Our Signal platform is easily optimizable to access structured data form:
- Your company licensed safety database(s)
- Spontaneous reporting data from the FDA Adverse Event Reporting System (FAERS)
- WHO-VigiBase system
- Eudravigilance from EMA
This helps your team members to access all the safety data at one place to perform analysis and signals
We implemented market standard methodologies to assess the data for a clear outcome.
Advanced Datamining, Statistical Analyses and Visualisation
Our statistical metrics are:
- PRR, ROR, OE, Chi-Square scores
- Bayesian statistics of EBGM, MGPS, IC and confidence intervals
- Data from peer-reviewed and published literatures safety algorithms
Regulatory Authorities Worldwide expect Pharmaceutical companies to implement a methodological process to identify the signals for safety of their products in use. There is a standard GVP Module IX issued by the European Medicines Agency (EMA) which is a golden standard followed by the pharma industries around the globe.
Our Pharmacovigilance professionals help you to understand connect the guidelines with our signalling software for better analysis and management of reports.Our system generated reports helps medical safety reviewers with insights to decide on the signal strength and further monitoring
