Augmenting Safety Services to Better Support Clients

Novella Clinical, Inc., a Quintiles company, is a full-service clinical research organization and an active partner to the oncology, medical device and biotech industries.

MIGRATING AND UPGRADING TO A BETTER PLACE

Novella wanted to augment safety services within its global safety management department to better support its pharmaceutical, biotech, medical device clients. The safety department serves Novella’s primary client base across drug, vaccine and device studies to support the collection, assessment and reporting of serious adverse events (SAEs).

After reviewing the available technology to support its needs, Novella selected Argus Safety, Oracle's comprehensive safety database and regulatory reporting system. Perficient then completed a data migration of approximately 1,500 cases from Novella’s previous safety application, as well as 14 upgrades of older Oracle Argus Safety databases to a single, multitenant, Oracle Argus Safety system.

With the upgrade, Novella improved safety-database and regulatory-reporting system efficiencies to more effectively support global, safety data collection and risk management across its business. Further, Argus Safety could now offer customizable reports across multiple datasets, allowing for a more comprehensive data review, which is essential with the heightened regulatory emphasis in the life sciences industry.

The solution improves the ability to support global safety data collection and risk management for oncology, device, and biotech companies and allows for a more comprehensive data review.

Merge, Upgrade, Streamline: One System for Many Customers

Perficient and Novella began with a meeting to determine how to best merge 14 Oracle Argus instances into one, while upgrading to the newest version of Oracle Argus Safety. This provided multitenancy functionality that enabled Novella to use one database for multiple clients and streamline maintenance.

Perficient worked with Novella to validate the system and complete the full server installation. This was one of the first-ever multitenant Oracle Argus implementations, so it was important for the team to develop a comprehensive installation document, which did not previously exist in the public domain. The team then moved into full functionality system testing, examining a suite of test cases and testing the latent functionality of the application, followed by system configuration and testing and user acceptance testing.

Next, Perficient worked with Novella to take the 14 disparate, older Oracle Argus Safety systems into a separate staging area, upgrade them to the newest version of Oracle Argus Safety, and then merge them back into the multitenant, fully validated system.

Perficient continues to provide Novella with system support.

A Special Solution for a Specialty CRO

  • Upgraded all existing legacy Oracle Argus Safety application instances to the newest version of Oracle Argus Safety, which improves the ability to support global safety data collection and risk management for oncology, device, and biotech companies and allows for a more comprehensive data review.
  • Merged relevant safety data from the legacy system into a fully validated, multitenant Oracle Argus Safety system, enabling the company to better monitor safety metrics and retire the previous safety system.
  • Customized reports across multiple datasets, allowing for a more comprehensive data review, which was essential given the heightened regulatory emphasis on early, safety signal detection.
  • Increased case processing efficiencies by implementing a department-wide electronic workflow system, where 100% of the files are electronic, eliminating paper case files; reducing printing, storage, and archival fees, as well as staff time.
  • Automated reconciliation of SAEs to compare key data points in the safety and clinical databases to quickly identify and resolve discrepancies, ensuring comprehensive SAE collection and processing.

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. Erin Hawkins - RN, MSN, Director of Pharmacovigilance, Novella

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