Novella Clinical Supports Life Sciences Clients’ Global Safety with a Scalable, Safety Case-Management Platform
 
 

Novella Clinical Supports Life Sciences Clients’ Global Safety with a Scalable, Safety Case-Management Platform

Novella Clinical Inc. is a full service clinical research organization headquartered in Research Triangle Park, North Carolina. An active partner to the oncology, medical device, and biotech industries, Novella integrates its deep, clinical expertise with industry-leading technologies and a proven approach to support, streamline, and expertly resource the entire medical product development process. 

Novella Clinical wanted to augment safety services within its global, safety management department to better support its biotech, medical device, and pharmaceutical clients. The global, safety management 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, Novella chose Oracle to provide it with a comprehensive safety database and regulatory reporting system. Novella completed a data migration of approximately 1,500 cases from previous safety application as well as 14 upgrades of Oracle Argus Safety 4.2 to a single, multitenant, Oracle Argus Safety 7.0 system. With the upgrade, the company improved safety-database and regulatory-reporting system efficiencies to more effectively support global, safety-data collection and risk management across its business. Further, Oracle 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.

 
 

 
 

Challenges

A word from Novella Clinical, Inc.

  • “Oracle Argus Safety enables Novella to provide insights into a drug or device safety profile, which give our clients an edge in making swift, science-based decisions regarding their products. We find this to be especially valuable to our oncology and medical-device clients.” – Erin Hawkins, RN, MSN, Director of Safety Management, Novella Clinical Inc.

  • Enhance SAE processing services within the safety management department to better support biotech, medical device, and pharmaceutical clients
  • Improve the safety application’s ability to generate and automate aggregate and signal reporting for multiple clients, testing various drugs, vaccines, and devices
  • Monitor safety metrics across clients more easily to aid in clinical research management and staffing decisions
  • Streamline the information technology infrastructure to reduce the number of database instances and application servers required and improve pharmaceutical safety reporting
  • Implement a fully-electronic workflow to increase case processing efficiency

Solutions

Oracle Product and Services

  • Upgraded all existing Oracle Argus Safety 4.2 application instances to Oracle Argus Safety 7.0, 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 system with the help of Oracle partner BioPharm Systems, 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 departmentwide 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

Partner

Novella Clinical worked on the project with BioPharm Systems, Inc.—an Oracle partner and IT consulting company focused on the life sciences industry. It began with a kick-off meeting in June 2011, to determine how to best merge 14 Oracle Argus instances into one, while upgrading to Oracle Argus Version 7, which provided multitenancy functionality that enabled Novella to use one database for multiple clients and streamline maintenance.

BioPharm Systems worked with Novella Clincal to validate the system and complete the full server installation. This was only the second-ever multitenancy, Oracle Argus implementation, and 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, BioPharm Systems worked with Novella to take the 14, disparate, older Oracle Argus systems into a separate staging area, upgrade them to Oracle Argus Version 7, and then merge them back into the multitenant, fully-validated system. The team completed the base system go-live in October 2011, and finished migrating all data in November 2011. BioPharm Systems continues to provide Novella Clinical with system support.

“This was the second-ever, Oracle Argus 7 multitenant implementation, and we worked very closely with Oracle to address the implementation challenges,” said Rodney Lemery, vice president safety and pharmacovigilance, BioPharm Systems Inc. “We have a very positive working relationship with Oracle, and that benefited the customer. The collaborative spirit fostered by BioPharm Systems, Novella Clincial, and Oracle was a key component in the project’s great success.”