Epidemiology Reviews & NIS Design

Epidemiology is the study of the distribution and determinants of health-related states or events (including disease), and the application of this study to the control of diseases and associated health problems.

Pietrek Associates consultants have more than 25 years of experience in epidemiology.

Key Deliverables

  • Systematic literature review of targeted indication    
  • Quantification of disease-specific adverse events
  • Definition and quantification of unmet medical need    
  • Pharmacoepidemiology for safety signal investigation
  • Design of natural history of disease studies    
  • epidemiology reviews and nis designSupport of consultations with regulatory authorities for new or existing marketing authorizations
  • Identification of data sources for observational studies    
  • Project management of pharmacoepidemiology studies
  • Review of study options and appraisal of feasibility    
  • Training on pharmacoepidemiology


  1. Systematic literature reviews of selected conditions in CNS, cardiac and metabolic disorders,
    infections, oncology
  2. Design of drug utilization studies in adult and pediatric oncology patients to assess off-label use
  3. Design of post-authorization safety studies focusing on potential long-term risks
  4. Feasibility studies for secondary use of routine data (health records)
  5. Evaluations of risk minimization effectiveness