VinCro Clinical Management Services - Medical Safety Monitoring

Services > Medical Safety Monitoring

> Trial Management
> Clinical / Regulatory
> Medical Monitoring
> Data Management
> Biostatistics
> Event Planning
> Trial Cost Estimator

Medical Safety Monitoring

VinCro understands the significance of timely and accurate safety reporting. The medical safety monitoring group at VinCro provides monitoring services of reported serious adverse events 24 hours per day, 7 days a week. The dedicated staff assures the complete, consistent and timely assessment and documentation of serious and non-serious adverse events that meets regulatory requirements throughout the study.

Medical Monitoring services at VinCro include:

Subject eligibility review
Handling requests for protocol deviations
Safety review
- Review of reported serious adverse events
- Reporting to regulatory authorities as required
- Preparation of safety reports
- Adverse event narratives
- Laboratory report evaluations
- Concomitant medication relationships
- Reconciliation of adverse events with case reports and safety database
Medical review of statistical and clinical reports
Medical assessments and summaries for final clinical reports

Disclaimer