Safety & Vigilance
Safety Management & Vigilance
Integrate safety collection, review, escalation and post-market vigilance into the evidence lifecycle.
When This Service Is Needed
Needed throughout a clinical investigation and into the post-market phase, wherever adverse events, device deficiencies or safety signals must be captured and reviewed.
How Bioexcel Approaches the Requirement
Bioexcel operates a defined safety management plan covering AE/SAE and device-deficiency workflows, medical review and trend evaluation, escalating per the agreed pathway.
Scope of Support
What Bioexcel Provides
Safety management planAE / SAE / device deficiency workflowMedical reviewTrend evaluationEscalationSafety reporting coordination
Key Deliverables
- Safety management plan
- AE/SAE log
- Trend/signal summaries
- Safety report coordination
Data / Regulatory Interfaces
Feeds into PMS/PSUR, Risk Management and CER benefit-risk conclusions.
Typical Engagement Model
Full-Service PartnershipFunctional Service ProviderProject-Based SupportConsulting & Advisory
Related Services
Discuss Your Safety Management & Vigilance Requirement
Share your program details and Bioexcel can help scope the right level of support.