Pharmacovigilance
ScinoRx has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance services to help our clients address product safety concerns in a confident, proactive manner. We provide diligent resources with the abilities to review, evaluation and management of adverse event reports in accordance with applicable health authority regulations and ICH guidelines.
Our professionals will provide services as below:
- Clinical and Marketed Individual Case Safety Reports.
- Case Management
- Aggregate Safety Reports
- Scientific Literature Surveillance
- Safety Signal Detection
- Epidemiology Consultation
- Risk Management
- Reconciliation
- Reporting rules
- Vendor management
- Database configurational help
- Regulatory Consultation
- Quality and compliance
- Safety analyses in Regulatory submissions
- Data Monitoring Committee (DMC) reviews.
