Case Studies

Innocent Ignorance

Innocent Ignorance

Innocent ignorance is a term used in an FDA training presentation to categorize an act of noncompliance in a clinical trial that is unintentional.

Malicious Malfeasance

Malicious Malfeasance

Malicious Malfeasance is a term that has been used in FDA training presentations to characterize noncompliance that is due to deliberate action to deceive or mislead.

Scientific Rationale

Scientific Rationale

The Cronos risk-based data monitoring method has now been implemented by many major pharmaceutical companies in domestic and international trials. Although the algorithms are empirically validated before deployment, participation in these large clinical trials has helped prove the systems worth in a real-world context. The results shown below demonstrate how effective the product has been in reducing error and rater drift as well as how this method compares to more cumbersome processes that attempt to deal with these issues.

Surprising Sloppiness

Surprising Sloppiness

Patient recruitment and selection for certain indications can be challenging - especially if the condition is rare and the patient population is widely distributed.