Quanticate has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services.

QVigilance will be focused on supporting small and mid-size companies transitioning from clinical trials to post-marketing and establishing compliant PV systems. Quanticate offers the full range of global PV services to clinical trial sponsors and market authorization holders (MAHs) in the pharmaceutical, biopharma and medical device sectors including:

• Case processing and reporting
• Global and local literature screening
• Aggregate production and reporting
• Signal and risk management
• Regulatory intelligence and guidance for regional markets.

David Hukin, managing director of QVigilance said: “The launch of Qvigilance is testament to that ethos as we add a dedicated PV service to help ensure our customers achieve and remain compliant with local, regional and global regulatory requirements and guidelines. There has been a notable increase in demand for outsourced PV services in the CRO market and there is an opportunity for pharmacovigilance CROs with the capabilities to provide global and regional support to become key partners for pharmaceutical, medical device, neutraceutical and generics companies.”

The company will also provide EU-specific support including EudraVigilance registration and management, creation and maintenance of the Pharmacovigilance System Master File (PSMF) as well as offering an EU Qualified Person responsible for Pharmacovigilance (QPPV) to support and oversee client portfolios.