Pharmacoepidemiology

Confidence Beyond Compliance

Pharmacoepidemiology helps understand the use and effects of biopharmaceuticals; studies integrate the regulatory objective of understanding the safety & risk management features of a product.

Our team of experts can support you during any stage of drug approval.

• Pre-approval:
  • Assess natural history of disease
  • Perform comprehensive literature reviews
  • Identify risk factors
  • Plan and strategize for early risk management activities
  • Provide advice and preparation for regulatory approval (e.g., Attend mock advisory and/or FDA meetings)
  • Rx-to-OTC switch: Help develop portfolio of safety information based on analysis of spontaneous reports (FAERS, VigiBase, NPDS, DAWN), epidemiology data & clinical trial information.

• Peri- & Post-approval:
  • Plan specific risk management activities to conform to international regulatory requirements
  • Analyze incidence of adverse events and develop regulatory reports (e.g., PADER)
  • Utilize large international population databases to:
    • Design and conduct large cohort & case control studies
    • Calculate persistence, adherence, & compliance with therapy
    • Evaluate compliance with contraindications
  • Form panels of medical experts to adjudicate results / review study designs and conduct
  • Design and implement registries of disorders / chair advisory groups

For details of our poster submissions and journal abstracts, visit the Resource Library