solutions, SAS® Drug Development to enhance research efforts of innovative global pharmaceutical firm

23 May 2005 - SAS, the leader in business intelligence, today announced that Daiichi, a global pharmaceutical firm, will innovate its clinical development processes by using SAS Drug Development as the centrepiece of a suite of hosted solutions. The integrated system will enable Daiichi to outsource its clinical trials IT infrastructure and allow its staff to focus on core research functions.

Anchored by SAS Drug Development, the suite of leading-edge clinical trials software solutions will fulfil Daiichi's needs to capture, access, manage and utilise clinical trials data by providing electronic data capture (EDC), data integration, medical event auto-encoding, data visualisation, and data analysis and reporting capabilities.

"Our core competency is the development of new medications, not the creation and maintenance of a clinical data management system," said Ron Fitzmartin, Ph.D., MBA, Vice President of Global Technical Services for Daiichi Medical Research, Inc. "This system with SAS Drug Development at its core will enable Daiichi to eliminate paper-based systems - and the inevitable errors that result from the use of these systems - and help us make quicker decisions about which compounds hold the most promise."

SAS Drug Development software builds on the breakthrough capabilities of the SAS9 Intelligence Platform to remove the obstacles in sharing data and applications across organisations and deliver the foresight and understanding required to succeed. Available as a standalone or hosted solution with access via a secure, thin client, SAS Drug Development provides a centralised repository that allows life sciences firms to analyse their clinical research for regulatory submission and explore new market opportunities, product line extensions and safety issues - all within a controlled and secure collaborative framework designed for life sciences research industries. SAS Drug Development has been designed to meet federal regulations such as 21 CFR Part 11, good industry practices and sound business practices.

Daiichi will use SAS Drug Development in conjunction with three other hosted solutions:

  • DATATRAK Aware(tm) - Powered by SAS, which combines DATATRAK's electronic data capture (EDC) solution with SAS Drug Development. This joint offering allows for rapid data capture and processing.
  • Galt Associates ' market-leading coding management solution - dsNavigator(tm) - that combines sophisticated functionality for searching, navigating, batch and interactive auto encoding, and dictionary management into a single, customisable, Web-based application.
  • Integrated Clinical Systems' Integrated Review(tm) and JReview, tools for clinical data review, reporting, multi-dimensional analysis, graphics and statistical modelling.

By employing this combination of solutions, Daiichi will be able to bypass a traditional clinical data management solution (CDMS), which would require a massive capital investment in IT infrastructure and a dedicated staff to install, configure and maintain the system. Plus, a traditional CDMS is designed to support a process for paper-based clinical trials. Fitzmartin believes investing today in a paper-based, transactional CDMS would be a waste of time and money.

"Changes are underway that allow data managers to spend less time on resolving data discrepancies and more time collaborating with statisticians and clinicians to facilitate rapid access to the data needed for review and decision making," Fitzmartin said. "To succeed in this transformation, the industry is eliminating transactional, paper-based processes and moving toward flexible systems like DATATRAK that streamline the process of capturing clinical trials data and pipelining the information into a SAS based repository specifically designed for data review, analysis and reporting. The scalable data repository then can be leveraged to facilitate the warehousing and mining of integrated efficacy, safety and pharmacogenomic data."

The suite of solutions hosted by SAS Drug Development for Daiichi reflects SAS' commitment to flexibility and innovation for the life sciences industry. The unique combination of solutions from SAS, DATATRAK, Galt Associates and Integrated Clinical Systems allows executives at Daiichi to select and seamlessly integrate the premier clinical trials software on the market today, creating a fully customised, cost-effective system tailored to meet the company's specific needs.

About SAS
SAS is the market leader in providing a new generation of business intelligence software and services that create true enterprise intelligence. SAS solutions are used at more than 40,000 sites - including 96 of the top 100 companies on the FORTUNE Global 500 - to develop more profitable relationships with customers and suppliers; to enable better, more accurate and informed decisions; and to drive organisations forward. SAS is the only vendor that completely integrates leading data warehousing, analytics and traditional BI applications to create intelligence from massive amounts of data. For nearly three decades, SAS has been giving customers around the world The Power to Know.