Services

Safety

Effective safety monitoring during a clinical trial is essential to the development of a product. GMCS provides clients with expert safety monitoring staff, established safety data collection tools and reports, as well as an established safety reporting processes to ensure all adverse drug reactions (ADR’s) and unanticipated adverse device effects (UADE’s) are correctly collected and reported to the appropriate regulatory authorities in China.

Safety system

• Oracle AERS (Adverse Event Reporting System), integrated with Oracle Clinical

Activities

• Entering Safety data
• Safety Data Review (electronic or manual) and narrative
• Reconciliation

Safety Officer

• MD with many years of hospital practice and clinical trial experience
• Trained in US office and German office on clinical data management and pharmacovigilance