DZS is committed to ensuring the health and wellbeing of patients and consumers and to collaborating with pharmaceutical clients to meet the increasingly complex regulatory requirements within the global pharmacovigilance landscape.

Our full range of services offer end to end case processing, efficient management, effective governance and continuous process improvement from early stage clinical development to marketed product support. Through skillful metrics management, dashboard reporting, quality compliance and adherence to regulations and customer needs, DZS creates value across the entire spectrum of pharmacovigilance.

At WDB Group we have motivated pharmacovigilance staff with organizational stability who bring years of experience from within the company, various CROs and the pharmaceutical industry.

Case processing

  • Multilingual Individual Case Safety Report (ICSR) Processing
  • MedDRA Coding
  • Narrative Writing
  • Global Expedited Case Reporting and Management
  • PV Consultancy and Project Management

Aggregate reporting

  • Global periodic safety reporting (PADER, PSUR/PBRER)
  • Provide support for ASR/DSUR
  • Provide medical review support
  • NDA and IND submissions (supporting preparation of IND/NDA annual reports, NDA ISS sections and clinical study reports)
  • Addendum reports
  • Summary Bridging Reports (SBRs)
  • Drug Safety Reports (DSRs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Detection

  • Assessment strategy-routine and/or proactive data mining for signals
  • Screening, identifying, prioritizing, analyzing, evaluating and reporting
  • Medical event surveillance and monitoring
  • Signal event analysis
  • Tracking and trending of safety signals based on intervals
  • Comparative and statistical analysis based on external reporting databases (AERS and WHO vigibase)
  • Evaluation of potential signals from aggregate analysis
  • Formal analysis report generation