Pivotal S.L. uses Oracle health sciences applications to accelerate clinical trial data collection and gain real-time visibility into studies

Redwood Shores 05 August 2009Pivotal S.L., a Spanish contract research organisation (CRO) and medical pharmaceutical consultancy group, has upgraded to Oracle Remote Data Capture (RDC) 4.5.3 and plans to use Oracle's Siebel Clinical Trial Management System (CTMS) to help it conduct and manage clinical studies more effectively and efficiently. 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.

"The expansion of our Oracle Health Sciences applications footprint with Oracle Remote Data Capture 4.5.3 and Oracle's Siebel Clinical Trial Management System will enable us to further improve the efficiency of our clinical trials and help our clients bring products to market faster and more cost effectively", stated Ibrahim Farr, Chairman and Chief Executive Officer, Pivotal S.L.

"Over the years, we have relied on Oracle Clinical and the Oracle Database to provide a solid and reliable foundation for our growing clinical trial and data management practice", stated Pedro M. Lledó, Director, Data Management and Information Technology, Pivotal S.L.

"Forward-thinking CROs, like Pivotal, are looking to bring new levels of efficiency to the clinical trial process, helping their clients to accelerate the delivery of safe, new products to market", stated Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. "Oracle's comprehensive suite of Health Sciences applications is at the forefront of this effort, delivering innovation and industry-specific functionality to help health sciences organisations address specific data management and business challenges, and ultimately accelerate insights for better health."

Pivotal S.L. is a privately held full-service Spanish CRO, with solid partnerships across Europe. Founded in 2001, Pivotal S.L. has grown significantly to become an expert CRO in its markets serving the multinational and local pharmaceutical and biotechnological industry across all therapeutic areas, with special emphasis on Oncology, Cell Therapy, Acute Cardiovascular, Diabetes, Central Nervous System, Immune-based, Infectious and other disease areas.

More Oracle news is available in the VMW July 2009 article US Oncology Inc. turns to Oracle to improve patient care with electronic health records system.

Source: Oracle

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