Signal & Risk Management
Qinecsa provides tailored signal detection and risk management services for clinical and commercial products.
With diverse therapeutic expertise, our team provide essential analysis on safety data to maintain global compliance and accuracy.
Increase Safety Profile Accuracy
Expert team of qualified physicians, including epidemiologists and clinical physicians along with biostatisticians, to interpret data in line with the complexities of safety assessment.
Limit Regulatory Review Cycles
Global experience of benefit-risk assessments to ensure reduced regulatory comment cycles across regions.
Service Flexibility
Adaptable models to support both evolving and mature safety systems according to client needs.
End-to-end Signal and Risk Management Services
Signal Detection & Management
- Ensuring patient safety by monitoring ICSRs.
- Qualitative and quantitative signal assessment.
- Validating hypotheses from collected signals.
- Experts manage signal detection processes.
Benefit Risk Management
- Ensuring medication benefits outweigh risks.
- Assessing therapy safety across lifecycle.
- Develop Risk Management Plans (RMP).
- Implementing Risk Evaluation Strategies (REMS).
Drug Safety Physician Services
- Expert pharmacovigilance and safety evaluations.
- Regulatory compliance and risk management.
- Comprehensive drug safety reporting services.
- Customized solutions for drug safety needs.
Regulatory Responses
- Timely regulatory response and support.
- Expert guidance for compliance issues.
- Efficient management of regulatory inquiries.
- Strategic responses to regulatory challenges.
End-to-End Signal and Risk Management Services
Qinecsa provides tailored signal detection and risk management services for clinical and commercial products, including associated benefit-risk management activities. With diverse therapeutic expertise and industry-leading technology, our team support the breadth and depth of signal evaluation and risk management obligations for 5,000+ products.
Advancing Drug Safety Solutions to the Next Level
We’re working with life science companies to drive progress and continue protecting lives.
