European Medicines Agency Selects Aetion to Support Safety and Efficacy Research in Europe
Aetion has been selected by the European Medicines Agency to support the agency’s Quality, Efficacy, and Safety Studies on Medicines. Aetion is a health care analytics company, working to provide real-world evidence for regulators, manufacturers, and purchasers of medical treatments and technologies. The company was founded by Harvard Medical School faculty members and uses its Evidence Platform® to analyze data and produce honest scientific answers about value, safety, and efficacy. Aetion will perform pharmacoepidemiologic research for the European Medicines Agency and generate real-world-evidence to aid measurements in safety and efficiency of medicines used in routine clinical practice.
Aetion’s contract designates a research purview including studies about health outcomes in differing populations over specific time periods, how exposure and a health outcome are associated, and the impact of an intervening vaccine. The company is partnered with Cegedim Health Data, enabling its access to The Health Improvement Network® database. This database covers large populations of patients across Europe, over 69 million patients.
Aetion Co-founder and President Dr. Jeremy Rassen said that the European Medicines Agency’s selection shows the value of their programs and the trust they generate. “We are proud to support–and are deeply aligned with–EMA’s strategy to leverage health care data for regulatory decision-making, including to ensure the efficacy and safety of medicines,” he said.
Aetion’s Evidence Platform is used worldwide by global regulators. The U.S. Food & Drug Administration selected it to develop a system of studies to better prepare for future pandemics. Aetion also partners with the National Institute for Health and Care Excellence in the UK to find ways to use real-world-evidence to study real-world clinical effectiveness.
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