VertexPV Analytics
We provide innovative pharmacovigilance solutions designed to meet the growing needs of global clients. Our team ensures compliance, safety, and performance with cutting-edge tools and services tailored to your needs.
Our mission is to enhance global safety standards through reliable technology and highly skilled professionals who are committed to excellence.
Services
Product Development
Focuses on creating innovative solutions to enhance safety and efficiency in pharmacovigilance processes. Key developments include a reconciliation tool for seamless data alignment, rule-based data validation to ensure accuracy, and real-time monitoring dashboards for proactive oversight. Advanced reporting systems and E2B parsers facilitate streamlined data exchange, while NER models enable precise extraction of critical information. Templated data summarization ensures consistency, and real-time alerts for late SAE submissions enhance compliance and responsiveness.
Systems Upgrade or Migration
Moving from an older system (e.g., ARISg, Argus, LSMV) to a newer, more advanced pharmacovigilance database (e.g., Oracle Argus, Veeva Vault, etc.): This process ensures the seamless migration of safety data from one system, database, or format to another while maintaining the integrity, completeness, and accuracy of the data. Merge/Acquire Organizations Consolidating safety data from different companies or systems following a merger or acquisition. Compliance with Regulatory Requirements Adopting systems that meet updated regional or global regulatory standards for safety reporting.
Data Analytics
Adverse Event Reporting: Analyzing data from adverse event reports (e.g., Individual Case Safety Reports (ICSRs)) submitted by healthcare professionals, patients, and pharmaceutical companies. Identifying patterns and trends in adverse drug reactions (ADRs).
Data Mining
Leveraging large datasets, such as spontaneous reporting databases (e.g., FDA Adverse Event Reporting System (FAERS), EudraVigilance), to uncover hidden relationships between drugs and adverse events.
Custom Reporting
Provides comprehensive and tailored insights by including adverse event trend analysis, product-specific safety summaries, in-depth risk-benefit assessments, regulatory-specific documentation, and the preparation of detailed aggregate reports. These reports encompass various formats, such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), CIOMS forms, and MedWatch submissions, ensuring compliance with global regulatory requirements and supporting informed decision-making.
Vendor Management and OverSight
Effective collaboration and operational excellence are achieved through robust governance and communication strategies, performance monitoring, and comprehensive contract management. This includes technical oversight, proactive risk management, and the development of business continuity plans to ensure minimal disruptions. Additionally, it emphasizes adherence to regulatory compliance and the facilitation of ongoing training programs to align with organizational objectives and industry standards.