• Shire Pharmaceuticals, with headquarters in Basingstoke, UK, is using Oracle's Siebel Clinical Trial Management System with embedded analytics capabilities to create a single view of the company's global clinical portfolio for study directors and managers.
• Shire uses contract research organizations (CROs) to conduct the majority of its clinical trials. Prior to deploying Siebel Clinical Trial Management System, the company relied on a labor- intensive, spreadsheet-based system to track trial progress - a process that did not provide real-time information or support in-depth analysis.
• Siebel Clinical Trial Management System provides extended visibility and near-time information that enables a more accurate, up-to-date picture of any trial, allowing Shire to respond more quickly to issues or determine if a trial is producing better than expected results.
• Using Siebel Clinical Trial Management System, Shire has created a single repository that contains a complete portfolio of the company's clinical trials. The system, which provides ready access to trial information and robust reporting capabilities, eliminates the need to maintain additional spreadsheets or databases with trial information. In addition, it includes powerful analytics capabilities to assess trial information.
• Shire also is using the system to manage and audit trip reports - documents from clinical trial investigation site visits included in the trial master file sent to the U.S. Food and Drug Administration (FDA) upon submission. The company can easily conduct audits to help ensure that CRO personnel conduct site visits as required, as well as analyze raw data from reports.
• Shire worked with Oracle(r) Consulting to develop a clinical data exchange to enable easy import and export of file formats and to facilitate reporting.
• Shire Pharmaceuticals continues to expand its use of Siebel Clinical Trial Management System by incorporating budgetary control and planning into the system. The company is also deploying Oracle's Siebel Relationship Management Warehouse to expand analytical reporting capabilities.

Supporting Quote

• "With Oracle's Clinical Trial Management System, we have gained valuable, near-time visibility and insight into individual trials as well as our entire portfolio - allowing us to improve both the efficiency and effectiveness of our trials," said Kirstin Lees, Clinical Programs Associate Director, Shire Pharmaceuticals. "We can now respond faster to changing conditions, supporting our goal of accelerating the delivery of safe and effective products to the market."

Supporting Resources

• Oracle's Siebel Clinical Trial Management System
• Oracle in Health Sciences
• Shire Pharmaceuticals

About Shire Limited
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results. For further information on Shire, please visit the Company's website: http://www.shire.com.

About Oracle
Oracle (NASDAQ: ORCL) is the world's largest enterprise software company. For more information about Oracle, please visit our Web site at http://www.oracle.com.