Category Archives: Clinical

In order to avoid a 483 and possibly an FDA warning letter, you must be prepared for a site inspection from FDA.  Following the 5 essential tips below will help you and your site prepare for, and successfully pass, an FDA audit: Assume you WILL be audited. By keeping this mindset, whether you receive aContinue Reading

Choosing the right investigator to conduct a clinical study is the key element in a successful trial. Investigator training during the duration of a clinical study is important in the outcome of the trial not only to the sponsor but also to ensure patient safety is being monitored. In 2011 alone the FDA issued warningContinue Reading

Monitoring is one of the most essential aspects of a clinical study. But what happens if your monitors are untrained or make costly mistakes? After spending millions of dollars and years of hard work, the results could very well render your study insufficient by the Food and Drug Administration. Common monitoring mistakes include: Not havingContinue Reading

A chart recently posted on the Clinuity Blog depicts clinical professionals’ most often-cited “causes of clinical trial delays.” It typifies many of the administrative issues that can slow down a study, such as patient recruitment, which came in second. It’s an age-old adage: time is money. And a major factor in cutting the costs ofContinue Reading