PVantage™ Safety Data Automation
Pharmacovigilance Adverse Event Management Platform
PVantage is a modular offering, able to scale with your program as case volume increases.
PVantage™ is an innovative platform, that allows drug safety teams to streamline and automate case processing activities to ensure accuracy, efficiency, and compliance. This tool works with clinical trial and post market safety data and provides the ability to integrate, analyze, and visualize patient, program, and drug class information for greater control and oversight of your safety data.
PVantage is a proprietary cloud-based solution that allows Sponsors to elect the degree of automation of all workflows for case intake, case processing, safety data analysis and generation of standard reports. A dedicated, virtual managed environment provides Sponsors with a consistently updated platform and assures compliance with ever-changing global pharmacovigilance regulations.
Click to learn more about Comprehensive Safety Solutions to accompany this technology.
Allows for the automation and streamlining of case intake, including autopopulation of case data from a variety of sources
This module enables efficient and seamless data exchange between the Clinical electronic data capture (EDC) system and the Safety database, resulting in time reduction for case processing and data reconciliation while providing increases in quality.
PVantage dashboards allow for the visualization of complex safety data, making it easier to understand and interpret the data using a wide range of visualization options. The customizable data visualization layer allows for near real-time data inquiry and more informed decisions. In addition, sponsors can customize reporting content and cadence, including status reports, cumulative safety listings, KPIs, and other compliance reports.
With PVantage, Sponsors gain an accelerated technological advantage with greater visualization and efficient reporting of safety data.
Suggested For You
news
March 19th, 2025
MMS REMS-focused Technology bolsters Full-Service REMS Solutions
webinar
April 30th, 2025
Advancing Clinical Development with Innovative Trial Design and Regulatory Strategies
perspectives
March 6th, 2025
Overview of FDA Guidance for Industry on Assessment of Ovarian Toxicity in Premenopausal Adults During Development for Oncologic Products
webinar
March 25th, 2025
Overcoming NDA/BLA Submission Challenges: Practical Strategies for Success
perspectives
February 13th, 2025
Helping European Drug Development Companies Succeed in the US Market
news
February 12th, 2025
MMS Acquires Exploristics and KerusCloud Simulation Platform to Expand Biostatistics and Data Science Capabilities as a Global Data-Focused CRO
perspectives
January 30th, 2025
Post-PDUFA VII Updates: FDA Meetings Public Workshop & Lessons Learned
perspectives
January 21st, 2025
REMS Modifications and Revisions: A Retrospective from the Past 12 Months
regulatory intelligence
January 17th, 2025
The FDA’s AI Guidance and its Seven Steps into the Future of Drug Development
regulatory intelligence
January 17th, 2025
New FDA Protocol Deviation Guidance: Planning for the Things That Don’t Go According to Plan
perspectives
January 9th, 2025
How to Create Efficiencies When Creating Simultaneous NDA and MAA Submissions for the FDA and EMA
perspectives
January 2nd, 2025
Informed Consent in Clinical Research: Understanding its Significance and Sponsor Obligations