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
Support 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
Examples
Systematic literature reviews of selected conditions in CNS, cardiac and metabolic disorders, infections, oncology
Design of drug utilization studies in adult and pediatric oncology patients to assess off-label use
Design of post-authorization safety studies focusing on potential long-term risks
Feasibility studies for secondary use of routine data (health records)
Support of consultations with regulatory authorities for new or existing marketing authorizations