Proactively manage risks to ensure patient safety
It is no longer enough to report in a timely manner: drug safety processes must now be 100% reliable and cost-efficient. To protect patients from potentially adverse events and increase the success rate of the clinical trials, life science companies need to implement an effective pharmacovigilance (PV) system that satisfies requirements and mandates of regulators and markets alike.
Amid increasing maturity and shifts in regulations globally, as well as a disconnect between industry and regulators, there are many safety challenges to overcome. For instance, how can IT and predictive analytics for PV distinguish between noise and new insights? How can companies work with affiliates, partners, and vendors to manage growth, volatility, and change so that you can sustain compliance, uphold quality, and drive efficiency?
Navitas Life Sciences Is Here to Help
Navitas Life Sciences can help you create and implement an effective lifecycle benefit-risk strategy to ensure patient safety, as well as to keep your products on the market. Navitas Life Sciences has defined and upheld PV compliance with more than 40 life sciences companies to date. We know the future of drug safety and we believe in transforming performance and compliance by improving processes to get you there.
Safety Services include:
- PV consulting and services
- AE receipt
- Case processing
- Aggregate reporting
- Signal detection
- Develop/maintain core RMP
- PV technology platforms
- Integrated Service Offering on the Cloud (BPaaS)
- Document Management
- Support and Maintenance