Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

Imagine you’re out walking your dog on a nice sunny morning. As you approach the intersection, you see a car attempt to make a lefthand turn, only to be hit by an oncoming car that runs the stop sign.

In the age of Coronavirus, it could well be time to assess your internal controls beyond a gap analysis. Consider what COSO says about assessing compliance internal controls. In its Illustrative Guide ...

Control arms in randomized clinical trials (RCTs) have a key role in isolating the effects of the medical product from those caused by other factors. However, in some cases — such as phase II trials ...

The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...