Our signal management activities follow a structured approach to identify, evaluate, and manage potential safety concerns throughout the product lifecycle.
The process includes the following key steps:
- Signal detection
- Signal validation
- Signal prioritization
- Signal assessment
- Recommendation for action
- Exchange of information and communication
Among these activities, signal detection is one of the most critical and resource-intensive steps. By outsourcing signal detection activities to our experienced team, you can optimize internal resources while benefiting from a robust, high-quality, and scientifically sound safety review process.
Our methodology follows the recommendations of the European Medicines Agency (EMA) for periodic signal detection and country specific requirements. The analysis is tailored according to the specific risk profile, characteristics, and lifecycle stage of each medicinal product.
We apply a combination of qualitative and quantitative approaches, including the use of Standardised MedDRA Queries (SMQs), to identify potential safety signals. Our assessments may also focus on specific adverse event categories, patient populations, or particular circumstances of medicine use, including:
- Off-label use
- Medication errors
- Special populations
- Other product-specific risk factors
Through a structured and risk-based approach, we support clients in the early identification, evaluation, and management of emerging safety concerns, contributing to effective risk minimization and improved patient safety.
« When properly performed, signal detection can be compared to a lighthouse, which will guide your path and prepare you for what is ahead. »
ML PV and Medical Writing Consulting 