New York, N.Y.-based Clinilabs, a specialty contract research organization (CRO), has completed expansion of its phase I unit to 68 beds, including two new large observation rooms that can accommodate up to four beds each.
The company conducts phase I studies in any therapeutic area, including pharmacokinetic (PK), pharmacodynamic (PD), bioavailability (BA), bioequivalence (BE), drug interaction and food interaction studies.
Clinilabs also offers specialty services for complex PD studies, such as those that involve the collection of mood, cognition, psychomotor functioning, EEG, quantitative EEG, evoked potential and imaging data.
“Phase I studies are becoming increasingly complex, and sponsors depend on data from these studies to make crucial decisions about their development programs,” stated Dr. Gary Zammit, president and chief executive officer of Clinilabs.
Established seven years ago, Clinilabs has grown to 176 employees. “We started in 2001 with 12 beds and three PK chairs at our first facility in Manhattan, which was located in a remodeled, hospital-owned apartment building. This facility enabled us to take on small but complex studies, and set the stage for our continued focus on integrated PK/PD studies of a complex nature,” Zammit said.
Clinilabs is looking to expand its phase I work outside of New York but wants to be careful with that growth. “We anticipate the expansion of our facilities outside of NYC in the coming months, but we have not yet settled on the location. It is critical for a phase I site to be in an area where there is access to a pool of experienced and talented workers and where there is access to a wide diversity of study participants,” Zammit said.