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.
Drug Safety & Reporting Training
- Covers global/local clinical PV regulations.
- Custom training on EU, US, Canada guidelines.
- Tailored for both PV and non-PV audience needs.
- SME trainers implement custom modules.
Safety Management Plan
- Ensures systematic SAE/SUSAR management.
- Defines roles and responsibilities clearly.
- Covers safety report management framework.
- Experts assist in SMP development.
Drug Safety Tool Kit
- Proactive drug safety planning.
- SOP development for clinical trial safety.
- Training design, implementation, and maintenance.
- Signalling and review of DSURs.
Advancing Drug Safety Solutions to the Next Level
We’re working with life science companies to drive progress and continue protecting lives.
