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

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