Aug 20, 2015

PIVOTAL RDC Onsite system upgrade to version 5.1

Pivotal selected and rolled out Oracle Clinical as its Data Management System back in 2003 and since then this system was hosted, serviced, validated, maintained and continuously updated which has allowed Pivotal to build up a strong and solid internal expertise to service its clients throughout Europe, USA and elsewhere. Oracle Clinical is one of the internationally validated Data Management Systems accepted by major Health Authorities, including the FDA and EMA. As part of Pivotal continuous efforts to offer our clients the most first-in-class, updated and validated systems in this area, Pivotal´s  Data Management Team has focused its efforts during the last 4 months on incorporating the latest updated version 5.1 and creating the appropriate platform to launch new studies and migrating the current ones over to version 5.1. During the last few weeks our IT and DM departments successfully achieved the migration of our Oracle Clinical system to the latest version, 5.1.  After carrying out a wide range of validation and quality assurance procedures, the system has now been released and incorporated within our functional systems.

Pedro M. Lledó, MD and Director of the DM and IT Departments at Pivotal commented, "The team at Pivotal is very excited to be able to take advantage of the new features in Oracle Clinical 5.1. For example, the new interface, partial source data verification, dynamic studies and pages, more robustness, and many other user-friendly features. I´m sure that  this new version will help drive the productivity of our Data Management processes while maintaining top class quality system, allowing us also to be in a better position to integrate Risk Based Monitoring processes within our operational systems".

"Pivotal thrives to continuously incorporate the latest technological  advances in the clinical development arena to offer our clients first-in-class services within the clinical trials value chain. We sincerely thank all of those who participated in making this a reality", added Dr Ibrahim Farr, Pivotal´s Chairman & CEO.