Experience

With over 800 Phase I-IV studies performed over the last 15 years, our staff has the knowledge to conduct studies to meet your highest quality standards. Our clinical research team members and senior staff have significant knowledge and experience in the CRO industry and in conducting clinical trials. Together, our leadership team has worked in the pharmaceutical industry for more than 167 years.

We also have an enviable record of retaining employees with a turnover of less than 5 percent, and our average tenure is 6 years even after our major expansion. That means the people working on your study today will likely be the same people you work with on your next study.

As a measure of staff quality, we have been inspected by the Food and Drug Administration (FDA) on ten separate occasions, with only one minor violation recorded in a 483. We have never received an FDA Warning Letter.

Recent Challenges

• A 1200-person study with subjects ages 40 to 90-plus, where 80 percent of the subjects had to be 60-plus years old and all had to be recruited and started within four weeks. Over 16,000 samples were collected.

• A four-way crossover study involving 90 postmenopausal women where one of the four confinement periods fell over a holiday weekend. QPS Bio-Kinetic recruited and completed the study in less than eight weeks.

• Seven studies were completed on the same compound in which subjects were required to be compound-naïve. Each study required between 116 and 140 subjects, approximately equal numbers male and female, as well as a multi-period in-house confinement and required returning visits to the clinical research unit over the next three months.