Release of Oracle Clinical version 5.2

The Oracle Clinicial version 5.2 is in compliance with 21 CRF part 11. “Oracle Clinical version 5.2, with its new capabilities, including a significant upgrade in the Technology Stack and new end user functionality, brings a great improvement for all EDC users in Pivotal's-run studies,” says Francisco José Montané, Director Data Management.

The new version has been deployed in our qualified Azure Cloud Environment, has been fully validated to comply with 21 CRF part 11 and brings several advantages to Pivotal and our clients:

Technology Stack Upgrade: To ensure the longevity of the supported technology stack, now Microsoft Edge and Google Chrome are supported browsers in RDC Onsite

Deleted but Not Re-entered CRFs: Patients that have deleted but not re-entered CRFs can be identified and a report to view audit history for these CRFs can be generated

Enhanced Patient Data Report (PDR): Includes ancillary pages by default. PDRs include audit history, investigator comments, and overflow footnotes. Optionally, verification history can be also included for any CRF where applicable

Ability to Define Custom Review Requirements: Custom review requirements for each CRF in a study can be identified, for example Data Management Review. Hence, Data Managers will see the "Review Required" indicator for each CRF that requires review according to the specifications

ABOUT PIVOTAL

Founded in 2001, Pivotal is a leading full-services CRO offering services to the healthcare industry across Europe. We take on the immense challenges for supporting cutting-edge clinical development programmes with IMPs, medical devices, diagnostics and nutrition products. Our clients enjoy the benefits of senior management hands-on environment, operational teams working on the ground with the clinical sites, deep therapeutic expertise and cost-effective deliverables. We share our clients objectives and deliver a solid programme to achieve promising results.