Clients have increased expectations for overall PV oversight in several key processes such as case processing, regulatory submissions compliance, partner distribution compliance, and case quality. Solutions need to be provided in a real-time, user-friendly format that allows simple data visualization, filtering, and exporting to answer different needs and ensure oversight. In addition, information must be easily and readily accessible to the client.
The UBC PV Tableau Data Analytics Platform provides an all-in-one dashboard system for safety Key Performance Indicators (KPIs) analysis and compliance oversight to manage project-specific needs with real-time data visibility.
This powerful analytics platform delivers a user-friendly dashboard with unique advantages for clients, including:
- Seamless integration with Argus safety database
- Flexible data connection options to meet any extraction, timing, or security requirement
- UBC’s standard Argus safety data models are fully customizable to meet client needs
- Comprehensive program oversight
- Oversight of full data history created and retained for direct integration into custom reporting and analytics suite
- Intuitive, dynamic visual dashboard suite
- Multi-layered, visual-based, interactive dashboards to filter and craft personal views, export visuals and data, and set alerts for key metric thresholds or activities
- Designed to facilitate operational efficiency, ease of use, and deliver actionable insights through a best-in-class platform
- Easy accessibility
- Available online, on-demand, and on any device
- Direct delivery of standard or custom report views through self-service email subscriptions
- Individual licensing and credentials assigned through role-based user groups for customized access
- Convenient customization
- Monitor every facet of PV project operations from day one with standard dashboard
- Efficiently customize new dashboards to meet unique program needs
The standard dashboards include:
- Project Summary: Overall case processing project metrics in one view (case volume with month over month trending including case counts and possibility to filter by date, source, country, seriousness, report type, version, and more)
- Project Metrics: Manage submission timelines and visualize global compliance, including expedited submission to regulatory authorities and/or partner distribution metrics, and identification of late case details, including deviations and root cause function
- Action Items: Ensures the UBC team has good oversight of the case processing action items within the safety database and allows visualization of compliance metrics for those action items
- Live Case Processing: UBC internal workflow management tool that allows for monitoring of case volume distribution in different case processing active workflows, timeliness of cases in each workflow step, and compliance with case processing timelines, as agreed between UBC and client
- Quality Control (QC): Used by the UBC team to keep oversight of the accuracy and completeness of cases, and identification of potential QC trends that require an action
UBC works with each client to identify the key metrics at the initiation of any program to ensure the dashboards provided are clear and meaningful while demonstrating project progress and quality, as well as efficiencies.
ABOUT UBC:
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers customized solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
ABOUT THE AUTHOR:
Helena Pedrosa, PharmD, PhD, Associate Director, Global Case Processing, Pharmacovigilance
Helena Pedrosa joined UBC in October 2012. Ms. Pedrosa has 11 years of expertise in the pharmaceutical industry and holds a PharmD and a PhD in Toxicology from the University of Porto (Portugal). Dr. Pedrosa has experience at UBC as a Safety Data Associate, Safety Scientist and Team Manager for multiple clients. Dr. Pedrosa has a proven record in end-to-end case processing of clinical trial & post-marketing cases (including managing large case processing volumes using case intake automation) and regulatory compliance and is a Subject Matter Expert for scientific literature monitoring for PV. Dr. Pedrosa currently manages several operational teams performing end-to-end case processing, expedited reporting, literature monitoring, safety database configurations & output requests, generation of Tableau Data Analytics metrics & client-specific KPIs, reconciliation activities, and local PV activities.
