QPS, a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development, has expanded its U.S.-based Phase I clinical trial capabilities to support the growing needs of its pharmaceutical, biotechnology and CRO partners. 
 
To meet growing client demand in all areas the CRO has increased early-phase clinical capacity by more than 20 percent at its clinical site in Miami, FL. In addition, it doubled its specialty lab space at its Miami site and co-located it with its Miami-based clinical site. 
 
To fill their drug pipelines, large pharmaceutical and biotechnology companies are buying promising drug compounds that have been developed by small biotech companies up to the point of candidate nomination. These promising compounds then become candidate drugs that the large companies put through rigorous testing and analysis before potentially being reviewed and assessed for approval by the FDA.
 
“We’ve seen this trend evolve and have expanded our Phase I clinical trial capabilities to better serve the hundreds of smaller companies developing potential new drugs. We have completed more than 150 Phase I trials and this expansion will enable us to support exponentially more sponsors as they progress compounds through proof of concept and First-in-Human trials to the point of candidate nomination,” said Benjamin Chien, chief executive officer, QPS. “This strategic expansion complements our work with pharmaceutical and biotechnology companies, as well as our CRO partners, where we have successfully conducted more than 1,300 Phase I-IV clinical trials for drug candidates. Engaging smaller biotechnology companies is key in expanding QPS Phase I capabilities, and these companies don’t have large research or clinical pharmacology departments.”
 
QPS appointed Marcelo Gutierrez to serve as its director of clinical pharmacology so sponsors can tap into his experience working for three well-known pharmaceutical companies.
 
“Our pipeline is filled with sponsors that need this level of support. The amount of First-in-Human studies are rapidly increasing and there are very few sites across the country that can conduct them,” said Mr. Gutierrez. “QPS is well-known for its success in First-in-Human studies.  We excel at complex and special population Phase I trials, and our enrollment and completion rates are among the best in the industry.”
 
With the expansion comes an increased focus on quality. “To ensure the quality of our clinical trials is maintained, QPS has hired two additional full-time principal investigators to ensure dedicated, physician-involvement at every stage of our trials,” said Mr. Chien. “We now have five full-time principal investigators, and a network of more than 25 board-certified subspecialty physician investigators to support the increased volume of studies in our pipeline.”
 
Sandra Pagnussat joined QPS as a primary investigator dedicated to Phase I trials. The CRO also appointed Aliza Lipson, an adult rheumatologist, to the role of primary investigator dedicated to late-phase clinical trials.