CTI Clinical Trial and Consulting Expands Use of Oracle Applications

November 3, 2008

Company News Release

CTI upgrades to new releases of remote data entry and adverse event reporting products from Oracle

CTI Clinical Trial and Consulting Supports Growing Business with Expanded Oracle Clinical Footprint
Use of Oracle® Remote Data Capture Enables More Agile Reporting to Regulatory Organizations
Redwood Shores, CA – November 3, 2008
News Facts
· CTI<http://www.ctifacts.com/> Clinical Trial and Consulting Services (CTI)<http://www.ctifacts.com/> is upgrading and expanding its use of Oracle applications for clinical development to support the company’s continued growth in the U.S. and global markets.
· CTI, a specialty drug and market development company based in Cincinnati, Ohio, has recently upgraded to the newest releases of Oracle® Clinical<http://www.oracle.com/industries/life_sciences/oracle-clinical-data-sheet.pdf> and Oracle Adverse Event Reporting System<http://www.oracle.com/industries/life_sciences/aers45_datasheet.pdf>.
· The company is also upgrading to Oracle Remote Data Capture 4.5.3<http://www.oracle.com/industries/life_sciences/rdc-onsite-datasheet.pdf>, Oracle’s electronic data capture (EDC) solution, to leverage new functionality designed to meet the needs of trial sponsors and investigative site personnel, including the product’s zero-client footprint that enables improved global access.
· The growing company, which serves more than 50 biotech and pharmaceutical organizations globally is expanding its Oracle footprint with the deployment of Oracle Clinical Trial Management System<http://www.oracle.com/applications/crm/siebel/resources/siebel-lifescience-clinical-trial-management-system-data-sheet.pdf>, moving from a system developed in house to a best-of-breed solution that provides greater scalability and flexibility in managing all aspects of clinical study planning, preparation, performance and reporting.
· The company focuses on developing therapies targeting very ill patients. The clinical trial process for such drugs often requires more frequent, extensive and rapid reporting to a trial’s Data Safety Monitoring Board (DSMB), an independent body responsible for assessing a study and its risk.
· With Oracle Clinical and Oracle Remote Data Capture, CTI can quickly deliver data to a DSMB or regulatory agencies, such as the U.S. Food and Drug Administration (FDA), without the need to key in information from paper case report forms (CRFs) – a process that is time consuming and presents opportunities for data entry error.
· CTI conducts approximately 60 percent of its trials using EDC technology.
· The 10-year old company invested in industry-leading Oracle Clinical applications at its inception to help credential it in the market.

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