Global Pharmacovigilance
Tailored safety models providing comprehensive medical monitoring and clinical safety planning.
Integrated Safety Model
Our safety model is tailored to the protocol, product, countries, sponsor systems, case workflow, reporting responsibilities, and required medical oversight. Globyz Clinical Solutions coordinates this service in collaboration with CEBIS USA LLC, its U.S. affiliate and clinical research arm. The teams work together within an agreed delivery model, and clinical studies are conducted through CEBIS USA.
Discuss Your Safety Requirements
Safety Excellence
Global compliance & oversight
Pharmacovigilance Capabilities
Clinical Safety Planning
- Safety management plan and responsibility matrix
- Safety database and case workflow interfaces where applicable
- Serious adverse event review and reconciliation support
- Expedited reporting coordination according to assigned responsibilities
- Safety communication and escalation pathways
Medical Monitoring
Medical monitoring may include protocol and eligibility questions, review of relevant clinical and laboratory data, medical issue escalation, investigator support, and input to safety decisions according to the agreed medical monitoring plan.
Aggregate and Periodic Support
Where included in scope, support may cover safety listings, trend review, aggregate report inputs, development safety update materials, and reconciliation with clinical and regulatory documents.
Defined Interfaces
The safety model identifies the sponsor, investigator, medical monitor, pharmacovigilance provider, clinical team, data team, vendors, timelines, and reporting authority for each activity.
Partner With Globyz
Share the protocol or synopsis, product details, expected safety reporting timeline, and regulatory responsibilities to get started.