Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) in compliance with the European Union (EU) Medical Device Regulation (MDR). Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical […]
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Risk Management Consulting (RMC), a health services research firm, offers Research, Safety, and Epidemiology services with experience in the healthcare consulting and biopharmaceutical industries. RMC provides the health care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. RMC’s projects range from retrospective to […]
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Tags: comparative effectiveness research, drug, health outcomes, large-scale studies, medical device safety surveillance, pharmacoeconomics, pharmacoepidemiology, prospective studies, retrospective studies, risk management, vaccine Comments Off on Combining Research, Safety, and Epidemiology“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type […]
Posted in Featured, Regulatory Medical Writing Comments Off on Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.