Clinical safety management
Qinecsa offers an extensive array of services, tailored to meet the specific requirements of your clinical program. No matter the kind of support you need, we are here to provide assistance.
Our established and proven team delivers scalable, compliant, and robust pharmacovigilance services to clients.
Sustained, consistent, and high-quality delivery
Engagements are led by pharmacovigilance experts who understand the requirements of regulators, client challenges, and the evolving landscape.
Service flexibility and scale
Tailored services to meet clients’ changing needs including flexibility to respond rapidly to project demands and deviations and achieve long-term client loyalty.
Cost effective services
Robust infrastructure with standardized processes supported by tools to monitor workflows, to deliver class-leading efficiency for clients.
Value added clinical safety support services
SAE and SUSAR management
- Tailored approach data management
- In-house safety database /EDC custom-designed
- Solutions for SAE reporting, efficient queries
- Efficient reconciliation process
Medical review and reporting
- Global clinical case review and analysis
- Trial investigator and Ethics Committee reports
- Regulatory authority reports (EU/global)
- Signaling, DSUR, and IND Annual reports.
Safety management plan
- Highly specialized PV physicians
- Expertise in patient safety profile assessments
- Safety data listing review and signaling analysis
- Large team of clinical senior safety specialists
Drug safety took kit
- Proactive drug safety planning
- SOP development for clinical trial safety
- Training design, implementation, and maintenance
- Signalling and review of DSURs