Adoption of Oracle® Argus Safety 7.0 Allows the Management of
Multiple Safety Datasets from a Single Platform
RESEARCH TRIANGLE PARK, N.C., January 12, 2012 - Novella Clinical, Inc., a full service contract research organization, today announced augmented services within its pharmacovigilance (PVG) department to better support its biotech, medical device and pharmaceutical clients.
Novella’s changes include an upgrade to Oracle Argus Safety 7.0, a comprehensive safety database and regulatory reporting system. Oracle Argus Safety allows Novella to provide efficiencies and the increased ability to support global safety collection and risk management. And with heightened regulatory emphasis on early signal detection, Argus Safety offers customizable reports across multiple datasets allowing for a more comprehensive data review.
Novella’s Director of Pharmacovigilance, Erin Hawkins, RN, MSN, noted, “Utilizing Oracle Argus Safety allows Novella to provide insights into a drug or device safety profile, which in turn gives our clients an edge in making swift, science-based decisions regarding their products. We find this to be especially valuable to our oncology and med device clients.”
Additionally, Novella’s PVG department is utilizing technology to increase efficiencies in case processing, including:
• Department-wide electronic workflow and case management (all files are 100% electronic), resulting in lower costs by eliminating paper case files, printing, storage and archival fees as well as staff time.
• Automated reconciliation of SAEs utilizing a proprietary SAS program to compare key data points from both the PVG and clinical databases. Periodic reporting against the data identifies discrepancies, and triggers a review by Novella’s PVG team and other relevant departments for resolution which greatly reduces reconciliation efforts on large, high volume studies.
The global PVG department serves Novella’s primary client base of oncology, device and biotech companies and works across drug, vaccine and device studies. Flexible in its approach, the department is able to tailor processes to support and perform SAE collection and processing on a variety of different types and sizes of studies.