agVet facilitates the capture and assessment of all animal adverse events and ensures regulatory compliance with veterinary reporting guidelines
STAMFORD, CT— January 7, 2014– ArisGlobal, a leading provider of solutions to the life sciences industry, today announced the launch of agVet, an end-to-end veterinary pharmacovigilance solution tailored to address the pharmacovigilance and regulatory reporting needs of veterinary marketing authorization holders.
As veterinary medicines legislation evolves across the globe, companies are required to capture and submit reports in the formats defined by the different regulatory bodies, which include electronic reporting. “With an increased focus on veterinary medicine and specifically adverse event reporting, it is essential to improve the way veterinary adverse event cases are processed” commented Simon Sparkes, senior vice president, Quality & Compliance at ArisGlobal. “agVet is specifically designed for veterinary pharmaceutical companies to streamline the process of capturing, tracking and reporting of all safety events related to veterinary medicines.”
Developed in partnership with a major regulatory agency, agVet is a comprehensive pharmacovigilance solution that enables veterinary pharmaceutical companies to create, code, assess and submit adverse event reports in the formats mandated by global, regional and local regulatory authorities including the EMA and the FDA. The other key benefits of agVet include:
• Electronic submission and exchange of veterinary safety data in XML format as defined
in the EudraVigilance access policy for medicines for veterinary use
• Flexible and powerful workflow for case processing and report distribution that can be customized
based on the business process for improved efficiency and productivity
• Capability to code cases against VeDDRA product terminologies to ensure accuracy and consistency
while improving quality and efficiency in the reporting process
• Intuitive role-based dashboard of critical metrics, KPIs and compliance data
• Tracking and monitoring of all regulatory submissions, follow-up, correspondence and
imminent commitments with regulatory authorities to ensure timely resolution
agVet is available to customers as a licensed, on-premise solution or as a hosted solution via agOnDemand™, ArisGlobal’s highly proven Software-as-a-Service (SaaS) delivery platform.
ArisGlobal (www.arisglobal.com) is the leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries. Solutions are available on premise or on a regulated cloud platform. Life science companies using ArisGlobal’s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world.
Tel + 44 (0)1908 506075