Pharmacovigilance
Patients come first.
Stay on top of patient protections with better pharmacovigilance.
Detect, assess, understand, and prevent adverse effects and other treatment-related problems — enhance patient care and safety with pharmacovigilance.
Monitor your project within a robust safety system, and ensure consistent communication with safety experts. Quartesian’s expert resources work with your team to create a well-designed safety management plan (SMP) for tests related to medicine testing and usage.
Safety Management Plan
- SMP creation and coordination
- Outline study safety activities and processes
- Define roles, responsibilities, workflow, templates, and actions for safety management
Safety Database
- Create a safety database apart from the clinical trial database
- Record safety data received by the safety department
- Reconcile safety data with clinical adverse event data
- Create and maintain safety database based on study-specific protocol
- In conjunction with client’s Data Management team
Serious Adverse Event Collection and Safety Reporting
- Define overall procedures for the collection, evaluation, and reporting of SAEs
- Prior to first site initiation
- Receive specific details on SAE flow in a safety management plan
- Reviewed and signed by both client and Quartesian
- Process each SAE, evaluate for medical accuracy, and enter into the safety database
- SAEs coded in compliance with CRF coding
Overall Medical Monitoring
- Therapeutic area/indication training of project teams
- Medical support for project staff and the investigator sites
- Monitor overall study conduct and safety
- Evaluate patient eligibility and determine the need for waivers, as needed
- Provide causality assessment for all SAEs
- Coding (MedDRA, WHO Drug) of adverse event information
- Review and resolution of protocol issues
