seQure provides customers with a complete portfolio of drug safety and risk management services for the collection, monitoring, assessment, and analysis of drug safety information and the detection of new adverse events. Using our network of resources, we can provide cost-efficient data entry and case collection as well as expert quality control consultancy and reporting to the appropriate authorities.

Periodic Reporting

  • Preparation of PSUR/DSUR according to ICH format with document QC and submission report
  • PSUR/DSUR Calendar development and maintenance
  • Preparation of listings and distribution to involved Investigators
  • Preparation and ad hoc safety reporting
  • Trend Analysis

Literature Screening
Signal Detection &
Risk Management Plans 

  • Weekly searches of worldwide scientific literature according to key search parameters
  • Preparation and management of Risk Management Plan (RMP)
  • Performing searches of local scientific journals
  • Ad hoc statistical analysis and data mining

Case Collection & Data Entry

  • Coding
  • Narrative Writing
  • Medical Review
  • Case approval & reporting to Eudravigilance and to any competent authority (EU/non-EU)
  • Report Submission
  • Management of ICSRs from Eudravigilance

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