David Benigson is CEO of Signal AI, a company using AI and media data to help executives cut through noise and drive actionable insights. Risk is no longer a four-letter word—it's a critical factor ...

The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations ...

Organizations are integrating previously disparate services to better align their offerings with the shift from fee-for-service to risk-based care through visionary, member-centric solutions. For ...

US and EU officials explained on Wednesday what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times. Under a cooperative ...

Brand risk rarely appears as a dramatic breach announcement. More often it emerges quietly in places nobody was watching closely enough. A cloned login page that remains online for weeks. A supplier ...

WASHINGTON--(BUSINESS WIRE)--The Association of Clinical Research Organizations (ACRO) has released two white papers on risk-based monitoring and risk based quality management, titled Establishing ...

Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...