• News
  • Contact Us

Pharmacovigilance

Overview


Exponent health scientists provide strategic consultative services to pharmaceutical clients in the areas of safety surveillance, epidemiology and risk management. Our scientists use innovative study methods to meet client needs, and have broad expertise in the design, implementation, and analysis of epidemiologic studies. Exponent health scientists, physicians, clinical toxicologists, and statistical analysts provide comprehensive analytical services in the areas of: product efficacy, safety, and economic value. Our statisticians have extensive experience in the identification and analysis of large patient registries, with a goal of quantifying the risks and benefits associated with pharmaceutical agents.

Exponent scientists have an outstanding reputation in the area of product safety evaluation across a wide range of health, environment, and engineering disciplines and our team of statisticians, epidemiologists and clinical toxicologists apply the same rigorous objective evaluations in the of post-marketing surveillance of pharmaceutical and biomedical device products. Exponent has assembled world-class expertise in program design and management, epidemiology, biostatistics, health economics, and regulatory aspects of post-approval programs. The Exponent team is able to assist clients with the following:

  • Design of optimal programs 
  • Development of study plans and materials 
  • Study execution 
  • Data analysis 
  • Preparation of scientific presentations and publications in peer-reviewed journals

Our focus includes products (drugs or device), and diseases or conditions. Our expertise also includes the systematic examination of data using statistical and mathematical tools to determine a potential safety signal that warrants further investigation (data-mining). Our staff have published studies quantifying the adverse effects of cytotoxic drugs in cancer survivors in journals such as The New England Journal of Medicine, Journal of the National Cancer Institute, and Journal of Clinical Oncology, thus, providing a firm, evidence-based foundation for quantification of the risks and benefits of therapeutic drugs.