Leading Pharmaceutical and Contract Research Organizations Use Oracle(R) Clinical Trial Management Solutions to Streamline Trial Management and Expedite Regulatory Compliance
Oracle today announced that more than 240 major life sciences companies, contract research organizations (CROs) and academic research organizations use Oracle(R) clinical applications to help improve operational efficiency, expedite multinational regulatory approval processes and reduce cycle times in critical clinical trial processes. Overall, 29 of the 30 largest pharmaceutical companies run Oracle applications. (1)
“Oracle — through its suite of solutions for clinical trial management — offers the only truly integrated data management and electronic data capture (EDC) solution, enabling life sciences organizations to streamline the capture and management of clinical trial data and accelerate time to market,” said Mychelle Mowry, vice president, global health industries, Oracle. “Pharmaceutical companies, academic research centers and CROs are taking advantage of our seamless integration to eliminate redundancy in remote data capture; track adverse events from multiple sources; streamline their ability to respond to regulatory inquiries; summarize medical terminology consistently; and conform to global standards.”
Integrated Approach Yields New Efficiency
Sepracor Inc., a research-based pharmaceutical company focused on the development of drugs to treat and prevent respiratory and central nervous system disorders, has implemented Oracle clinical applications to improve the efficiency and effectiveness of its clinical trial and pharmacovigilance processes. The Massachusetts-based organization has implemented Oracle Clinical, Oracle’s comprehensive trial management solution, as well as Oracle Adverse Event Reporting System (AERS), a robust solution for product safety monitoring and compliance that tracks events from multiple sources, including the Internet, patients and physicians.
“Our ability to implement Oracle Clinical ‘out of the box’ without customization was an important consideration in our vendor selection process,” said Beth Atkinson, senior director of Clinical Data Management, Sepracor. “In the past, we outsourced management of all trials. While we still rely heavily on CROs, Oracle Clinical enables us to manage a select number of trials in house.”
The integrated nature of Oracle Clinical also gives Sepracor the ability to manage clinical trial data in a single system for improved accuracy, visibility and data integrity. “We ultimately look forward to linking Oracle Clinical and TMS with Oracle AERS to enable end-to-end quality management and facilitate regulatory compliance,” said Atkinson.
Strength in CRO Market
Oracle Clinical continues to gain momentum in the CRO sector. PPD, based in Wilmington, N.C., has implemented a broad portfolio of Oracle Clinical solutions to streamline management of clinical trials for its global customer base. With more than 700 users, PPD has one of the largest Oracle Clinical installations worldwide.
Most recently, PPD implemented Oracle Remote Data Capture (RDC) to provide a full-service EDC solution for clinical trials to their customers. Because Oracle RDC is fully integrated with Oracle Clinical, PPD is able to leverage its existing product knowledge, functionality and infrastructure in applying this EDC technology.
Oracle RDC offers PPD the scalability and functionality required for onsite data entry of Phase I-IV clinical studies. A 21 CFR Part 11-compliant system, Oracle RDC provides PPD with real-time data cleaning and reporting capabilities, integrated medical and adverse event coding, as well as discrepancy management — all with powerful encryption technology to protect the security and confidentiality of study data. Oracle RDC also allows users to enter data in an Adobe portable document format (pdf) that replicates the layout of traditional paper case report forms, elevating the end user’s comfort level with the EDC solution.
“By integrating Oracle RDC with PPD Patient Profiles, a data review tool, we have significantly reduced review time from the industry standard,” said Liz Rolison, vice president, Information Technology, PPD. “We are able to reach database lock more rapidly, thus achieving both time and cost savings for our clients.”
At Clinimetrics, Inc., a global, full-service CRO based in San Jose, Calif., Oracle clinical applications have been fundamental to expansion of the company’s service offerings. Before implementing an Oracle clinical trial management solution, the company was limited to providing clinical monitoring onsite. Today it offers a complete array of integrated research services including clinical and data management, project management and biostatistics, as well as quality assurance, regulatory and medical affairs offerings.
Over the past five years, Clinimetrics has implemented and validated multiple applications in the Oracle clinical application suite, including Oracle Clinical, Oracle Thesaurus Management System (TMS) and Oracle AERS. The organization also recently implemented Oracle RDC, enabling it to capitalize on the growing need for and acceptance of EDC-based trials.
“Oracle Clinical provides a complete solution in one database application,” said Joe Laver, Senior Director of Clinical Data Management. “One of the solution’s strongest points — in addition to its integrated laboratory data management capabilities — is its powerful discrepancy database, which identifies issues in real time, alerting us to possible data discrepancies conflicts when they happen.”
North Carolina-based INC Research, which provides therapeutically specialized drug development services to customers worldwide, was an early adopter of Oracle Clinical applications, having consulted in the development and testing of various modules. INC Research has developed an expertise that comes from longstanding use of Oracle to manage its clinical trial process, most recently implementing Oracle TMS and Oracle RDC.
“We work almost exclusively in Oracle Clinical, as it is a very reliable system,” said Anne Wiles, president, INC DataSpectrum, a division of INC Research that provides data management solutions. “We need to be experts in the tools we use to provide best of class service to our customers, and we can achieve this goal by standardizing on Oracle Clinical applications. The end result is a higher level of service and expertise for our clients.”
The company recently completed a migration to Oracle Clinical 4.5, the product’s most recent release. “Our end users have been extremely receptive to Oracle RDC’s new interface, which is more intuitive and user friendly,” said Wiles.
About Oracle’s Clinical Applications
Oracle is the leading vendor of clinical trial management applications, providing pharmaceutical companies and CROs with multiple tools to improve operational efficiencies. Oracle’s clinical trial applications manage all aspects of clinical data, including multilingual and remote data capture, entry and monitoring. Together, Oracle Database, Oracle Application Server and Oracle’s clinical trial applications consolidate data into a single database, enabling researchers to draw on accurate, consistent information, as well as standardize and control data definitions and usage across a global operation. They also expedite multinational regulatory approval processes and reduce cycle times in critical trial processes. In addition, Oracle TrialMinder and Oracle SiteMinder solutions provide administrative control of large volumes of data coming from multiple clinical sites.
About Oracle
Oracle is the world’s largest enterprise software company. For more information about Oracle, visit our Web site at www.oracle.com .
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(1) Top 30 Pharmaceutical companies are based on 2003 annual revenue source: Pharmaceutical Executive Magazine
