Safety Sciences Optimization: Signal Management
Are you efficiently delivering compliant and effective Signal Management?
Are you efficiently delivering compliant and effective Signal Management?
- Signal management accounts for 26% of critical MHRA findings, second only to Reference Safety Information (28%)
- Navitas Life Sciences research shows that nearly 50% of companies surveyed do not have a formal system in place for signal tracking
- An optimized and compliant signal management system using a strategic approach enabled by technology and cross-functional governance to identify, assess and track signals
Key Issues Addressed
- Incomplete monitoring of all required sources of potential signals
- Inefficient processes / tools for detecting, prioritizing, evaluating, or tracking signals
- Recent inspection & audit findings in signal management
- Non-compliance with revised EU GVP Module IX
Navitas Life Sciences Provides an Integrated Approach Leading to Impactful Results
- Assessment and redesign of signal management processes and tools
- Gap analysis of signal management processes and governance compared to best practice benchmarks and new regulatory requirements like EVDAS
- Implementation of refined signal management processes, tools, and governance
- Sourcing and project management of the implementation of signal management technology
Deliverables
- A strategic approach to signal management from signal to patient that is enabled by fit-for-purpose technology and cross-functional governance
- Strategies for detection and timelines for each step from identification / detection through to decision and recommendation for action
- A tiered approach to signal detection based on structured product portfolio prioritization to deliver compliant and efficient signal management
- SOPs, work instructions, templates and job aids to support end - to - end the signal management process from
- Simplified oversight through the identification and implementation of fit - for - purpose technology to produce on-demand reports
Benefits
- A compliant and efficient signal management process
- A signal management system based on a strategic approach to signal identification, assessment and tracking that is enabled through technology and governance
- Identification and implementation of appropriate technology to manage and track signals