Drug safety and pharmacovigilance is an integral, inter-related component in the complement of clinical research services, which Clinimetrics offers to assist their partners in the development and commercialization of new therapies.
Drug Safety services include:
- Clinical and Post-marketing adverse event (AE) and serious
adverse event (SAE) management from initial data collection
through regulatory reporting
- Narrative preparation
- AERS, ARISg, Argus, Clintrace data entry expertise (including
remote data entry to client systems)
- Expedited United States (US) and international case reporting
- Reconciliation of AEs and safety databases
- Preparation and submission of US Periodic Reports and Periodic
Safety Update Reports (PSURs)
- Data Safety Monitoring Boards
- Audits of safety processes
- Risk management, trend and signal detection
- Documentation of business requirements for database systems
and Standard Operation Procedures (SOPs)
- Business consulting to review client safety systems and processes
Randomization, unblinding
- Temporary staffing with experienced drug safety personnel
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