We provide integrated PV services for a variety of marketed pharmaceuticals, speciality medications and medical devices to meet or exceed your compliance to Health Canada GVP requirements.
Our expertise include: DINs (Rx and OTC), NPNs, Medical Devices and more.
We provide full support, local and global Individual Case Safety Report (ICSR) case processing, including bilingual end-to-end case processing of all your non-interventional ICSRs and reportable adverse events.
We perform literature search through diligent identification of relevant journals, and focused search with trade names and active ingredients. Our services include scientific literature screening to capture all reported ADRs using your products with full text review and assessment of safety information.
We offer periodic screening of Canada Vigilance Database (CVD) to identify all adverse events reported directly to the CVD and ensure they are captured in your PV database.
No matter how many products you have, periodic screening can be performed at a set frequency to ensure compliance to your SOP and to capture all AEs that were not spontaneously reported to your company otherwise.
Zenith offers an automated AI-enabled digital tool for Regulatory Authority website screening, compliant with applicable Health Canada guidelines.
Our technology is integrated with machine-translation capability to translate information from foreign sites.
We use validated and relevant key-word search to perform accurate signal validation and documentation of search results in a Health Canada-compliant format.
What is the Zenith difference in handling your safety data?
We can provide customised access to our fully validated safety database. This provides complete transparency across the case management lifecycle, and allows you to monitor the workflow and agreed Key Performance Indicators (KPIs)
Drug Safety is everybody’s responsibility.
While tailored to your needs, our comprehensive Pharmacovigilance (PV) training program is compliant with Good Pharmacovigilance Practices (GVPs) and will ensure your team has the required knowledge to perform routine and periodic PV responsibilities.
Additionally, Zenith provides onboarding PV trainings and periodic PV refreshers to all your employees to meet their AE reporting requirements.
This brief survey is designed to assess your company’s PV team capabilities and identify any gaps that may prevent you from meeting your PV compliance goals. At the end of the survey, please indicate if you want a free and confidential discussion with a senior Zenith partner.