Signal Detection / Risk Management


The main objectives of Pharmacovigilance activities through its product life cycle are to identify new potential risks and facilitate development of an effective risk minimization/mitigation plan to prevent/mitigate such risks.

Mediscribe signal detection team performs ongoing signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified potential signals.

Mediscribe risk management team provides strategic advice and analysis; develops INDIA Risk Evaluation and Mitigation Strategies (REMS) and REMS update reports and compliance; writes and updates Risk Management Plans (RMPs) for Europe.

Our Core :

  • Screening, Analysis, data mining and frequency tabulation for potential signals, including signal estimation using established statistical signal detection methods
  • Routine (monthly, quarterly, bi-annual, annual) and ‘ad hoc’ signal detection activities, generate signal reports and track signals for client products
  • In-depth evaluation and validation of potential signals by further medical analysis of case series, targeted literature search and review of data from external databases