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Sponsors, CROs, regulators, sites and opinion leaders have discussed the pros and cons of a risk-based approach to field monitoring for years. The pharmaceutical industry always sought guidance from the FDA, and different approaches for reviewing data collected by sites.

Workers from France, Italy, and Spain account for more than a third of total staff at the European Medicines Agency, plus around 68% of agency staff members are women, according to new statistics.

Medidata Minute Episode 1: Harlan Krumholz, Professor of Medicine, Epidemiology, and Public Health, Yale University School of Medicine discusses the role of data analysis in improving healthcare outcomes for patients