Signal Management Services
Signal management is one of the key aspects of pharmacovigilance. It’s the process of identifying, analyzing and evaluating potential safety issues with pharmaceuticals. A safety signal is information about an adverse event that may have been caused by a drug or medical device.
The signal management lifecycle helps identify, validate and assess safety concerns. After considering the validity of safety signals, organizations can make better benefit-risk decisions to ensure patient safety.
We have many years of experience in the field of pharmacovigilance and can assist with signal management, providing oversight, assistance and recommendations to pharmaceutical companies.
Regulatory Aligned Safety Monitoring
Our team provides complete support in pharmacovigilance by helping you:
- Identify, validate, and confirm safety signals
- Perform in-depth analysis and prioritization
- Establish best practices for regulatory compliance
- Implement processes that support safe, effective products
We follow Good Pharmacovigilance Practices (GVP) and guidelines from leading industry working groups to ensure that your product monitoring is both effective and compliant.
Customized Support
Our vast industry expertise covers all life science areas. We provide services for biotech companies, clinical research organizations and pharmaceutical organizations. Whether you’re in the process of developing new drugs and medical devices or you have an existing portfolio of products to track, our PV support helps you develop a suitable methodology for assessing signals and evaluating the safety of your products.
Let’s Talk About Your Safety Strategy
Signal management is just one part of an overall pharmacovigilance strategy. For life sciences companies looking to trade internationally, having sound policies for signal management, communication and safety is essential. Individual territories set their own requirements for documentation, reporting and safety. Our team can help you maintain audit-ready documentation.To learn more about how we can build or refine your organization’s safety strategy, contact us now to schedule a no-obligation consultation.