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Company News Release
[Cincinnati, Ohio; January 12, 2009] CTI Clinical Trial and Consulting Services (CTI) announced that it 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 has recently upgraded to the newest releases of Oracle® Clinical, Oracle Adverse Event Reporting System, and Oracle Remote Data Capture 4.5.3, Oracle’s electronic data capture (EDC) solution to leverage new functionality designed to meet the needs of trial sponsors and investigative site personnel.
CTI, which serves more than 50 biotech and pharmaceutical organizations globally, is expanding its Oracle footprint with the deployment of Oracle Clinical Trial Management System, 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.
CTI focuses on developing therapies targeting critically 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, 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, without the need to key in information from paper case report forms-a process that is time consuming and presents opportunities for data entry error.
The 10-year old company invested in industry-leading Oracle Clinical applications at its inception to help credential it in the market.
“We invested in Oracle’s clinical applications suite from the very start of our organization because it is a leader that has the confidence of the biotech and pharmaceutical industry. Over the years, Oracle has been very flexible and eager to work with our emerging organization, playing an important supporting role in continued growth,” said Kevin Schwarz, Senior Vice President, Clinical Trial Operations.
“We view the launch of the Oracle Health Sciences Global Business Unit last year as a very positive development, further strengthening Oracle’s commitment to and expertise in the industry. We are also eager to explore the value that Oracle’s movement toward expanded integration among its clinical applications can deliver to organizations like ours,” said Tim Schroeder, President and Chief Executive Officer.
“CTI, through its long-time commitment to and success with Oracle Clinical applications, demonstrates how emerging life sciences organizations can leverage Oracle applications to help drive growth and value within their organizations,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences Global Business Unit. “CTI is a compelling example of how Oracle applications can help life sciences organizations accelerate insights for better health, and we look forward to our continued relationship.”
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services (CTI) is a specialty drug and market development company offering a full range of services that encompass the entire lifecycle of drug development. These services include regulatory pathway design, clinical trial management, data analysis, medical writing, CME and training program development, market analysis and development and other consulting services. CTI focuses on critically and chronically ill patient populations in the specific disease areas of solid organ transplant, hepatitis, infectious disease, hematology/bone marrow transplant and end-stage organ disease including cardiovascular disease, liver disease and kidney disease. With its combined expertise of clinical knowledge and market experience, CTI is uniquely positioned to incorporate both clinical and market driven endpoints and interpretations to provide results.