Princeton, N.J., 2022 年 3 月 17 日 — Certara, Inc. today announced a four-year, framework service contract with the European Medicines Agency (EMA) to advance regulatory decision-making in the human medicines domain with advanced statistical and pharmacoepidemiological research. The Company will develop innovative study designs and conduct pre- and post-authorisation real-world, risk-benefit studies.
“On their own, trial data are not able to conclusively identify and assess the full impact of a new healthcare technology. We are excited to use our deep statistical and pharmacoepidemiological expertise and tools to assist the EMA in research that strengthens understanding of the real-world impact of new therapies by addressing regulatory questions with fit-for-purpose solutions,” said Nadia Quignot, Ph.D., Director, Real-World Data Solutions at Certara.
Gathering and analyzing real-world evidence are crucial to understand the impact of medicines, including clinical effectiveness and adverse drug reactions. Pharmacoepidemiology brings together the disciplines of epidemiology, pharmacology, and biostatistics to understand the effects of drugs in large populations, requiring not only quantitative expertise but also advanced modeling tools.
“We are pleased to be chosen by the EMA to conduct pharmacoepidemiological studies and mine actionable insights from real-world data to support critical regulatory decisions,” said Dr. Terri Madison, general manager of Evidence and Access at Certara. “Through this framework contract, Certara looks forward to assisting the EMA in its strategy to incorporate and analyze all types of healthcare data to promote optimal benefit-risk for authorized medicines.”
Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.