Clinical Safety Management
Safety and Regulatory Compliance Experts
Qinecsa’s clinical safety management services include thorough safety assessments that examine all PV aspects of a clinical program. We focus on and offer tailored services to analyse risks, identify strategies, and implement effective infrastructure and standardised processes to improve efficiencies and workflows. Our approach is systematic and evidence-based, drawing on years of experience working with diverse companies and therapies.
Navigating the complex world of PV regulations requires specialised knowledge. Our team possesses extensive expertise in SAE/SUSAR management, SAE reporting, reconciliation processes, annual safety reports, and clinical signal and risk management. We ensure your solutions both meet and exceed regulatory requirements, demonstrating your commitment to clinical safety.
We also develop robust clinical SOPs that thoroughly document your system’s safety features, potential hazards, and mitigation measures. Our pharmacovigilance experts work collaboratively with your team to create comprehensive documentation that satisfies regulatory requirements whilst providing a clear roadmap for ongoing safety management.
Safety Training and Knowledge Transfer
We believe in empowering your team with the knowledge and skills needed to maintain clinical safety standards long-term. For example, our drug safety and reporting training covers all aspects of global and local clinical PV regulations and more.
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.
Working with Qinecsa for Your Needs
We are committed to ensuring that your systems not only meet regulatory standards but work to protect lives. With Qinecsa, you can focus on your core business goals while we handle safety compliances. Our flexible services allow us to provide the support you need throughout the clinical product development followed by commercialisation.
