The CRO first deployed Oracle Clinical and Oracle Database in 2003 as the standard and foundation for its clinical trial data management operations.

With Oracle RDC 4.5.3, Pivotal – which conducts approximately 95 clinical trials annually in Europe of which approximately 30 are new trials – expects to improve the efficiency and accuracy of clinical data collection and accelerate database lock times from months to a few weeks for some trials.

The application, which uses electronic case report forms (CRFs), is helping Pivotal to increase operational efficiency by reducing the administrative and material costs associated with processing paper-based forms.

Pivotal has expanded investigator access and eliminated firewall issues at study sites with the completely Web-based Oracle RDC 4.5.3.

The application provides investigators with an improved user interface for easier navigation and tools – such as the Patient Data Report that provides a single PDF file of all CRFs entered for a single patient – that help busy site personnel efficiently locate and manage patient data.

Pivotal selected Oracle’s Siebel CTMS to support its growing clinical research division with real-time information and greater visibility into its clinical trial portfolio. The application will replace an in-house developed system that had limited scalability and was increasingly complicated to manage and maintain.

Pivotal also expects to take advantage of the system’s flexibility in managing all aspects of clinical study planning, preparation, performance and reporting, and its ability to enable views that range from global to granular.

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