Drug Safety and Medical Information
Sharing the responsibility of patient safety
Maintaining pharmacovigilance and medical information obligations is a critical part of bringing any medicinal product, medical device, or natural health product to market. We work alongside healthcare companies to carry those responsibilities together, across the full product lifecycle.
Maximizing safety. Minimizing risk.
Good Pharmacovigilance Practice (GVP) is the foundation of patient safety and public confidence in medicines. Whether you are delivering pharmaceuticals, medical devices or natural health products to patients, we offer complete solutions that maximize patient safety and minimize manufacturers’ risks.
Demonstrating product safety and quality monitoring
Our integrated, comprehensive and cost-effective Pharmacovigilance and Medical Information services help ensure compliance with continually evolving regulatory requirements. Our multilingual team of Pharmacovigilance and Medical Information professionals is experienced in Canadian, FDA, and EU pharmacovigilance regulations and reporting standards. This ensures the highest quality of safety data collection and processing to facilitate regulatory compliance across global markets.
Customized reporting of safety information
Our multi-disciplinary team of drug safety specialists provides a range of critical solutions that can be customized to meet your requirements, including support for:
- Standardized compliance monitoring process
- Validated databases with E2B connectivity and gateway submissions
- Reporting of Individual Case Safety Reports (ICSRs) related to Adverse Events (AEs)/Safety Information
- Product Quality Complaints (PQCs)
- MedDRA coding
- Source Data Quality Checks
- Reconciliation
Our responsibility to your business
Our drug safety specialists are trained to ensure compliance with Pharmacovigilance requirements at the intake level, through source data verification and the monitoring of Key Performance Indicators (KPIs). Our expert team stays ahead of your Pharmacovigilance requirements by maintaining the documentation and tools you need, including:
- Health Canada database reconciliation and monitoring
- Risk Management Plans (RMPs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Pharmacovigilance Systems Master File (PSMF) repository
- Audit and Inspection support
- Assistance with procedures or documentation writing
- Centralized, multilingual call centre
- Adverse Events line-listing
- Solicited follow-up requests
- Aggregate/periodic safety reports (PSURs/PBRERs)
- Global and local literature searches and reviews