Signal Detection & Analysis

End to end Signal Management Services with advanced Signal Detection Analytics

Signal Management in Pharmacovigilance

Signal detection is a key component of pharmacovigilance and the whole process of risk/benefit evaluation depends on the effectiveness of signal management system.

European Medical Agency (EMA) has launched new EudraVigilance system on 22 Nov 2017 with access to all marketing authorization holders (MAHs)/License holders for monitoring of validated signals from “list of medicinal products underadditional monitoring” and inform the respective national competent authority of member state as per regulation No 520/2012 (article 18).

Based on this regulatory guidance documents (GVP module IX) have been revised regarding process of monitoring and reporting of safety signals.

With the ever increasing scrutiny by regulatory authorities and public, MAHs need to strengthen their signal management systems. National Competent Authorities can request these documentations at any time which requires the proactive safety evaluation and reporting processes to be working efficiently and increased transparency through communication of information/evidence.

Signal Detection Services

iSignalProTM
iSafety Technology integrated Proactive Signal Management System

iSignalProTM provides MAH and regulatory authorities with a clear Signal Pathway from Signal Identification, Signal Monitoring, Signal Review to Signal Closure/Recommendations and Safety Updates.

>> identifies new risks or a change in risk associated with an active substance or a medicinal product.

>> applies advanced data mining techniques to a variety of spontaneous reporting databases including EudraVigilance to identify potential, validated safety signals.

>> covers all steps from detecting signals, through their validation and confirmation, analysis through prioritization and assessment to recommending action.

iSignalProTM mitigates the challenges, often MAH face to remain compliant with their signal management processes, including;

  • Validating a Signal Identification and Review Process
  • Acquiring safety data which is valid and relevant for signal detection process
  • Validating identified safety signal with key clinical assessment parameters
  • Conducting extensive health authority search and also review of all committee safety meeting minutes, scientific literature publications for identifying relevant safety signal
  • Accurate interpretation of safety data and confirming the signal in coordination with safety committee of MAH periodically.
  • Lack of implementation of processes on how to monitor for validated safety signal.

iSignalProTM Business Values

iSignalProTM functions on a global platform and provides MAHs/companies with:

  • Compliant Signal Detection and Management framework with Signal Tracking and Analytics
  • Rapid integration and implementation for global product portfolio
  • Customizable Modules for Risk Based Prioritization of Safety Signals
  • Signal Detection and analysis for the authorized products and New process for signal management in line with the latest Pharmacovigilance legislation
  • Review of current and ongoing signal management practices
  • Assessment of individual case and aggregate reports along with PRAC minutes, safety committee recommendations, health authority updates, literature review for signal evaluation
  • Medical monitoring of safety signals on a periodic basis in safety database and Cross functional knowledge of identifying emerging or potential safety signal over various pharmacovigilance processes for a respective MAH
  • Visual Pharmacovigilance Signals Analytics and Business Intelligence