Safety Surveillance and Signal Management
We offer extensive hands-on experience in routine and targeted safety surveillance for investigational products across Phase I–III development, newly approved medicines and established marketed products.
Services include:
- Development of product-specific safety surveillance strategies
- Review of case-level and aggregate safety data
- Signal detection using qualitative and quantitative approaches
- Signal validation, prioritisation, assessment and evaluation
- Medical review of cumulative safety data and relevant scientific literature
- Assessment of clinical and non-clinical evidence including literature articles relating to potential safety issues
- Characterisation of identified and potential risks, including frequency, seriousness, severity, reversibility, clinical consequences, risk factors and susceptible populations
- Preparation of signal evaluation reports and documented company positions
- Development of recommendations for labelling changes, additional monitoring or other risk-minimisation measures
- Preparation of responses to health authority questions concerning signals and emerging risks
Proactive surveillance and rigorous cumulative review enable the early identification of potentially important or contentious safety issues. This allows companies to anticipate regulatory scrutiny, undertake timely benefit–risk evaluation and develop scientifically robust positions.