New York, NY (February 11, 2014) – Clinilabs, a contract research organization that provides early-stage and specialty clinical drug development services to industry, announced today that they have begun offering comprehensive human abuse liability (HAL) testing at their Phase 1 units in NYC and NJ. The company introduced the service in 2013, and is releasing information at this year’s ASCPT conference, where they will be in attendance as a Platinum Sponsor for the 7th consecutive year.
Prescription drug abuse is a serious concern. The FDA estimates that nearly 12% of the American population uses prescription drugs for non-medical purposes. In an effort to regulate the misuse of these medications, government agencies (i.e., FDA, DEA) have set forth strict guidelines for drug manufacturers when developing drugs with high potential for abuse. These guidelines include the inclusion of HAL assessments on recreational drug users for all drugs that affect the central nervous system (CNS), that are chemically or pharmacologically similar to other drugs with known abuse potential, or that produce psychoactive effects such as sedation, euphoria, and mood changes. Despite these requirements and the growing demand for data, there is a small number of organizations that currently offer HAL testing, and only one that is located in a major metropolitan area in the US.
Clinilabs offers access to a team of world-renowned leaders in abuse liability as well as experts in clinical drug development who have a deep understanding of current regulatory guidance, study methodology, clinical care, biostatistics, and medical writing for the assessment of abuse liability. When asked about this groundbreaking initiative, President and CEO, Dr. Gary Zammit stated: “we’ve assembled an expert team for HAL studies, integrated this team into an organization with experience in over 300 clinical trials, and located it in the metropolitan area with the largest diverse population in the world in order to deliver exceptional value to our clients.”
Clinilabs will be unveiling this service at the ASCPT conference in Atlanta, GA beginning on March 18th. Clinilabs will be exhibiting at Booth 200, where members of the Clinical Operations team will be providing attendees with a full understanding of Clinilabs’ Abuse Liability capabilities. As a Platinum Sponsor, Clinilabs invites all attendees to the President’s Reception on Friday, March 21th. The reception is the last official networking event of the conference, honoring ASCPT President John Wagner, MD, Ph.D. For more information on this event or to schedule a private meeting please email your inquiry to info@clinilabs.com or visit www.clinilabs.com/MeetWithClinilabs.
About Clinilabs, Inc.
Clinilabs is a full-service contract research organization (CRO) that specializes in early-phase studies, from first-in-human to end-of-Phase-II. We work with normal healthy volunteers and patient populations, as well as specialty ethnic populations (e.g., Japanese). The company manages multicenter studies worldwide, and owns and operates two Phase I units in the US. Our network of highly qualified investigator sites provides sponsors with top performance for early phase studies. Specialty projects, including pharmacodynamic, biomarker, CNS, cardiovascular, cardiac safety, sleep/wakefulness, metabolic, and Japanese bridging are among our strengths. Clinilabs is recognized globally as a leading specialty CRO, offering a true alternative to large CROs. For more information, please visit www.clinilabs.com.
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