Pharmacovigilance

We offer Pharmacovigilance services for clinical and post-marketing safety surveillance, safety regulatory affairs, medical affairs, training, contracting, and consulting to the pharmaceutical industry. The handling of safety information is an essential component of a clinical trial, and an integral part of Good Clinical Practice (GCP). Regulatory guidelines around clinical trial safety monitoring and reporting demand strict safety management procedures, from a highly-skilled and experienced safety team. Globyz Clinical works closely with the clients to understand the specific safety requirements of each trial. As your partner, we will facilitate to implement a robust management system for project documentation, data collection, and generation of all required regulatory and periodic reports. Our Safety and Pharmacovigilance Services include: Our Safety and Pharmacovigilance Services include:

• Study-specific training for Investigational Sites on Safety Reporting
• Study-Specific Safety Database set up
• Preparation of the Study Specific Safety Reporting Plan, Safety Reporting Forms and relevant guidelines for the Investigational Sites
• Receipt and processing of Individual Case Safety Reports
• Data entry, Medical Coding (MedDRA and WHODD), QC, Medical Review and Distribution
• Follow-up and query management
• Expedited reporting of SUSARs and other safety information such as Significant Safety Issues and Urgent Safety Measures to relevant stakeholders such as Regulatory Authorities, ECs and Investigators
• Periodic Safety reporting to local ECs and Investigators
• DSUR distribution and submission to Investigations and ECs
• Preparation and submission of Annual Safety Reports