Global solution for Veterinary Safety and Phamacovigilance

As with human medicines, veterinary drug manufacturers are required to comply with complex legislation for reporting and analysis of adverse event data.

Veterinary pharmaceutical companies often rely on outdated, manual or disconnected IT systems lacking automation. In today’s times of electronic reporting, it is critical for companies to have comprehensive systems in place to not only automate the process of collection, tracking, reporting of all veterinary adverse events but also facilitate data analysis and tracking of all follow-up activities.

agVet™ alleviates the burden and risks associated with fragmented manual reporting process by streamlining the global safety reporting process with a well-defined workflow. Seamless integration with a portal and mobile applications simplifies the capture of adverse events while the process-driven workflow automates the case processing, follow-up communication and report distribution.

End-to-end solution for Veterinary Pharmacovigilance and Compliance
agVet is a complete solution for veterinary adverse event reporting and analysis. The system facilitates the capture and assessment of all adverse events by veterinary medicinal companies worldwide and ensures regulatory compliance with regional and global reporting requirements. A web-based system, agVet helps track all regulatory submissions and correspondence, enabling efficient management of follow-up communication.

Automatic data capture and superior user-interface
agVet enables veterinary drug companies to capture adverse events automatically from various sources and methods including email, portal, iPhone and iPad apps. The system uses state-of-the-art technology for centralized intake and triage of adverse event information. The easy-to-use user interface minimizes the training requirements and aids faster data entry, coding and report generation.

Regulatory Reporting formats
agVet provides the capability to create veterinary safety reports with all data elements mandated by global, regional and local regulatory authorities including US FDA and EMA. The system supports electronic ubmission and exchange of veterinary safety data in XML format as defined in the Eudravigilance access policy for medicines for veterinary use. agVet supports all major regulatory reports including E2B R2 XML,
FDA 1932, and CVMP.

Powerful workflow
agVet provides a powerful and configurable workflow that can be setup according to the organization’s business needs. Inbound cases are automatically placed in workflow and routed based on company SOPs and policies. Based on user roles and privileges, cases are routed to users for specific actions such as data assessment, coding and reporting for full compliance while the integrated communications and tasks modules
allow the user to track all follow-up activity.

Intuitive dashboard, charts and management reports
agVet’s powerful query and reporting tools allow instant access to all the data including case summary reports and responses eliminating the tedious and time-consuming process of compiling the data manually for analysis. Standard and custom reports and charts provide trending and analysis, while an intuitive dashboard provides a comprehensive view of the critical metrics and compliance data related to their role.

Capability to trigger alerts and notifications for activities that are due ensures immediate attention to high priority tasks. Reports can be generated in a variety of formats including PDF, Microsoft® Word, Excel or PowerPoint.

A proven solution from the market leader
ArisGlobal, the leading provider of pharmacovigilance solutions and regulatory compliance in human drugs has now extended its expertise also in the field of veterinary medicines. agVet is the all-in-one solution specifically designed to address the veterinary pharmacovigilance and regulatory reporting needs of the veterinary industry. The robust adverse event reporting system expedites the process of obtaining
market authorization contributing towards company’s profitability and better animal
health and safety.

Key benefits

  • Helps report veterinary safety data to meet regulations of global and national regulatory authorities including US FDA, EMA, CVMP, European countries, South Africa and Australia
  • Supports submission of electronic reports in XML format required by FDA and EMA EudraVigilance for veterinary products
  • Automates adverse event reporting with the help of pre-built report templates and knowledgebase of common questions and processes by building robust repository of FAQs, documents and literature
  • Automates case processing and report distribution with flexible workflows
  • Aids faster response to inquiries by tracking all regulatory submissions and correspondences in a single integrated view

Key functionalities:

  • Supports e-reporting of all standard reports including E2B R2 XML, FDA 1932, CVMP
  • 21 CFR Part 11 compliant
  • Automatic capture of AEs via portal, iPhone, iPad and email
  • Supports VEDDRA dictionary coding terminologies
  • Ad hoc reporting and personalized dashboards with standard and userdefined metrics/KPIs
  • User friendly data entry with duplicate checker, customized fields, option to add case notes and more