01.16.19
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:
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.
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.
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.