Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last ...

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...

Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an ...

Minor data corruptions can be even more dangerous and costly than a data breach or attack because they often go undetected for long periods. Data corruption is usually caused by incorrect, outdated or ...

As hospitals and health systems accelerate artificial intelligence adoption, industry leaders warn that inaccurate patient ...

A new research report from Yale School of Medicine offers an up-close look at how biased artificial intelligence can affect clinical outcomes. The study focuses specifically on the different stages of ...

AI—both generative and machine learning/statistical—is essentially dead in the water without well-vetted, timely, quality data. This is holding back AI efforts more than anticipated, a recent survey ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...