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.
"Quanticate is an experienced niche biometric CRO supporting a wide range of customers and we are always working to further our expertise and service offering,” 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.”
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.
"It is a natural progression for Quanticate to expand its capabilities through the launch a company dedicated to delivering PV services. It's an area where we have always supported clients and we have the expertise and experience required to contribute to their continued success," Hukin said.
Oracle Argus is a fully validated safety database, which enables quality and efficiency in handling safety data. In accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), this allows continuous evaluation of the risk-benefit profile of products throughout the product lifecycle.