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.
- 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