Pharmacovigilance
We understand the importance of ensuring drug safety and minimizing risks associated with the use of medication. Our pharmacovigilance services are designed to help our clients comply with regulatory requirements, identify and assess potential safety concerns, and monitor adverse events related to their products.
Drug Safety—Detection. Collection. Assessment. Monitoring.
Clinical research and patient support programs play a crucial role in the identification of real-world data that can impact a product’s development over time. Dosing or administration changes—and even new indications—can occur as a result of adverse events or product quality complaints that our pharmacovigilance experts detect.
Our pharmacovigilance services provide customizable solutions that are compliant with local regulatory requirements. We work with our clients to develop product-specific standard operating procedures for timely adverse event reporting, tracking and reconciliation. Our pharmacovigilance experts undergo extensive annual client-specific adverse event and product quality reporting training to ensure the specific requirements for timely reporting are met.
Our pharmacovigilance services include:
Adverse event detection and identification: Our proprietary software system uses sophisticated data analysis to detect potential safety concerns associated with our clients' products.
Case processing and reporting: We provide end-to-end case processing services, including case intake, triage, data entry, medical review and regulatory reporting. Our team follows strict quality standards and timelines to ensure timely and accurate reporting of adverse events.
Source data verification and adverse event reconciliation: Our source data verification processes ensure the accuracy and completeness of safety data. We offer adverse event reconciliation services to identify and resolve any discrepancies, duplicates or inconsistencies in the reported data.
Risk management planning and implementation: We work with our clients to develop risk management plans that are tailored to their specific products and target populations. Our team also provides support for the implementation of risk minimization measures.
Adverse Event Tracking
Our adverse event (AE) tracking system is a customizable, fully integrated program for the collection and reporting of adverse events and product quality complaints. Program documentation is reviewed by our experts to identify issues, ensuring:
- Error-free DSS reconciliations and source data verification (SDV) audits
- Excellent record of client pharmacovigilance audit and supplier quality assessment results
