Quanticate, a global data-focused clinical research organisation, has introduced QVigilance to offer dedicated pharmacovigilance (PV) and risk management services, it was reported yesterday.

The service will concentrate 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 authorisation 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.

The company is also offering EU-specific support including EudraVigilance registration and management, creation and maintenance of the Pharmacovigilance System Master File and offering an EU Qualified Person responsible for Pharmacovigilance to support and manage client portfolios.