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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

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


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.

Drug safety took kit

Proactive drug safety planning
SOP development for clinical trial safety
Training design, implementation, and maintenance
Signalling and review of DSURs