Argus Safety & PV Applications Support & Upgrade

Argus Safety & PV Applications Support & Upgrade

Our client is a global biopharmaceutical company focused on developing innovative medicines to address unmet needs of people living with mental illness, addiction, and cancer.

CHALLENGE

Our client was looking for support in their Drug Safety Pharmacovigilance Systems & Analytics team. They needed a consultant to help them in database validation and configuration activities, in the fulfillment of data requests and process improvements and resolution of technical issues.

They had several projects to complete, one of which was to enhance their Oracle Argus system, to include the upcoming regulatory requirements for combination (drug & device) reporting. They needed to extend the system to automate the submissions to the regulatory agencies worldwide.

APPROACH

Talent Groups provided a consultant that had experience with the safety system (Argus Safety) including PV operations, technical, and analytical skills as well as strong knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.

Our consultant collaborated cross-functionally with teams such as PV Operations, Aggregate Reporting & Signaling, Quality & Compliance, Clinical, Regulatory, Computer Systems Validation, Clinical Quality Assurance, Epidemiology, and R&D, to understand and analyze the impact and scope of the projects.

They developed and implemented system changes including product configuration, study/protocol configuration, workflow and process changes, user access changes, etc. They also organized data to facilitate analysis for aggregate data review as well as for signaling activities.

IMPACT

Our consultant fully integrated into the client’s team and provided expert support across multiple initiatives, remaining engaged for more than two and a half years. Following the successful completion of these projects, the client gained the ability to independently manage and govern all local and global submissions within the Safety System. In addition, they standardized and harmonized processes across reporting and signal management activities, improving consistency, efficiency, and compliance.