GlobVigilance’s client-focused teams have expertise in management of activities related to ICSRs to enable on-time reporting around the globe.

GLOBVIGILANCE ensures that periodic reports, safety summary updates, and risk assessment document are created in the proper format with the appropriate clinical content and are submitted to the relevant regulatory authorities within compliant timelines.

GLOBVIGILANCE searches the literature for reports of adverse events for all types of products, using standard terms, triage analysis, and relevant processing for expedited or periodic reporting.

GLOBVIGILANCE performs ongoing signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified and potential signals

GLOBVIGILANCE provides strategic advice and analysis; develops US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMPs) for Europe.