Phase One Units
Investigator Support Services provides access to 20 Phase I Units for your early phase research and generic drug development. These units
are housed within private/group practices, dedicated research sites, and hospitals. Located in major
urban centers as well as suburban and rural areas throughout the United States, these sites offer access to a diverse range of healthy
volunteers and patient populations.
Research Centers
Research Facilities and Patient Accommodations
Our Phase I Units offer the state-of-the-art facilities you need to conduct your phase I/IIa studies. Averaging 4,700 square feet and ranging
from 5 to 52 beds, many research centers in our Phase I network include 24-hour laboratories and pharmacies, private/semi-private male and
female dormitories with showers, kitchens, study rooms, indoor/outdoor recreation areas, and group activities.
Medical Equipment and Capabilities
ISS sites provide capabilities and testing equipment to conduct all forms of early phase research from first-in- human with healthy normals to
proof-of-concept with special populations. Our experienced clinical pharmacology investigators will provide controlled pharmacokinetic
(PK)/pharmacodynamic (PD), safety, and tolerability studies to get your new compound approved for further testing. Additional beds accommodate
larger drug interaction studies, dose-ranging studies, assessments of various routes of administration, and testing on demographically diverse
disease populations to establish efficacy.
Research Experience
Medical Staff
At each of our sites, fully trained research teams are focused on the safety and care of healthy volunteers and patients. Many sites include
around-the-clock physician investigators, nurse coordinators, pharmacists, and lab technicians. On average, our Phase I Units have a dedicated
staff of 15 who have conducted nearly 35 studies during their seven years of phase I and IIa clinical research.
Healthy Normals
Our Phase I Units have well-trained medical personnel with extensive research experience in early phase
trials. Nearly 90% of our early phase investigators have significant study experience working with healthy normals.
Disease Populations
Our investigators initially assess the safety and tolerability of a study drug in healthy normals and
continue the research in various patient populations. Our network includes investigators with experience treating a variety of special patient
populations in virtually every therapeutic area.
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